{"paper_id":"41f85d61-8275-45cd-96cb-844f7e073828","body_text":"Comparing the effectiveness of radial Extracorporeal Shockwave therapy (rESWT) and three conventional treatment approaches for biceps brachii muscle in exercise-induced Delayed Onset of Muscle Soreness (DOMS): A Protocol for a Randomized Clinical Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Comparing the effectiveness of radial Extracorporeal Shockwave therapy (rESWT) and three conventional treatment approaches for biceps brachii muscle in exercise-induced Delayed Onset of Muscle Soreness (DOMS): A Protocol for a Randomized Clinical Trial Azharul Islam, K. M. Amran Hossain, Md. Feroz Kabir, Sharmila Jahan, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4330620/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Delayed onset of muscle soreness (DOMS) is a typical physiological response to unaccustomed to intense exercise, characterised by pain, stiffness, and reduced muscle function. DOMS is often experienced in muscles after strenuous limb activities, impacting an individual's physical performance and overall well-being. Effective management strategies for DOMS are essential to minimise discomfort and enhance recovery. In the treatment of DOMS, physiotherapy management is a better option rather than analgesics or NSAIDs. There is a research gap on radial extracorporeal shockwave therapy, rESWT, MFR, cryotherapy, etc. that has an individual and unique effect on pain reduction and functional improvement. Method An assessor and participants-blinded randomised clinical trial (RCT) will be used for the investigation. The impact of rESWT, MFR, and stretching combined with cryotherapy on exercise-induced DOMS will be examined in this study. On the patient, DOMS will be induced for research purposes. Three groups will receive rESWT, MFR, and stretching in addition to cryotherapy. After DOMS is induced, the treatment will be given once daily for 0 to 48 hours (3 times in 3 days). Each group will include 40 students, and the research will measure how rESWT, MFR, Cryotherapy, and Stretching affect pain alleviation before treatment (pretest), immediately after treatment (post-test 1), 24 hours later (post-test 2), 48 hours later (post-test 3) and 72 hours later (post-test 4). The outcome metric will be pain intensity and ROM. Male and female students of the University with good physical health and without a history of taking painkillers recently make up the study’s groups. Discussion The study investigates the efficacy of physiotherapy approaches (rESWT, MFR, Cryotherapy, and Stretching) on exercise-induced DOMS. It addresses a research gap regarding rESWT’s effectiveness and offers valuable insights into pain reduction methods. The findings can guide comprehensive pain management and individualised recovery strategies. Trial registration CTRI/2023/08/056649 [Registered on: 18/08/2023] Muscle Soreness Myofascial release Cryotherapy Extracorporeal Shockwave therapy Figures Figure 1 Background Delayed Onset of Muscle Soreness (DOMS) represents the micro-trauma in the muscle [ 1 ] characterised by the feeling of pain, discomfort, and decreased range of motion (ROM), which is induced 1 to 2 days after high-intensity exercise [ 2 ]. It is also determined as a grade-1 muscular injury in general, seen in recreational or amateur athletes [ 3 ]. Sometimes, DOMS appear after unaccustomed eccentric muscle contraction and unfamiliar exercise [ 4 , 5 ]. Some studies suggested that isometric [ 6 ] and forceful concentric work cause a lesser extent of DOMS [ 7 ]. DOMS refers to the sensation of soreness, pain, stiffness, swelling, and reduced muscle function, which might impair the capacity for performance. The symptoms of DOMS have a regular progression from weakness and discomfort after exercise. The pain progresses after 24 hours; peak pain intensity is seen in 48 to 72 hours. The pain intensity is mitigated within 7 to 10 days after exercise [ 8 ]. In sports overload, skeletal muscle injuries are more common, and it describes incidence near about 10–55% of all sports-related injuries [ 9 ]. Though DOMS is not severe muscle damage, it usually causes a harmful impact and compromises sports performances. There is a lack of epidemiological evidence to demonstrate the overall view, as most of the time, DOMS remains undiagnosed and unassessed cases [ 10 ]. There are several mechanisms by which DOMS can be described, such as muscle spasm, lactic acid formation, connective tissue and muscle damage, muscle inflammation, and enzyme efflux theory [ 11 ]. The most known mechanism of DOMS is lactic acid formation. It is the process where toxic metabolic waste products accumulate in the injury site, causing delayed pain sensation [ 12 ]. However, some studies describe other mechanisms of DOMS [ 13 ]. The muscle spasm theory describes that DOMS sensation is caused by an ischemic accumulation of metabolic waste products during exercise [ 14 ]. The inflammatory theory explains DOMS occurs through muscle responses to exhaustion as oedema formation, inflammatory cell infiltration, and temperature rises. These responses occur due to the degradation of the lipid and protein structure and the accumulation of different chemical mediators in the injury site, which leads to DOMS [ 15 ]. Enzyme efflux [ 16 ] and connective tissue theory also describe the DOMS mechanism. DOMS can be identified or diagnosed in different ways. In general, by evaluating or examining the clinical signs and symptoms like 1) inspecting the muscle appearance, swelling, and colure, 2) muscle palpating, and 3) functional testing and pain measurement. These examinations must be held within 1 and 2 days after an unaccustomed eccentric exercise [ 10 ]. Several imaging methods have been used to assess the DOMS, including ultrasound, magnetic resonance imaging (MRI), and shear wave electrograph [ 17 ]. MRI and conventional ultrasound imaging analyse low to high-grade muscle damage and injury. Chemical and laboratory tests, such as creatine kinase (CK) activity level, are also used to diagnose muscle injury. [ 10 ] The proposed mechanism of DOMS needs proper treatment procedures to reduce pain intensity early, improve functional activity, or prevent further injury. Treatment strategies can be administrated differently, like prophylactically for prevention purposes and conservative management, including Pain medication and Physiotherapy management for curative purposes. As a part of medical management for DOMS, Non-steroid anti-inflammatory (NSAID) drugs are widely used, e.g., diclofenac, naproxen, etc. Which helps reduce pain and inflammatory response [ 18 ]. However, in the case of a mild form of muscle injury, NSAIDs do not need to be used because a study suggests that NSAIDs have a negative effect on skeletal muscle regeneration as well as inhibit inflammatory responses [ 19 , 20 ].In the treatment of DOMS, physiotherapy management is a better option than analgesics or NSAIDs [ 21 ]. For this circumstance, physiotherapy management for DOMS is a better option where various types of methods are used, like stretching, cryotherapy, myofascial release (MFR), extracorporeal shockwave therapy (ESWT), acupuncture, and compression [ 22 ]. Stretching is a therapeutic technique that promotes muscle extensibility, enhances flexibility, and lengthens tissue [ 23 ]. In DOMS, stretching helps to reduce muscle spasms by elongating muscle and increasing circulation on muscle. It is also used as a prophylactic method [ 24 ]. As conservative management, Cryotherapy is also used to manage acute pain and muscle injury. The use of cold on the injured side has an analgesic effect and reduces the signs of muscular damage. However, a study suggests a very mild impact on the perpetuation of muscle tenderness or strength deficit [ 25 ]. One study also describes the use of cryotherapy to improve soft tissue injury by reducing swelling, circulatory effect, and intravascular pressure [ 26 ] Myofascial release (MFR) helps to treat DOMS. This technique acts as a direct, gentle, sustained force for relaxation of the contracted muscle, improvement of venous and lymphatic circulation, and stimulation of stress reflexes [ 27 ].MFR also has a crucial role in reducing pain and soreness and improving muscle excitability. Evidence suggests that MFR also has a remarkable effect on muscle flexibility and helps to reduce exercise-induced muscle soreness [ 28 ] To reduce pain and inflammation in DOMS, shockwave therapy is another treatment approach. As a part of shockwave therapy-Focused extracorporeal shockwave therapy(fESWT) and radial extracorporeal shockwave therapy (rESWT) are widely used to treat muscle injury including tissue healing and pain reduction [ 29 ]. A study suggests that focused extracorporeal shockwave therapy significantly reduces pain intensity [ 30 ]. Besides, rESWT helps specifically to reduce musculotendinous pain and muscle triggers. A retrospective analysis describes that rESWT significantly improved in reducing grade 1 and grade 2 acute muscle injury [ 31 ]. However, there is no study to see the effectiveness of rESWT on exercise-induced DOMS, and there is also no clear evidence of rESWT compared with other treatment approaches, including MFR and Stretching. So, it is necessary to study the individual effects of rESWT, MFR, and Stretching and evaluate the combined implementation of these treatment approaches. So, the study aims to evaluate the effectiveness of rESWT, MFR, and stretching on exercise-induced DOMS as separate interventions along with cryotherapy and compare the effectiveness of these three approaches. The study's objectives are as follows: 1) To evaluate each group's sociodemographic status and baseline compatibility. 2) To find the effect of rESWT, MFR, and Stretching with cryotherapy on pain reduction in exercise-induced DOMS for biceps brachii muscle 3) To elicit the within-group differences of rESWT, MFR, and Stretching with cryotherapy to mitigation of pain in (immediate post-test-1),24hr post-test-2, 48hrs post-test 3, and 72 hours (post-test-4) compared to baseline and 4) To find out the effectiveness among groups (of rESWT, MFR, and Stretching with cryotherapy) and observations (pretest to post-test 4, pretest to post-test1, and post-test 1 to post-test 2, post-test 2 to post-test 3) comparison in the mitigation of pain and ROM. This study has two-tailed hypotheses: Using rESWT, MFR, and Cryotherapy to treat exercise-induced DOMS has different efficiencies in pain reduction and healing. Also, rESWT is more effective than MFR and Cryotherapy in pain remission. Methods Study design The study will be an assessor- and patient-blinded Randomized Clinical Trial (RCT). It will investigate the effect of rESWT, MFR, and stretching with Cryotherapy on exercise-induced DOMS. Study setting The study will be conducted at Jashore University of Science and Technology (JUST), Jashore, Bangladesh. The participants will be recruited voluntarily from the university campus. After enrolment, muscle soreness will be experimentally induced, and then three groups of participants will be treated with four conventional approaches. Randomly allocated participants will get treatment from the outpatient service in the Physiotherapy and Rehabilitation Department of JUST. For this potential, researchers will follow Standard Protocol Items: Interventional Trials 2013 (SPIRIT) guidelines to maintain the quality of the interventional trial (Table 1 ) Table 1 Study protocol according to SPIRIT guideline Study Status DOMS induction program Participants (Execution) Preparation & Planning Training to team Piloting Enroll Study Time Baseline 0 24hr 48hr 72hr Intervention × × × × Enrollment × × × Informed consent × × × Eligibility × × × Evaluation PPT × × × × × 10cm VAS × × × × ROM × × × × × Abbreviations: DOMS: Delayed Onset of Muscle Soreness; hr: Hour; PPT: Pressure Pain Threshold; VAS: Visual Analog Scale; cm: Centimeter; ROM: Range of Motion; Sample size estimation Teare and colleagues [ 32 ] recommended that to establish the accuracy of the pooled standard deviation and for actual effect size, there is a minimum of 35 cases in each group of a randomised clinical trial. We will try to reach 120 samples, with a minimum of 40 samples for a group. Recruitment and Randomization The students of JUST will be the sample for the study. The participants will voluntarily be assigned and screened for eligibility from the JUST campus. After experimentally inducing DOMS, students will be randomly assigned for the group allocation. The participant will be assigned to one of the three groups using a sequential number of envelopes with a ratio of 1:1:1. The concealed allocation will be performed using the “Rand” function in Microsoft Excel 2019. Eligibility criteria The inclusion criteria of this study will be (1) People between 18 years to 30 years of age, (2) people who will participate voluntarily in the trial, and (3) healthy and physically fit males and females having DOMS within 24 hours. The exclusion criteria (1) Pregnancy, musculoskeletal disease, systemic neurological disease, cancer, mental illness, Drug addiction, allergy to the shockwave gel, cardiac illness, vascular disease of the limb or the CNS, regional scars, loss of sensation, history of surgery, fracture, infections. (2) People who have recently taken analgesics or NSAIDs (3) History of DOMS within the last week. Induction of Delayed onset of muscle soreness (DOMS) At baseline, DOMS of the non-dominant elbow flexors will be experimentally induced using a standardised exercise protocol [ 33 ]. The non-dominant biceps brachialis muscle will be selected to provoke DOMS (when an unaccustomed exercise is introduced). Every participant will sit at a bench and perform isolated biceps curls with a dumbbell. At first, every individual repetition maximum (1RM, i.e. the maximum weight lifted with one concentric contraction) will be determined for the elbow flexors by loading the dumbbell with free weights in 0.5 kg increments. Participants were encouraged verbally to exert their maximal effort. The 1RM will then be used to induce DOMS through eccentric contractions. For this, the experimenter lifted the dumbbell until the participant's elbow was fully flexed, and the subject lowered the weight eccentrically as slowly as possible until the elbow was fully extended. This procedure will continue until the participant’s subjective exhaustion. Study procedure After the trial registration, the researcher will start communicating with the students of JUST and estimate the population who agreed to participate in the trial voluntarily. Then, a specialised exercise program will be held to induce the delayed onset of muscle soreness (DOMS). After more than 12 hours of the exercise program, the participants who feel pain in their non-dominant elbow flexor muscle will account for the study population. Then, in a computer-based random serial, the first 120 people will be pooled for enrollment for 3 study groups. On the first day, an assessor blinded to group allocation will take a pre-test assessment. Then, the participant will be treated in three treatment approaches, and each group will receive either (1) rESWT with cryotherapy, (2) MFR with cryotherapy, or (3) stretching with cryotherapy. Every treatment will be provided immediately, 24, and 48 hours after DOMS induction. Then, measurements will be taken before DOMS induction and before and after every treatment session, and the final post-test will be measured after 72 hours. So, the measurements are pretest, then post-test-1 immediately after treatment, after 24 hours post-test 2, 48 post-test 3, and 72 hours post-test-4. Participants will be instructed not to exercise during this time. The primary outcome measurement will be Pain intensity at rest and movement, which will be assessed by a 10 cm visual analogue scale (VAS) and Pressure pain threshold (PPT) over the biceps muscle belly by pressure algometry and measure ROM inclinometer (active force-2). There will be a separate assessor for each of the treatment set-ups. If patients don’t take treatment after 1 or 2 sessions, they will be considered dropouts. The Consolidated Standards of Reporting Trials (CONSORT) manual will be followed when conducting the study. Study guideline The study will follow the CONSORT (Consolidated Standards of Reporting Trials) to maintain the standards of the study procedure (Fig. 1). Figure 1: CONSORT flow diagram Outcome measurement Primary outcome: Pain intensity Subjectively perceived muscle soreness at the elbow region during active movement of the biceps muscle will be assessed using a visual analogue scale VAS ranging from 0 to 10 cm (with 0 indicating no pain and 10 experiencing the worst imaginable pain) after the induction of DOMS and at 24, 48, and 72 hours following induction [ 34 ]. Pressure pain threshold (PPT) PPT will be assessed using a mechanical pressure algometer (Biotronix digital pressure algometer, Biotronix Care International, New Delhi, India) at some tender point in the muscle belly, musculotendinous junction of the biceps muscle. Pressure will be applied to each end with increasing force at approximately 1kg/cm2/s until the participants report a painful sensation and the force value is recorded (kg/cm2). An upper limit of PPT was set at 5kg/cm2 to avoid bruising. Each point was measured three times, with 10s intervals between trials, and the mean of the second and third trials will be used for the analysis. Secondary outcome: Measure the Joint pain-free active and passive ROM with the inclinometer (activeforce-2, dr. active, MedFac UK Ltd, United Kingdom). To use the inclinometer, the therapist holds the instrument on the patient, who begins in a standard starting position. The therapist zeroes out the inclinometer and then instructs the patient to bend the joint through its ROM. The inclinometer's final reading is the ROM measurement. Intervention All treatment will be performed by a graduate physiotherapist. Treatments will start immediately after the induction of DOMS, and all interventions will follow safety measures. Group − 1: radial Extracorporeal shockwave therapy (rESWT) with Cryotherapy rESWT will apply at different points of the bicep’s brachialis muscle including muscle belly and musculotendinous junction. The treatment session with rESWT (2.5 bars, 2000 pulses, 5Hz, 7minute) using the (Impactis M+, ASTAR) shockwave. In the treatment procedure, all patients will be lying in a supine position, elbow and shoulder respectively flexed at 90 0 and abducted at 45 0 with the forearm leaned on a plan, and shockwave applicators will position perpendicular to the site of the biceps muscle belly and myotendinous junction. The aqua sonic gel will be used at the application site for better contact with the skin and shockwave projectile head. Patients will receive one treatment session within 12 hours after the pretest [ 35 , 36 ]. The cryotherapy will be implemented alongside rESWT. This group will use an ice pack for 15 minutes in the muscle tender site of the biceps muscle [ 37 ]. Group − 2: Myofascial Release (MFR) with Cryotherapy The myofascial release technique will be held in the bicep’s brachialis muscle, where the average time to resolve densification is 5 min 1 repetition [ 38 ]. The therapist will locate the trigger or tender points in the bicep’s brachialis muscle during the MFR procedure. Then, he gently applies pressure for 30 to 45 seconds and continues for 3 to 4 minutes. The cryotherapy will be implemented alongside MFR. This group will use an ice pack for 15 minutes in the muscle tender site of the biceps muscle. Group 3: Stretching exercise with Cryotherapy Stretching of the biceps muscle will be held by the therapist passively. The therapist will position the participants in sitting and then pull the muscle for three sets of 17 stretching with a 10-second hold [ 39 ]. Cryotherapy will be implemented alongside stretching. This group will use an ice pack for 15 minutes in the muscle tender site of the biceps muscle. Statistical analysis Data will be analysed based on its nature. Calculation and data auditing will be done using Microsoft Excel 2016. Data will be analysed using SPSS version 23. Eligibility for parametric analysis will be checked using Bell’s curve, skewness, kurtosis, Kolmogorov–Simirniv test, and Shapiro–Wilk test. Continuous variables will be represented by using an arithmetic mean and standard deviation. Categorical data will be analysed by percentage (%) and frequency. The Pearson correlation for parametric data will check baseline compatibility and the chi-square test for non-parametric data. Between-group, post-test-1, post-test-2, post-test-3, and Post-test-4 variations among the groups will be assessed using MANOVA or the Multivariate Kruskal-Wallis (MKW) test, depending on the nature of the data. Three measures will be analysed within-group using an ANOVA [ 40 ], and additional post-hoc analyses will be performed using paired sample t-tests or Wilcoxon tests. We will perform the intention to treat the analysis process for the drop-out cases. In the case of a post hoc Bonferroni adjustment, the level of significance P < .05. Monitoring The monitoring team will include two people who are not directly working on this trial. They will take responsibility for monitoring the exercise-induced program, intervention protocol, adverse effects, and group enrollment of participants. They will also audit data and carry out any interim analysis. They will report changes in study methods and treatment to the Ethical Review Committee (ERC) via the principal investigator. Safety measures to avoid harmful effects Although it is desired that exercise-induced DOMS programs will not produce harmful effects on patients, the monitoring team will take note of any unexpected occurrences that do happen during or after the exercise program and intervention. They will principally inform the relevant specialists about them. Patients should be instructed to inform the physiotherapist if they feel any kind of discomfort after the program and intervention before the physiotherapist screens patients for any contraindications to intervention. If any harmful severe effects are found, researchers will report this during the final publication. Dissemination After the end of the trial, a research paper will be submitted to an indexed journal for publication of the original research. Besides the prosecution, a seminar will be conducted to share the results with relevant stakeholders. If the study results are found to be effective, a structured treatment protocol will also be organised. The trial results will be published as open access to ensure maximum visibility of the original research. Discussion Delayed onset of muscle soreness (DOMS) is a muscle injury. It occurs during unaccustomed eccentric muscle contraction or high-intensity exercise that manifests severe pain and limits the activity of a sportsperson or general people. Pain severity may exist for 6 to 7 days [ 41 ] and may start to mitigate independently. Sometimes, it can be treated with medication and physiotherapy treatment approaches. Moreover, we hypothesised that different physiotherapy treatment approaches affect pain mitigation and improved activity differently. Here, rESWT, MFR, cryotherapy, and stretching have different effects separately. Some studies suggested that MFR significantly affects muscle flexibility and helps reduce muscle soreness [ 30 ]. Cryotherapy and stretching also better impact pain reduction in DOMS. A study suggested that cryotherapy has a quick-fix effect on inflammation and pain reduction [ 42 ]. So, this study aims to compare the effectiveness of these approaches on exercise-induced DOMS. The study fills the research gap about the effectiveness of rESWT and compares MFR, stretching, and cryotherapy. Some studies have discussed the effectiveness of fESWT as significant [ 29 ], but there is a lack of evidence of the effectiveness of rESWT on DOMS. The result of the study will contribute to determining the appropriate comprehensive approach to reduce the severity of pain in DOMS. Also, this study can contribute to developing individual approaches efficacy to pain reduction and determine how early a player or patient overcomes their injury. The study will also determine treatment protocol for the early healing of muscle injury and cost-effective treatment for the athletes. Here, we will find which treatment approach is early practical for pain reduction and also associated with cost-effective treatment. Strength and limitations The strength of this study is its baseline data where the populations are young adults, and they attend the study voluntarily. The main thing is that the sample will be selected by voluntarily participating in an exercise-induced DOMS program where DOMS will induce a specific muscle by a specific exercise, which can help maintain the baseline injury severity and help to determine rigour evidence. The limitation of the study is that it only evaluates the effectiveness of rESWT on DOMS, but it would be better if rESWT were compared with focus extracorporeal shockwave therapy(fESWT). There are some challenges in this study; at first, the study will be self-funded, and the population of the study has to participate voluntarily. It will be very tough to sample collection. Also, there are some problems in that the study procedure of DOMS will be induced by exercise programs. There might be some ethical issues regarding participant health in this procedure. However, to overcome this conflict, we set our inclusion criteria, and a person who wants to participate voluntarily will be our sample. The author also takes ethical permission from the Ethical Review Committee (ERC), JUST. Trial Status The trial version number 1 and the version were formulated on January 1, 2024. The trial is not recruiting participants yet. Abbreviations rESWT: radial Extracorporeal Shockwave Therapy; DOMS: Delayed onset of muscle soreness; NSAID: Non-steroid anti-inflammatory drug; MFR: Myofascial release; RCT: Randomized Clinical Trial; VAS: Visual analog scale; PPT: Pressure pain threshold; ROM: Range of motion; MRI: Magnetic resonance imaging; CK: Creatine kinase; fESWT: Focused Extracorporeal Shockwave Therapy; JUST: Jashore University of Science and Technology; CONSORT: Consolidated standards of reporting trial; MANOVA: Multivariate analysis of variance; MKW: Multivariate Kruskal-Wallis; ANOVA: Analysis of variance; ERC: Ethical Review Committee; Declarations Ethical issues and informed consent According to ethical guidelines, the researchers will abide by the Helsinki Declaration. The participants' participation will be entirely voluntary, and they will have the right to withdraw from the trial at any time during the trial. The participants will be assured that participation in or withdrawal from the study will not cause any change to their regular treatment program. Participants will sign the informed consent. The Ethical Review Committee (ERC), Faculty of Biological Science and Technology, Jashore University of Science and Technology (JUST), provides ethical permission (Ref. REC/FBST/JUST/2023-167). The trial has been registered with the Clinical Trials Registry (CTRI/2023/08/056649). In case of any changes to the protocol, the research team will notify the Institutional Review Board, the trial registry platform, and the later publications. The personal information of the participants will be confidential and stored unanimously in a dataset at the Department of Physiotherapy and Rehabilitation at Jashore University of Science & Technology. Consent for Publication Not applicable. Competing interests The author declares no competing interests. Data availability Once the research has been completed, the data will be made freely available. The dataset analysed in the study will be made available from the corresponding author upon reasonable request. Funding The study will be self-funded. Author contribution AI, KMAH, and MZH contributed to conceptualising, planning, investigation, and administration. AI, KMAH, MFK, SJ, ER, MKH, and MZH also wrote the main manuscript text, established the supplemental files, and revised the manuscript. All authors have reviewed and approved the manuscripts. Acknowledgement The authors acknowledge the students of BPT 4th year of Jashore University of Science and Technology for their voluntary contribution to conceptualizing the study. References Heiss R, Lutter C, Freiwald J, Hoppe MW, Grim C, Poettgen K, Forst R, Bloch W, Hüttel M, Hotfiel T. 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Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014 Dec;15:1-3. Lau WY, Blazevich AJ, Newton MJ, Wu SS, Nosaka K. Assessment of muscle pain induced by elbow-flexor eccentric exercise. Journal of Athletic Training. 2015 Nov 1;50(11):1140-8. Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct 1;27(1):117-26. Walewicz K, Taradaj J, Dobrzyński M, Sopel M, Kowal M, Ptaszkowski K, Dymarek R. Effect of radial extracorporeal shock wave therapy on pain intensity, functional efficiency, and postural control parameters in patients with chronic low back pain: a randomized clinical trial. Journal of clinical medicine. 2020 Feb 19;9(2):568. Spacca G, Necozione S, Cacchio A. Radial shock wave therapy for lateral epicondylitis: a prospective randomised controlled single-blind study. Europa Medicophysica. 2005 Mar 1;41(1):17-25. Yackzan L, Adams C, Francis KT. The effects of ice massage on delayed muscle soreness. The American journal of sports medicine. 1984 Mar;12(2):159-65. Ajimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial. The Foot. 2014 Jun 1;24(2):66-71. Smith LL, Brunetz MH, Chenier TC, McCammon MR, Houmard JA, Franklin ME, Israel RG. The effects of static and ballistic stretching on delayed onset muscle soreness and creatine kinase. Research quarterly for exercise and sport. 1993 Mar 1;64(1):103-7. Kim HY. Analysis of variance (ANOVA) comparing means of more than two groups. Restorative dentistry & endodontics. 2014 Feb 1;39(1):74-7. Mizumura K, Taguchi T. Delayed onset muscle soreness: Involvement of neurotrophic factors. The journal of physiological sciences. 2016 Jan;66:43-52. Dupuy O, Douzi W, Theurot D, Bosquet L, Dugué B. An evidence-based approach for choosing post-exercise recovery techniques to reduce markers of muscle damage, soreness, fatigue, and inflammation: a systematic review with meta-analysis. Frontiers in physiology. 2018:403. Additional Declarations No competing interests reported. Supplementary Files SPIRITChecklist.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {\"props\":{\"pageProps\":{\"initialData\":{\"identity\":\"rs-4330620\",\"acceptedTermsAndConditions\":true,\"allowDirectSubmit\":true,\"archivedVersions\":[],\"articleType\":\"Study protocol\",\"associatedPublications\":[],\"authors\":[{\"id\":307733338,\"identity\":\"3a0fb7ee-9340-46be-a1d2-7ef69cd7759b\",\"order_by\":0,\"name\":\"Azharul Islam\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Jashore University of Science and Technology (JUST)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Azharul\",\"middleName\":\"\",\"lastName\":\"Islam\",\"suffix\":\"\"},{\"id\":307733339,\"identity\":\"b4951bb4-440f-43e2-91b1-30111018ade8\",\"order_by\":1,\"name\":\"K. M. Amran Hossain\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Jashore University of Science and Technology (JUST)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"K.\",\"middleName\":\"M. Amran\",\"lastName\":\"Hossain\",\"suffix\":\"\"},{\"id\":307733340,\"identity\":\"001e29b7-cf28-4dfc-a8c8-fa78f0f97336\",\"order_by\":2,\"name\":\"Md. Feroz Kabir\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Jashore University of Science and Technology (JUST)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Md.\",\"middleName\":\"Feroz\",\"lastName\":\"Kabir\",\"suffix\":\"\"},{\"id\":307733341,\"identity\":\"3671518a-25b6-4dc1-81c4-e2d945e44cb6\",\"order_by\":3,\"name\":\"Sharmila Jahan\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Jashore University of Science and Technology (JUST)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Sharmila\",\"middleName\":\"\",\"lastName\":\"Jahan\",\"suffix\":\"\"},{\"id\":307733342,\"identity\":\"51e20149-68d9-4e21-bae4-98f4527d9504\",\"order_by\":4,\"name\":\"Ehsanur Rahman\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Jashore University of Science and Technology (JUST)\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Ehsanur\",\"middleName\":\"\",\"lastName\":\"Rahman\",\"suffix\":\"\"},{\"id\":307733343,\"identity\":\"b7565831-3c2e-4f45-857d-e3065f425757\",\"order_by\":5,\"name\":\"Md. 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It is also determined as a grade-1 muscular injury in general, seen in recreational or amateur athletes [\\u003cspan citationid=\\\"CR3\\\" class=\\\"CitationRef\\\"\\u003e3\\u003c/span\\u003e]. Sometimes, DOMS appear after unaccustomed eccentric muscle contraction and unfamiliar exercise [\\u003cspan citationid=\\\"CR4\\\" class=\\\"CitationRef\\\"\\u003e4\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR5\\\" class=\\\"CitationRef\\\"\\u003e5\\u003c/span\\u003e]. Some studies suggested that isometric [\\u003cspan citationid=\\\"CR6\\\" class=\\\"CitationRef\\\"\\u003e6\\u003c/span\\u003e] and forceful concentric work cause a lesser extent of DOMS [\\u003cspan citationid=\\\"CR7\\\" class=\\\"CitationRef\\\"\\u003e7\\u003c/span\\u003e]. DOMS refers to the sensation of soreness, pain, stiffness, swelling, and reduced muscle function, which might impair the capacity for performance. The symptoms of DOMS have a regular progression from weakness and discomfort after exercise. The pain progresses after 24 hours; peak pain intensity is seen in 48 to 72 hours. The pain intensity is mitigated within 7 to 10 days after exercise [\\u003cspan citationid=\\\"CR8\\\" class=\\\"CitationRef\\\"\\u003e8\\u003c/span\\u003e]. In sports overload, skeletal muscle injuries are more common, and it describes incidence near about 10\\u0026ndash;55% of all sports-related injuries [\\u003cspan citationid=\\\"CR9\\\" class=\\\"CitationRef\\\"\\u003e9\\u003c/span\\u003e]. Though DOMS is not severe muscle damage, it usually causes a harmful impact and compromises sports performances. There is a lack of epidemiological evidence to demonstrate the overall view, as most of the time, DOMS remains undiagnosed and unassessed cases [\\u003cspan citationid=\\\"CR10\\\" class=\\\"CitationRef\\\"\\u003e10\\u003c/span\\u003e].\\u003c/p\\u003e \\u003cp\\u003eThere are several mechanisms by which DOMS can be described, such as muscle spasm, lactic acid formation, connective tissue and muscle damage, muscle inflammation, and enzyme efflux theory [\\u003cspan citationid=\\\"CR11\\\" class=\\\"CitationRef\\\"\\u003e11\\u003c/span\\u003e]. The most known mechanism of DOMS is lactic acid formation. It is the process where toxic metabolic waste products accumulate in the injury site, causing delayed pain sensation [\\u003cspan citationid=\\\"CR12\\\" class=\\\"CitationRef\\\"\\u003e12\\u003c/span\\u003e]. However, some studies describe other mechanisms of DOMS [\\u003cspan citationid=\\\"CR13\\\" class=\\\"CitationRef\\\"\\u003e13\\u003c/span\\u003e]. The muscle spasm theory describes that DOMS sensation is caused by an ischemic accumulation of metabolic waste products during exercise [\\u003cspan citationid=\\\"CR14\\\" class=\\\"CitationRef\\\"\\u003e14\\u003c/span\\u003e]. The inflammatory theory explains DOMS occurs through muscle responses to exhaustion as oedema formation, inflammatory cell infiltration, and temperature rises. These responses occur due to the degradation of the lipid and protein structure and the accumulation of different chemical mediators in the injury site, which leads to DOMS [\\u003cspan citationid=\\\"CR15\\\" class=\\\"CitationRef\\\"\\u003e15\\u003c/span\\u003e]. Enzyme efflux [\\u003cspan citationid=\\\"CR16\\\" class=\\\"CitationRef\\\"\\u003e16\\u003c/span\\u003e] and connective tissue theory also describe the DOMS mechanism.\\u003c/p\\u003e \\u003cp\\u003eDOMS can be identified or diagnosed in different ways. In general, by evaluating or examining the clinical signs and symptoms like 1) inspecting the muscle appearance, swelling, and colure, 2) muscle palpating, and 3) functional testing and pain measurement. These examinations must be held within 1 and 2 days after an unaccustomed eccentric exercise [\\u003cspan citationid=\\\"CR10\\\" class=\\\"CitationRef\\\"\\u003e10\\u003c/span\\u003e]. Several imaging methods have been used to assess the DOMS, including ultrasound, magnetic resonance imaging (MRI), and shear wave electrograph [\\u003cspan citationid=\\\"CR17\\\" class=\\\"CitationRef\\\"\\u003e17\\u003c/span\\u003e]. MRI and conventional ultrasound imaging analyse low to high-grade muscle damage and injury. Chemical and laboratory tests, such as creatine kinase (CK) activity level, are also used to diagnose muscle injury. [\\u003cspan citationid=\\\"CR10\\\" class=\\\"CitationRef\\\"\\u003e10\\u003c/span\\u003e] The proposed mechanism of DOMS needs proper treatment procedures to reduce pain intensity early, improve functional activity, or prevent further injury.\\u003c/p\\u003e \\u003cp\\u003eTreatment strategies can be administrated differently, like prophylactically for prevention purposes and conservative management, including Pain medication and Physiotherapy management for curative purposes. As a part of medical management for DOMS, Non-steroid anti-inflammatory (NSAID) drugs are widely used, e.g., diclofenac, naproxen, etc. Which helps reduce pain and inflammatory response [\\u003cspan citationid=\\\"CR18\\\" class=\\\"CitationRef\\\"\\u003e18\\u003c/span\\u003e]. However, in the case of a mild form of muscle injury, NSAIDs do not need to be used because a study suggests that NSAIDs have a negative effect on skeletal muscle regeneration as well as inhibit inflammatory responses [\\u003cspan citationid=\\\"CR19\\\" class=\\\"CitationRef\\\"\\u003e19\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR20\\\" class=\\\"CitationRef\\\"\\u003e20\\u003c/span\\u003e].In the treatment of DOMS, physiotherapy management is a better option than analgesics or NSAIDs [\\u003cspan citationid=\\\"CR21\\\" class=\\\"CitationRef\\\"\\u003e21\\u003c/span\\u003e]. For this circumstance, physiotherapy management for DOMS is a better option where various types of methods are used, like stretching, cryotherapy, myofascial release (MFR), extracorporeal shockwave therapy (ESWT), acupuncture, and compression [\\u003cspan citationid=\\\"CR22\\\" class=\\\"CitationRef\\\"\\u003e22\\u003c/span\\u003e]. Stretching is a therapeutic technique that promotes muscle extensibility, enhances flexibility, and lengthens tissue [\\u003cspan citationid=\\\"CR23\\\" class=\\\"CitationRef\\\"\\u003e23\\u003c/span\\u003e]. In DOMS, stretching helps to reduce muscle spasms by elongating muscle and increasing circulation on muscle. It is also used as a prophylactic method [\\u003cspan citationid=\\\"CR24\\\" class=\\\"CitationRef\\\"\\u003e24\\u003c/span\\u003e]. As conservative management, Cryotherapy is also used to manage acute pain and muscle injury. The use of cold on the injured side has an analgesic effect and reduces the signs of muscular damage. However, a study suggests a very mild impact on the perpetuation of muscle tenderness or strength deficit [\\u003cspan citationid=\\\"CR25\\\" class=\\\"CitationRef\\\"\\u003e25\\u003c/span\\u003e]. One study also describes the use of cryotherapy to improve soft tissue injury by reducing swelling, circulatory effect, and intravascular pressure [\\u003cspan citationid=\\\"CR26\\\" class=\\\"CitationRef\\\"\\u003e26\\u003c/span\\u003e] Myofascial release (MFR) helps to treat DOMS. This technique acts as a direct, gentle, sustained force for relaxation of the contracted muscle, improvement of venous and lymphatic circulation, and stimulation of stress reflexes [\\u003cspan citationid=\\\"CR27\\\" class=\\\"CitationRef\\\"\\u003e27\\u003c/span\\u003e].MFR also has a crucial role in reducing pain and soreness and improving muscle excitability. Evidence suggests that MFR also has a remarkable effect on muscle flexibility and helps to reduce exercise-induced muscle soreness [\\u003cspan citationid=\\\"CR28\\\" class=\\\"CitationRef\\\"\\u003e28\\u003c/span\\u003e] To reduce pain and inflammation in DOMS, shockwave therapy is another treatment approach. As a part of shockwave therapy-Focused extracorporeal shockwave therapy(fESWT) and radial extracorporeal shockwave therapy (rESWT) are widely used to treat muscle injury including tissue healing and pain reduction [\\u003cspan citationid=\\\"CR29\\\" class=\\\"CitationRef\\\"\\u003e29\\u003c/span\\u003e]. A study suggests that focused extracorporeal shockwave therapy significantly reduces pain intensity [\\u003cspan citationid=\\\"CR30\\\" class=\\\"CitationRef\\\"\\u003e30\\u003c/span\\u003e]. Besides, rESWT helps specifically to reduce musculotendinous pain and muscle triggers. A retrospective analysis describes that rESWT significantly improved in reducing grade 1 and grade 2 acute muscle injury [\\u003cspan citationid=\\\"CR31\\\" class=\\\"CitationRef\\\"\\u003e31\\u003c/span\\u003e]. However, there is no study to see the effectiveness of rESWT on exercise-induced DOMS, and there is also no clear evidence of rESWT compared with other treatment approaches, including MFR and Stretching. So, it is necessary to study the individual effects of rESWT, MFR, and Stretching and evaluate the combined implementation of these treatment approaches.\\u003c/p\\u003e \\u003cp\\u003eSo, the study aims to evaluate the effectiveness of rESWT, MFR, and stretching on exercise-induced DOMS as separate interventions along with cryotherapy and compare the effectiveness of these three approaches. The study's objectives are as follows: 1) To evaluate each group's sociodemographic status and baseline compatibility. 2) To find the effect of rESWT, MFR, and Stretching with cryotherapy on pain reduction in exercise-induced DOMS for biceps brachii muscle 3) To elicit the within-group differences of rESWT, MFR, and Stretching with cryotherapy to mitigation of pain in (immediate post-test-1),24hr post-test-2, 48hrs post-test 3, and 72 hours (post-test-4) compared to baseline and 4) To find out the effectiveness among groups (of rESWT, MFR, and Stretching with cryotherapy) and observations (pretest to post-test 4, pretest to post-test1, and post-test 1 to post-test 2, post-test 2 to post-test 3) comparison in the mitigation of pain and ROM.\\u003c/p\\u003e \\u003cp\\u003eThis study has two-tailed hypotheses: Using rESWT, MFR, and Cryotherapy to treat exercise-induced DOMS has different efficiencies in pain reduction and healing. Also, rESWT is more effective than MFR and Cryotherapy in pain remission.\\u003c/p\\u003e\"},{\"header\":\"Methods\",\"content\":\"\\u003cdiv id=\\\"Sec3\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eStudy design\\u003c/h2\\u003e \\u003cp\\u003eThe study will be an assessor- and patient-blinded Randomized Clinical Trial (RCT). It will investigate the effect of rESWT, MFR, and stretching with Cryotherapy on exercise-induced DOMS.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec4\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eStudy setting\\u003c/h2\\u003e \\u003cp\\u003eThe study will be conducted at Jashore University of Science and Technology (JUST), Jashore, Bangladesh. The participants will be recruited voluntarily from the university campus. After enrolment, muscle soreness will be experimentally induced, and then three groups of participants will be treated with four conventional approaches. Randomly allocated participants will get treatment from the outpatient service in the Physiotherapy and Rehabilitation Department of JUST.\\u003c/p\\u003e \\u003cp\\u003eFor this potential, researchers will follow Standard Protocol Items: Interventional Trials 2013 (SPIRIT) guidelines to maintain the quality of the interventional trial (Table\\u0026nbsp;\\u003cspan refid=\\\"Tab1\\\" class=\\\"InternalRef\\\"\\u003e1\\u003c/span\\u003e)\\u003c/p\\u003e \\u003cp\\u003e \\u003cdiv class=\\\"gridtable\\\"\\u003e\\u003ctable float=\\\"Yes\\\" id=\\\"Tab1\\\" border=\\\"1\\\"\\u003e \\u003ccaption language=\\\"En\\\"\\u003e \\u003cdiv class=\\\"CaptionNumber\\\"\\u003eTable 1\\u003c/div\\u003e \\u003cdiv class=\\\"CaptionContent\\\"\\u003e \\u003cp\\u003eStudy protocol according to SPIRIT guideline\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/caption\\u003e \\u003ccolgroup cols=\\\"9\\\"\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c1\\\" colnum=\\\"1\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c2\\\" colnum=\\\"2\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c3\\\" colnum=\\\"3\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c4\\\" colnum=\\\"4\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c5\\\" colnum=\\\"5\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c6\\\" colnum=\\\"6\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c7\\\" colnum=\\\"7\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c8\\\" colnum=\\\"8\\\"\\u003e\\u003c/div\\u003e \\u003cdiv align=\\\"left\\\" class=\\\"colspec\\\" colname=\\\"c9\\\" colnum=\\\"9\\\"\\u003e\\u003c/div\\u003e \\u003cthead\\u003e \\u003ctr\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c1\\\" morerows=\\\"1\\\" rowspan=\\\"2\\\"\\u003e \\u003cp\\u003eStudy Status\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colspan=\\\"3\\\" nameend=\\\"c4\\\" namest=\\\"c2\\\"\\u003e \\u003cp\\u003eDOMS induction program\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colspan=\\\"5\\\" nameend=\\\"c9\\\" namest=\\\"c5\\\"\\u003e \\u003cp\\u003eParticipants (Execution)\\u003c/p\\u003e \\u003c/th\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003ePreparation \\u0026amp; Planning\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003eTraining to team\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003ePiloting\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003eEnroll\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003eStudy\\u003c/p\\u003e \\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c7\\\"\\u003e\\u0026nbsp;\\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c8\\\"\\u003e\\u0026nbsp;\\u003c/th\\u003e \\u003cth align=\\\"left\\\" colname=\\\"c9\\\"\\u003e\\u0026nbsp;\\u003c/th\\u003e \\u003c/tr\\u003e \\u003c/thead\\u003e \\u003ctbody\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eTime\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003eBaseline 0\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e \\u003cp\\u003e24hr\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c8\\\"\\u003e \\u003cp\\u003e48hr\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c9\\\"\\u003e \\u003cp\\u003e72hr\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eIntervention\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c8\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c9\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eEnrollment\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c8\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c9\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eInformed consent\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c8\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c9\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eEligibility\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c8\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c9\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eEvaluation\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c8\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c9\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003ePPT\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c8\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c9\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003e10cm VAS\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c8\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c9\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c1\\\"\\u003e \\u003cp\\u003eROM\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c2\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c3\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c4\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c5\\\"\\u003e\\u0026nbsp;\\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c6\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c7\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c8\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003ctd align=\\\"left\\\" colname=\\\"c9\\\"\\u003e \\u003cp\\u003e\\u0026times;\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003ctr\\u003e \\u003ctd align=\\\"left\\\" colspan=\\\"9\\\" nameend=\\\"c9\\\" namest=\\\"c1\\\"\\u003e \\u003cp\\u003eAbbreviations: DOMS: Delayed Onset of Muscle Soreness; hr: Hour; PPT: Pressure Pain Threshold; VAS: Visual Analog Scale; cm: Centimeter; ROM: Range of Motion;\\u003c/p\\u003e \\u003c/td\\u003e \\u003c/tr\\u003e \\u003c/tbody\\u003e \\u003c/colgroup\\u003e \\u003c/table\\u003e\\u003c/div\\u003e \\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec5\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eSample size estimation\\u003c/h2\\u003e \\u003cp\\u003eTeare and colleagues [\\u003cspan citationid=\\\"CR32\\\" class=\\\"CitationRef\\\"\\u003e32\\u003c/span\\u003e] recommended that to establish the accuracy of the pooled standard deviation and for actual effect size, there is a minimum of 35 cases in each group of a randomised clinical trial. We will try to reach 120 samples, with a minimum of 40 samples for a group.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec6\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eRecruitment and Randomization\\u003c/h2\\u003e \\u003cp\\u003eThe students of JUST will be the sample for the study. The participants will voluntarily be assigned and screened for eligibility from the JUST campus. After experimentally inducing DOMS, students will be randomly assigned for the group allocation. The participant will be assigned to one of the three groups using a sequential number of envelopes with a ratio of 1:1:1. The concealed allocation will be performed using the \\u0026ldquo;Rand\\u0026rdquo; function in Microsoft Excel 2019.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec7\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eEligibility criteria\\u003c/h2\\u003e \\u003cp\\u003eThe inclusion criteria of this study will be (1) People between 18 years to 30 years of age, (2) people who will participate voluntarily in the trial, and (3) healthy and physically fit males and females having DOMS within 24 hours. The exclusion criteria (1) Pregnancy, musculoskeletal disease, systemic neurological disease, cancer, mental illness, Drug addiction, allergy to the shockwave gel, cardiac illness, vascular disease of the limb or the CNS, regional scars, loss of sensation, history of surgery, fracture, infections. (2) People who have recently taken analgesics or NSAIDs (3) History of DOMS within the last week.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec8\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eInduction of Delayed onset of muscle soreness (DOMS)\\u003c/h2\\u003e \\u003cp\\u003eAt baseline, DOMS of the non-dominant elbow flexors will be experimentally induced using a standardised exercise protocol [\\u003cspan citationid=\\\"CR33\\\" class=\\\"CitationRef\\\"\\u003e33\\u003c/span\\u003e]. The non-dominant biceps brachialis muscle will be selected to provoke DOMS (when an unaccustomed exercise is introduced). Every participant will sit at a bench and perform isolated biceps curls with a dumbbell. At first, every individual repetition maximum (1RM, i.e. the maximum weight lifted with one concentric contraction) will be determined for the elbow flexors by loading the dumbbell with free weights in 0.5 kg increments. Participants were encouraged verbally to exert their maximal effort. The 1RM will then be used to induce DOMS through eccentric contractions. For this, the experimenter lifted the dumbbell until the participant's elbow was fully flexed, and the subject lowered the weight eccentrically as slowly as possible until the elbow was fully extended. This procedure will continue until the participant\\u0026rsquo;s subjective exhaustion.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec9\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eStudy procedure\\u003c/h2\\u003e \\u003cp\\u003eAfter the trial registration, the researcher will start communicating with the students of JUST and estimate the population who agreed to participate in the trial voluntarily. Then, a specialised exercise program will be held to induce the delayed onset of muscle soreness (DOMS). After more than 12 hours of the exercise program, the participants who feel pain in their non-dominant elbow flexor muscle will account for the study population. Then, in a computer-based random serial, the first 120 people will be pooled for enrollment for 3 study groups. On the first day, an assessor blinded to group allocation will take a pre-test assessment. Then, the participant will be treated in three treatment approaches, and each group will receive either (1) rESWT with cryotherapy, (2) MFR with cryotherapy, or (3) stretching with cryotherapy. Every treatment will be provided immediately, 24, and 48 hours after DOMS induction. Then, measurements will be taken before DOMS induction and before and after every treatment session, and the final post-test will be measured after 72 hours. So, the measurements are pretest, then post-test-1 immediately after treatment, after 24 hours post-test 2, 48 post-test 3, and 72 hours post-test-4. Participants will be instructed not to exercise during this time. The primary outcome measurement will be Pain intensity at rest and movement, which will be assessed by a 10 cm visual analogue scale (VAS) and Pressure pain threshold (PPT) over the biceps muscle belly by pressure algometry and measure ROM inclinometer (active force-2). There will be a separate assessor for each of the treatment set-ups. If patients don\\u0026rsquo;t take treatment after 1 or 2 sessions, they will be considered dropouts. The Consolidated Standards of Reporting Trials (CONSORT) manual will be followed when conducting the study.\\u003c/p\\u003e \\u003cdiv id=\\\"Sec10\\\" class=\\\"Section3\\\"\\u003e \\u003ch2\\u003eStudy guideline\\u003c/h2\\u003e \\u003cp\\u003eThe study will follow the CONSORT (Consolidated Standards of Reporting Trials) to maintain the standards of the study procedure (Fig.\\u0026nbsp;1).\\u003c/p\\u003e \\u003cp\\u003eFigure 1: CONSORT flow diagram\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec11\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eOutcome measurement\\u003c/h2\\u003e \\u003cdiv id=\\\"Sec12\\\" class=\\\"Section3\\\"\\u003e \\u003ch2\\u003ePrimary outcome: Pain intensity\\u003c/h2\\u003e \\u003cp\\u003eSubjectively perceived muscle soreness at the elbow region during active movement of the biceps muscle will be assessed using a visual analogue scale VAS ranging from 0 to 10 cm (with 0 indicating no pain and 10 experiencing the worst imaginable pain) after the induction of DOMS and at 24, 48, and 72 hours following induction [\\u003cspan citationid=\\\"CR34\\\" class=\\\"CitationRef\\\"\\u003e34\\u003c/span\\u003e].\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec13\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003ePressure pain threshold (PPT)\\u003c/h2\\u003e \\u003cp\\u003ePPT will be assessed using a mechanical pressure algometer (Biotronix digital pressure algometer, Biotronix Care International, New Delhi, India) at some tender point in the muscle belly, musculotendinous junction of the biceps muscle. Pressure will be applied to each end with increasing force at approximately 1kg/cm2/s until the participants report a painful sensation and the force value is recorded (kg/cm2). An upper limit of PPT was set at 5kg/cm2 to avoid bruising. Each point was measured three times, with 10s intervals between trials, and the mean of the second and third trials will be used for the analysis.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec14\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eSecondary outcome:\\u003c/h2\\u003e \\u003cp\\u003eMeasure the Joint pain-free active and passive ROM with the inclinometer (activeforce-2, dr. active, MedFac UK Ltd, United Kingdom). To use the inclinometer, the therapist holds the instrument on the patient, who begins in a standard starting position. The therapist zeroes out the inclinometer and then instructs the patient to bend the joint through its ROM. The inclinometer's final reading is the ROM measurement.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec15\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eIntervention\\u003c/h2\\u003e \\u003cp\\u003eAll treatment will be performed by a graduate physiotherapist. Treatments will start immediately after the induction of DOMS, and all interventions will follow safety measures.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec16\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eGroup \\u0026minus;\\u0026thinsp;1: radial Extracorporeal shockwave therapy (rESWT) with Cryotherapy\\u003c/h2\\u003e \\u003cp\\u003erESWT will apply at different points of the bicep\\u0026rsquo;s brachialis muscle including muscle belly and musculotendinous junction. The treatment session with rESWT (2.5 bars, 2000 pulses, 5Hz, 7minute) using the (Impactis M+, ASTAR) shockwave. In the treatment procedure, all patients will be lying in a supine position, elbow and shoulder respectively flexed at 90\\u003csup\\u003e0\\u003c/sup\\u003e and abducted at 45\\u003csup\\u003e0\\u003c/sup\\u003e with the forearm leaned on a plan, and shockwave applicators will position perpendicular to the site of the biceps muscle belly and myotendinous junction. The aqua sonic gel will be used at the application site for better contact with the skin and shockwave projectile head. Patients will receive one treatment session within 12 hours after the pretest [\\u003cspan citationid=\\\"CR35\\\" class=\\\"CitationRef\\\"\\u003e35\\u003c/span\\u003e, \\u003cspan citationid=\\\"CR36\\\" class=\\\"CitationRef\\\"\\u003e36\\u003c/span\\u003e]. The cryotherapy will be implemented alongside rESWT. This group will use an ice pack for 15 minutes in the muscle tender site of the biceps muscle [\\u003cspan citationid=\\\"CR37\\\" class=\\\"CitationRef\\\"\\u003e37\\u003c/span\\u003e].\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec17\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eGroup \\u0026minus;\\u0026thinsp;2: Myofascial Release (MFR) with Cryotherapy\\u003c/h2\\u003e \\u003cp\\u003eThe myofascial release technique will be held in the bicep\\u0026rsquo;s brachialis muscle, where the average time to resolve densification is 5 min 1 repetition [\\u003cspan citationid=\\\"CR38\\\" class=\\\"CitationRef\\\"\\u003e38\\u003c/span\\u003e]. The therapist will locate the trigger or tender points in the bicep\\u0026rsquo;s brachialis muscle during the MFR procedure. Then, he gently applies pressure for 30 to 45 seconds and continues for 3 to 4 minutes. The cryotherapy will be implemented alongside MFR. This group will use an ice pack for 15 minutes in the muscle tender site of the biceps muscle.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec18\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eGroup 3: Stretching exercise with Cryotherapy\\u003c/h2\\u003e \\u003cp\\u003eStretching of the biceps muscle will be held by the therapist passively. The therapist will position the participants in sitting and then pull the muscle for three sets of 17 stretching with a 10-second hold [\\u003cspan citationid=\\\"CR39\\\" class=\\\"CitationRef\\\"\\u003e39\\u003c/span\\u003e]. Cryotherapy will be implemented alongside stretching. This group will use an ice pack for 15 minutes in the muscle tender site of the biceps muscle.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec19\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eStatistical analysis\\u003c/h2\\u003e \\u003cp\\u003eData will be analysed based on its nature. Calculation and data auditing will be done using Microsoft Excel 2016. Data will be analysed using SPSS version 23. Eligibility for parametric analysis will be checked using Bell\\u0026rsquo;s curve, skewness, kurtosis, Kolmogorov\\u0026ndash;Simirniv test, and Shapiro\\u0026ndash;Wilk test. Continuous variables will be represented by using an arithmetic mean and standard deviation. Categorical data will be analysed by percentage (%) and frequency. The Pearson correlation for parametric data will check baseline compatibility and the chi-square test for non-parametric data. Between-group, post-test-1, post-test-2, post-test-3, and Post-test-4 variations among the groups will be assessed using MANOVA or the Multivariate Kruskal-Wallis (MKW) test, depending on the nature of the data. Three measures will be analysed within-group using an ANOVA [\\u003cspan citationid=\\\"CR40\\\" class=\\\"CitationRef\\\"\\u003e40\\u003c/span\\u003e], and additional post-hoc analyses will be performed using paired sample t-tests or Wilcoxon tests. We will perform the intention to treat the analysis process for the drop-out cases. In the case of a post hoc Bonferroni adjustment, the level of significance P\\u0026thinsp;\\u0026lt;\\u0026thinsp;.05.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec20\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eMonitoring\\u003c/h2\\u003e \\u003cp\\u003eThe monitoring team will include two people who are not directly working on this trial. They will take responsibility for monitoring the exercise-induced program, intervention protocol, adverse effects, and group enrollment of participants. They will also audit data and carry out any interim analysis. They will report changes in study methods and treatment to the Ethical Review Committee (ERC) via the principal investigator.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec21\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eSafety measures to avoid harmful effects\\u003c/h2\\u003e \\u003cp\\u003eAlthough it is desired that exercise-induced DOMS programs will not produce harmful effects on patients, the monitoring team will take note of any unexpected occurrences that do happen during or after the exercise program and intervention. They will principally inform the relevant specialists about them. Patients should be instructed to inform the physiotherapist if they feel any kind of discomfort after the program and intervention before the physiotherapist screens patients for any contraindications to intervention. If any harmful severe effects are found, researchers will report this during the final publication.\\u003c/p\\u003e \\u003c/div\\u003e \\u003cdiv id=\\\"Sec22\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eDissemination\\u003c/h2\\u003e \\u003cp\\u003eAfter the end of the trial, a research paper will be submitted to an indexed journal for publication of the original research. Besides the prosecution, a seminar will be conducted to share the results with relevant stakeholders. If the study results are found to be effective, a structured treatment protocol will also be organised. The trial results will be published as open access to ensure maximum visibility of the original research.\\u003c/p\\u003e \\u003c/div\\u003e\"},{\"header\":\"Discussion\",\"content\":\"\\u003cp\\u003eDelayed onset of muscle soreness (DOMS) is a muscle injury. It occurs during unaccustomed eccentric muscle contraction or high-intensity exercise that manifests severe pain and limits the activity of a sportsperson or general people. Pain severity may exist for 6 to 7 days [\\u003cspan citationid=\\\"CR41\\\" class=\\\"CitationRef\\\"\\u003e41\\u003c/span\\u003e] and may start to mitigate independently. Sometimes, it can be treated with medication and physiotherapy treatment approaches.\\u003c/p\\u003e \\u003cp\\u003eMoreover, we hypothesised that different physiotherapy treatment approaches affect pain mitigation and improved activity differently. Here, rESWT, MFR, cryotherapy, and stretching have different effects separately. Some studies suggested that MFR significantly affects muscle flexibility and helps reduce muscle soreness [\\u003cspan citationid=\\\"CR30\\\" class=\\\"CitationRef\\\"\\u003e30\\u003c/span\\u003e]. Cryotherapy and stretching also better impact pain reduction in DOMS. A study suggested that cryotherapy has a quick-fix effect on inflammation and pain reduction [\\u003cspan citationid=\\\"CR42\\\" class=\\\"CitationRef\\\"\\u003e42\\u003c/span\\u003e]. So, this study aims to compare the effectiveness of these approaches on exercise-induced DOMS.\\u003c/p\\u003e \\u003cp\\u003eThe study fills the research gap about the effectiveness of rESWT and compares MFR, stretching, and cryotherapy. Some studies have discussed the effectiveness of fESWT as significant [\\u003cspan citationid=\\\"CR29\\\" class=\\\"CitationRef\\\"\\u003e29\\u003c/span\\u003e], but there is a lack of evidence of the effectiveness of rESWT on DOMS.\\u003c/p\\u003e \\u003cp\\u003eThe result of the study will contribute to determining the appropriate comprehensive approach to reduce the severity of pain in DOMS. Also, this study can contribute to developing individual approaches efficacy to pain reduction and determine how early a player or patient overcomes their injury. The study will also determine treatment protocol for the early healing of muscle injury and cost-effective treatment for the athletes. Here, we will find which treatment approach is early practical for pain reduction and also associated with cost-effective treatment.\\u003c/p\\u003e \\u003cdiv id=\\\"Sec24\\\" class=\\\"Section2\\\"\\u003e \\u003ch2\\u003eStrength and limitations\\u003c/h2\\u003e \\u003cp\\u003eThe strength of this study is its baseline data where the populations are young adults, and they attend the study voluntarily. The main thing is that the sample will be selected by voluntarily participating in an exercise-induced DOMS program where DOMS will induce a specific muscle by a specific exercise, which can help maintain the baseline injury severity and help to determine rigour evidence. The limitation of the study is that it only evaluates the effectiveness of rESWT on DOMS, but it would be better if rESWT were compared with focus extracorporeal shockwave therapy(fESWT). There are some challenges in this study; at first, the study will be self-funded, and the population of the study has to participate voluntarily. It will be very tough to sample collection. Also, there are some problems in that the study procedure of DOMS will be induced by exercise programs. There might be some ethical issues regarding participant health in this procedure. However, to overcome this conflict, we set our inclusion criteria, and a person who wants to participate voluntarily will be our sample. The author also takes ethical permission from the Ethical Review Committee (ERC), JUST.\\u003c/p\\u003e \\u003cdiv id=\\\"Sec25\\\" class=\\\"Section3\\\"\\u003e \\u003ch2\\u003eTrial Status\\u003c/h2\\u003e \\u003cp\\u003eThe trial version number 1 and the version were formulated on January 1, 2024. The trial is not recruiting participants yet.\\u003c/p\\u003e \\u003c/div\\u003e \\u003c/div\\u003e\"},{\"header\":\"Abbreviations\",\"content\":\"\\u003cp\\u003erESWT: radial Extracorporeal Shockwave Therapy; DOMS: Delayed onset of muscle \\u0026nbsp;soreness; NSAID: Non-steroid anti-inflammatory drug; MFR: Myofascial release; RCT: Randomized Clinical Trial; VAS: Visual analog scale; PPT: Pressure pain threshold; ROM: Range of motion; MRI: Magnetic resonance imaging; CK: Creatine kinase; fESWT: Focused Extracorporeal Shockwave Therapy; JUST: Jashore University of Science and Technology; CONSORT: Consolidated standards of reporting trial; MANOVA: Multivariate analysis of variance; MKW: Multivariate Kruskal-Wallis; ANOVA: Analysis of variance; ERC: Ethical Review Committee;\\u003c/p\\u003e\\n\"},{\"header\":\"Declarations\",\"content\":\"\\u003cp\\u003e\\u003cstrong\\u003e\\u003cem\\u003eEthical issues and informed consent\\u003c/em\\u003e\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eAccording to ethical guidelines, the researchers will abide by the Helsinki Declaration. The participants\\u0026apos; participation will be entirely voluntary, and they will have the right to withdraw from the trial at any time during the trial. The participants will be assured that participation in or withdrawal from the study will not cause any change to their regular treatment program. Participants will sign the informed consent. The Ethical Review Committee (ERC), Faculty of Biological Science and Technology, Jashore University of Science and Technology (JUST), provides ethical permission (Ref. REC/FBST/JUST/2023-167). The trial has been registered with the Clinical Trials Registry (CTRI/2023/08/056649). In case of any changes to the protocol, the research team will notify the Institutional Review Board, the trial registry platform, and the later publications. The personal information of the participants will be confidential and stored unanimously in a dataset at the Department of Physiotherapy and Rehabilitation at Jashore University of Science \\u0026amp; Technology.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u0026nbsp;\\u003cstrong\\u003e\\u003cem\\u003eConsent for Publication\\u003c/em\\u003e\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eNot applicable.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u0026nbsp;\\u003cstrong\\u003e\\u003cem\\u003eCompeting interests\\u003c/em\\u003e\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe author declares no competing interests.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u003cstrong\\u003e\\u0026nbsp;\\u003c/strong\\u003e\\u003cstrong\\u003e\\u003cem\\u003eData availability\\u003c/em\\u003e\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eOnce the research has been completed, the data will be made freely available. The dataset analysed in the study will be made available from the corresponding author upon reasonable request.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u0026nbsp;\\u003cstrong\\u003e\\u003cem\\u003eFunding\\u003c/em\\u003e\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe study will be self-funded.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u0026nbsp;\\u003cstrong\\u003e\\u003cem\\u003eAuthor contribution\\u003c/em\\u003e\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eAI, KMAH, and MZH contributed to conceptualising, planning, investigation, and\\u0026nbsp;administration.\\u0026nbsp;AI, KMAH, MFK, SJ, ER, MKH, and MZH also wrote the main manuscript text, established the supplemental files, and revised the manuscript. All authors have reviewed and approved the manuscripts.\\u003c/p\\u003e\\n\\u003cp\\u003e\\u0026nbsp;\\u003cstrong\\u003e\\u003cem\\u003eAcknowledgement\\u003c/em\\u003e\\u003c/strong\\u003e\\u003c/p\\u003e\\n\\u003cp\\u003eThe authors acknowledge the students of BPT 4th year of Jashore University of Science and Technology for their voluntary contribution to conceptualizing the study.\\u003c/p\\u003e\"},{\"header\":\"References\",\"content\":\"\\u003col\\u003e\\n\\u003cli\\u003eHeiss R, Lutter C, Freiwald J, Hoppe MW, Grim C, Poettgen K, Forst R, Bloch W, H\\u0026uuml;ttel M, Hotfiel T. Advances in delayed-onset muscle soreness (DOMS)\\u0026ndash;part II: treatment and prevention. Sportverletzung\\u0026middot; Sportschaden. 2019 Mar;33(01):21-9.\\u003c/li\\u003e\\n\\u003cli\\u003eMacIntyre DL, Reid WD, McKenzie DC. Delayed muscle soreness: the inflammatory response to muscle injury and its clinical implications. Sports medicine. 1995 Jul;20:24-40.\\u003c/li\\u003e\\n\\u003cli\\u003eGulick DT, Kimura IF. Delayed onset muscle soreness: what is it and how do we treat it?. Journal of Sport Rehabilitation. 1996 Aug 1;5(3):234-43.\\u003c/li\\u003e\\n\\u003cli\\u003eFleckenstein J, Friton M, Himmelreich H, Banzer W. Effect of a single administration of focused extracorporeal shock wave in the relief of delayed-onset muscle soreness: results of a partially blinded randomized controlled trial. Archives of physical medicine and rehabilitation. 2017 May 1;98(5):923-30.\\u003c/li\\u003e\\n\\u003cli\\u003eArmstrong RB. Initial events in exercise-induced muscular injury. Medicine and science in sports and exercise. 1990 Aug 1;22(4):429-35.\\u003c/li\\u003e\\n\\u003cli\\u003eKlimek A. Physiological background of muscular pain during skiing and delayed muscle soreness after skiing. Journal of Human Kinetics. 2010 Jan 1;23(2010):55-61.\\u003c/li\\u003e\\n\\u003cli\\u003eAsmussen E. Observations on experimental muscular soreness. Acta Rheumatologica Scandinavica. 1956 Dec 1;2(1-4):109-16.\\u003c/li\\u003e\\n\\u003cli\\u003eH\\u0026uuml;bscher M, Vogt L, Bernh\\u0026ouml;rster M, Rosenhagen A, Banzer W. Effects of acupuncture on symptoms and muscle function in delayed-onset muscle soreness. The Journal of Alternative and Complementary Medicine. 2008 Oct 1;14(8):1011-6.\\u003c/li\\u003e\\n\\u003cli\\u003eBarroso GC, Thiele ES. Muscle injuries in athletes. Revista brasileira de ortopedia. 2011;46:354-8.\\u003c/li\\u003e\\n\\u003cli\\u003eHotfiel T, Freiwald J, Hoppe MW, Lutter C, Forst R, Grim C, Bloch W, H\\u0026uuml;ttel M, Heiss R. Advances in delayed-onset muscle soreness (DOMS): Part I: Pathogenesis and diagnostics. Sportverletzung\\u0026middot; Sportschaden. 2018 Dec;32(04):243-50.\\u003c/li\\u003e\\n\\u003cli\\u003eCleak MJ, Eston RG. Delayed onset muscle soreness: mechanisms and management. 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Canadian journal of sport sciences= Journal canadien des sciences du sport. 1992 Mar 1;17(1):8-13.\\u003c/li\\u003e\\n\\u003cli\\u003eDelayed onset muscle soreness [Internet]. Wikimedia Foundation; 2023 [cited 2023 Aug 27]. Available from: https://en.wikipedia.org/wiki/Delayed_onset_muscle_soreness#:~:text=Another%20explanation%20for%20the%20pain,accumulates%20in%20the%20damaged%20muscles. \\u003c/li\\u003e\\n\\u003cli\\u003eJadamba T, Bor A, Tsendjav T. S82 Ultrasound in Medicine \\u0026amp; Biology Volume 45, Number S1, 2019. Ultrasound in Medicine \\u0026amp; Biology. 2019;45(S1).\\u003c/li\\u003e\\n\\u003cli\\u003eCornu C, Grange C, Regalin A, Munier J, Ounissi S, Reynaud N, Kassai-Koupai B, Sallet P, Nony P. Effect of non-steroidal anti-inflammatory drugs on sport performance indices in healthy people: a meta-analysis of randomized controlled trials. Sports Medicine-Open. 2020 Dec;6:1-1.\\u003c/li\\u003e\\n\\u003cli\\u003ePaulsen G, Ramer Mikkelsen U, Raastad T, Peake JM. Leucocytes, cytokines and satellite cells: what role do they play in muscle damage and regeneration following eccentric exercise?. Exercise immunology review. 2012 Jan 1;18.\\u003c/li\\u003e\\n\\u003cli\\u003eSchoenfeld BJ. The use of nonsteroidal anti-inflammatory drugs for exercise-induced muscle damage: implications for skeletal muscle development. Sports medicine. 2012 Dec;42:1017-28.\\u003c/li\\u003e\\n\\u003cli\\u003eCheung K, Hume PA, Maxwell L. Delayed onset muscle soreness. Sports medicine. 2003 Feb;33(2):145-64.\\u003c/li\\u003e\\n\\u003cli\\u003eNahon RL, Lopes JS, de Magalh\\u0026atilde;es Neto AM. Physical therapy interventions for the treatment of delayed onset muscle soreness (DOMS): Systematic review and meta-analysis. Physical Therapy in Sport. 2021 Nov 1;52:1-2.\\u003c/li\\u003e\\n\\u003cli\\u003eShellock FG, Prentice WE. Warming-up and stretching for improved physical performance and prevention of sports-related injuries. Sports medicine. 1985 Jul;2:267-78.\\u003c/li\\u003e\\n\\u003cli\\u003eBobbert MF, Hollander AP, Huijing PA. Factors in delayed onset muscular soreness of man. Medicine and Science in Sports and Exercise. 1986 Feb 1;18(1):75-81.\\u003c/li\\u003e\\n\\u003cli\\u003eEston R, Peters D. Effects of cold water immersion on the symptoms of exercise-induced muscle damage. Journal of sports sciences. 1999 Jan 1;17(3):231-8.\\u003c/li\\u003e\\n\\u003cli\\u003eBierman W. Therapeutic use of cold. Journal of the American medical association. 1955 Apr 2;157(14):1189-92.\\u003c/li\\u003e\\n\\u003cli\\u003eBoyajian-O\\u0026rsquo;Neill LA, Cardone DA. Practical application of osteopathic manipulation in Sports Medicine. The Sports Medicine Resource Manual. 2008;437\\u0026ndash;43. doi:10.1016/b978-141603197-0.10034-5\\u003c/li\\u003e\\n\\u003cli\\u003ePanwar D, Sen S. Immediate Effects of Myofascial Release Technique on Muscle Flexibility, Vertical Jump Height in Recreational Badminton Players. Journal of Clinical \\u0026amp; Diagnostic Research. 2021 May 1;15(5).\\u003c/li\\u003e\\n\\u003cli\\u003eSpeed C. A systematic review of shockwave therapies in soft tissue conditions: focusing on the evidence. British journal of sports medicine. 2014 Nov 1;48(21):1538-42.\\u003c/li\\u003e\\n\\u003cli\\u003eFleckenstein J, Friton M, Himmelreich H, Banzer W. Effect of a single administration of focused extracorporeal shock wave in the relief of delayed-onset muscle soreness: results of a partially blinded randomized controlled trial. Archives of physical medicine and rehabilitation. 2017 May 1;98(5):923-30.\\u003c/li\\u003e\\n\\u003cli\\u003eMorgan JP, Hamm M, Schmitz C, Brem MH. Return to play after treating acute muscle injuries in elite football players with radial extracorporeal shock wave therapy. Journal of Orthopaedic Surgery and Research. 2021 Dec;16:1-1.\\u003c/li\\u003e\\n\\u003cli\\u003eTeare MD, Dimairo M, Shephard N, Hayman A, Whitehead A, Walters SJ. Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study. Trials. 2014 Dec;15:1-3.\\u003c/li\\u003e\\n\\u003cli\\u003eLau WY, Blazevich AJ, Newton MJ, Wu SS, Nosaka K. Assessment of muscle pain induced by elbow-flexor eccentric exercise. Journal of Athletic Training. 2015 Nov 1;50(11):1140-8.\\u003c/li\\u003e\\n\\u003cli\\u003eJensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct 1;27(1):117-26.\\u003c/li\\u003e\\n\\u003cli\\u003eWalewicz K, Taradaj J, Dobrzyński M, Sopel M, Kowal M, Ptaszkowski K, Dymarek R. Effect of radial extracorporeal shock wave therapy on pain intensity, functional efficiency, and postural control parameters in patients with chronic low back pain: a randomized clinical trial. Journal of clinical medicine. 2020 Feb 19;9(2):568.\\u003c/li\\u003e\\n\\u003cli\\u003eSpacca G, Necozione S, Cacchio A. Radial shock wave therapy for lateral epicondylitis: a prospective randomised controlled single-blind study. Europa Medicophysica. 2005 Mar 1;41(1):17-25.\\u003c/li\\u003e\\n\\u003cli\\u003eYackzan L, Adams C, Francis KT. The effects of ice massage on delayed muscle soreness. The American journal of sports medicine. 1984 Mar;12(2):159-65.\\u003c/li\\u003e\\n\\u003cli\\u003eAjimsha MS, Binsu D, Chithra S. Effectiveness of myofascial release in the management of plantar heel pain: a randomized controlled trial. The Foot. 2014 Jun 1;24(2):66-71.\\u003c/li\\u003e\\n\\u003cli\\u003eSmith LL, Brunetz MH, Chenier TC, McCammon MR, Houmard JA, Franklin ME, Israel RG. The effects of static and ballistic stretching on delayed onset muscle soreness and creatine kinase. Research quarterly for exercise and sport. 1993 Mar 1;64(1):103-7.\\u003c/li\\u003e\\n\\u003cli\\u003eKim HY. Analysis of variance (ANOVA) comparing means of more than two groups. Restorative dentistry \\u0026amp; endodontics. 2014 Feb 1;39(1):74-7.\\u003c/li\\u003e\\n\\u003cli\\u003eMizumura K, Taguchi T. Delayed onset muscle soreness: Involvement of neurotrophic factors. The journal of physiological sciences. 2016 Jan;66:43-52.\\u003c/li\\u003e\\n\\u003cli\\u003eDupuy O, Douzi W, Theurot D, Bosquet L, Dugu\\u0026eacute; B. An evidence-based approach for choosing post-exercise recovery techniques to reduce markers of muscle damage, soreness, fatigue, and inflammation: a systematic review with meta-analysis. Frontiers in physiology. 2018:403.\\u003c/li\\u003e\\n\\u003c/ol\\u003e\"}],\"fulltextSource\":\"\",\"fullText\":\"\",\"funders\":[],\"hasAdminPriorityOnWorkflow\":false,\"hasManuscriptDocX\":true,\"hasOptedInToPreprint\":true,\"hasPassedJournalQc\":\"\",\"hasAnyPriority\":false,\"hideJournal\":true,\"highlight\":\"\",\"institution\":\"\",\"isAcceptedByJournal\":false,\"isAuthorSuppliedPdf\":false,\"isDeskRejected\":\"\",\"isHiddenFromSearch\":false,\"isInQc\":false,\"isInWorkflow\":false,\"isPdf\":false,\"isPdfUpToDate\":true,\"isWithdrawnOrRetracted\":false,\"journal\":{\"display\":true,\"email\":\"info@researchsquare.com\",\"identity\":\"researchsquare\",\"isNatureJournal\":false,\"hasQc\":true,\"allowDirectSubmit\":true,\"externalIdentity\":\"\",\"sideBox\":\"\",\"snPcode\":\"\",\"submissionUrl\":\"/submission\",\"title\":\"Research Square\",\"twitterHandle\":\"researchsquare\",\"acdcEnabled\":true,\"dfaEnabled\":false,\"editorialSystem\":\"\",\"reportingPortfolio\":\"\",\"inReviewEnabled\":false,\"inReviewRevisionsEnabled\":true},\"keywords\":\"Muscle Soreness, Myofascial release, Cryotherapy, Extracorporeal Shockwave therapy\",\"lastPublishedDoi\":\"10.21203/rs.3.rs-4330620/v1\",\"lastPublishedDoiUrl\":\"https://doi.org/10.21203/rs.3.rs-4330620/v1\",\"license\":{\"name\":\"CC BY 4.0\",\"url\":\"https://creativecommons.org/licenses/by/4.0/\"},\"manuscriptAbstract\":\"\\u003ch2\\u003eBackground\\u003c/h2\\u003e \\u003cp\\u003eDelayed onset of muscle soreness (DOMS) is a typical physiological response to unaccustomed to intense exercise, characterised by pain, stiffness, and reduced muscle function. DOMS is often experienced in muscles after strenuous limb activities, impacting an individual's physical performance and overall well-being. Effective management strategies for DOMS are essential to minimise discomfort and enhance recovery. In the treatment of DOMS, physiotherapy management is a better option rather than analgesics or NSAIDs. There is a research gap on radial extracorporeal shockwave therapy, rESWT, MFR, cryotherapy, etc. that has an individual and unique effect on pain reduction and functional improvement.\\u003c/p\\u003e\\u003ch2\\u003eMethod\\u003c/h2\\u003e \\u003cp\\u003eAn assessor and participants-blinded randomised clinical trial (RCT) will be used for the investigation. The impact of rESWT, MFR, and stretching combined with cryotherapy on exercise-induced DOMS will be examined in this study. On the patient, DOMS will be induced for research purposes. Three groups will receive rESWT, MFR, and stretching in addition to cryotherapy. After DOMS is induced, the treatment will be given once daily for 0 to 48 hours (3 times in 3 days). Each group will include 40 students, and the research will measure how rESWT, MFR, Cryotherapy, and Stretching affect pain alleviation before treatment (pretest), immediately after treatment (post-test 1), 24 hours later (post-test 2), 48 hours later (post-test 3) and 72 hours later (post-test 4). The outcome metric will be pain intensity and ROM. Male and female students of the University with good physical health and without a history of taking painkillers recently make up the study\\u0026rsquo;s groups.\\u003c/p\\u003e\\u003ch2\\u003eDiscussion\\u003c/h2\\u003e \\u003cp\\u003eThe study investigates the efficacy of physiotherapy approaches (rESWT, MFR, Cryotherapy, and Stretching) on exercise-induced DOMS. It addresses a research gap regarding rESWT\\u0026rsquo;s effectiveness and offers valuable insights into pain reduction methods. The findings can guide comprehensive pain management and individualised recovery strategies.\\u003c/p\\u003e\\u003ch2\\u003eTrial registration\\u003c/h2\\u003e \\u003cp\\u003eCTRI/2023/08/056649 [Registered on: 18/08/2023]\\u003c/p\\u003e\",\"manuscriptTitle\":\"Comparing the effectiveness of radial Extracorporeal Shockwave therapy (rESWT) and three conventional treatment approaches for biceps brachii muscle in exercise-induced Delayed Onset of Muscle Soreness (DOMS): A Protocol for a Randomized Clinical Trial\",\"msid\":\"\",\"msnumber\":\"\",\"nonDraftVersions\":[{\"code\":1,\"date\":\"2024-06-04 21:56:54\",\"doi\":\"10.21203/rs.3.rs-4330620/v1\",\"editorialEvents\":[{\"type\":\"communityComments\",\"content\":0}],\"status\":\"published\",\"journal\":{\"display\":true,\"email\":\"info@researchsquare.com\",\"identity\":\"researchsquare\",\"isNatureJournal\":false,\"hasQc\":true,\"allowDirectSubmit\":true,\"externalIdentity\":\"\",\"sideBox\":\"\",\"snPcode\":\"\",\"submissionUrl\":\"/submission\",\"title\":\"Research Square\",\"twitterHandle\":\"researchsquare\",\"acdcEnabled\":true,\"dfaEnabled\":false,\"editorialSystem\":\"\",\"reportingPortfolio\":\"\",\"inReviewEnabled\":false,\"inReviewRevisionsEnabled\":true}}],\"origin\":\"\",\"ownerIdentity\":\"c3d6d648-bf7e-48ae-8292-cb5cf8ae0bfe\",\"owner\":[],\"postedDate\":\"June 4th, 2024\",\"published\":true,\"recentEditorialEvents\":[],\"rejectedJournal\":[],\"revision\":\"\",\"amendment\":\"\",\"status\":\"posted\",\"subjectAreas\":[],\"tags\":[],\"updatedAt\":\"2024-08-09T15:01:58+00:00\",\"versionOfRecord\":[],\"versionCreatedAt\":\"2024-06-04 21:56:54\",\"video\":\"\",\"vorDoi\":\"\",\"vorDoiUrl\":\"\",\"workflowStages\":[]},\"version\":\"v1\",\"identity\":\"rs-4330620\",\"journalConfig\":\"researchsquare\"},\"__N_SSP\":true},\"page\":\"/article/[identity]/[[...version]]\",\"query\":{\"redirect\":\"/article/rs-4330620\",\"identity\":\"rs-4330620\",\"version\":[\"v1\"]},\"buildId\":\"8U1c8b4HqxoKbykW_rLl7\",\"isFallback\":false,\"isExperimentalCompile\":false,\"dynamicIds\":[84888],\"gssp\":true,\"scriptLoader\":[]}","source_license":"CC-BY-4.0","license_restricted":false}