Synergistic effect of local corticosteroid injection(LCI) with extracorporeal shock wave therapy(ESWT) in the treatment of patients with mild to moderate carpal tunnel syndrome(CTS): A Randomized Controlled Trial

Synergistic effect of local corticosteroid injection(LCI) with extracorporeal shock wave therapy(ESWT) in the treatment of patients with mild to moderate carpal tunnel syndrome(CTS): A Randomized Controlled 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 Research Article Synergistic effect of local corticosteroid injection(LCI) with extracorporeal shock wave therapy(ESWT) in the treatment of patients with mild to moderate carpal tunnel syndrome(CTS): A Randomized Controlled Trial morteza gholipour, sona bonakdar, mona gorji, reza minaei This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-2652602/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 01 Jul, 2023 Read the published version in Journal of Orthopaedic Surgery and Research → Version 1 posted 12 You are reading this latest preprint version Abstract Background: Applying extracorporeal shock wave therapy (ESWT) injection in carpal tunnel syndrome (CTS) management is gaining momentum. The objective is to actualize the topic of this study. Methods: In this prospective randomized controlled trial, forty patients with mild to moderate CTS are divided into two sham-ESWT and ESWL groups subject to LCI(Local corticosteroid Injection). The first group received four sessions of sham-ESWT weekly, which involved sound but no energy; the second group received ESWT at equal intervals and were assessed for pain score (VAS score) and symptoms (GSS) baseline, 1st month, 3rd month, and 6th month. Results: A considerable improvement is observed in both groups for pain at (P<0.05) and symptoms at (P<0.05) in the 3rd month. The second group revealed more significant symptom improvement at (P<0.05) in the 6th month. Conclusion: The ESWT + LCI combined therapy course is the first line of treatment in patients with mild to moderate symptoms and leads to control and reduction of symptoms and the need for surgery, thus a primary concern in CTS treatment with an orthopedist. Carpal tunnel syndrome extracorporeal shock wave therapy Injection Pain Figures Figure 1 Figure 2 Figure 3 Introduction Carpal tunnel syndrome (CTS), which appears by the pressure exerted on the median nerve in the carpal tunnel, is the most common peripheral neuropathy. Edema, tendonitis, and hormonal changes like hypothyroidism and menopause are involved and manual activity can play a role in increasing nerve compression.( 1 – 4 ) The syndrome occurs with symptoms like paresthesia, dysesthesia, anesthesia, weakness, and atrophy of the tenar muscle. These symptoms are usually concentrated in hand but can extend to the forearm, arm, and even shoulder ( 5 , 6 ). The risk factors for CTS are diabetes, menopause, hypothyroidism, obesity, osteoarthritis, pregnancy, and smoking ( 7 ). The diagnosis of CTS is mainly based on history, clinical findings, and examination through the Tinel's sign and Phalen test ( 8 ). The nerve conduction velocity (NCV) electrodiagnostic tests are usually run to confirm the diagnosis or differentiation from other diseases. Electrohydraulic shockwaves are the high-energy acoustic waves generated by the underwater explosion with high voltage electrodes. These shockwaves are of two types: 1) Radial shockwaves, the soft shocks, which are better for bigger treatment areas of superficial indications. Compressed air generates Radial pressure waves to accelerate blood circulation and the transmitter is applied to decelerate the speed, and 2) Focused shockwaves, the hard shocks penetrate deeper into the tissues than Radial shockwaves and target one specific area. The Focused shockwaves are beneficial to tissues close to the bone calcifications and non-unions. This shockwave is defined as a non-invasive procedure with a sequence of single-wave pulses at (100 MPa) pressure and (G10 Nsecs) velocity over a short period of (10 Kiloseconds) time generated on the body and concentrated in a specific part of the body ( 9 , 10 ). Many studies have revealed that this modality/shockwave is an effective and lasting way to reduce pain in soft tissue diseases like plantar fasciitis and Achilles tendinopathy. The inflammation in soft tissues is reduced through biochemical changes like nitric oxide (NO) ( 11 , 12 ). ESWT rapidly increases endothelial NO synthase (eNOS) activity in the treated cells. The first line of treatment approach in patients with mild to moderate CTS is patient education ( 13 ). Changes in habits like restricting wrist movement and reduced activity Heavy workloads should be considered as the first-line approach. Many conservative treatments exist, like wrist splints, steroid injections, and laser treatments, with limited effectiveness ( 14 , 15 ). The ESWT is a practical short-term non-invasive treatment for mild to moderate CTS and improves it. The objective is to evaluate the effect of ESWT as adjunctive therapy through LCI to reduce the pain and improve symptoms in mild to moderate patients. Methods And Materials This is a prospective clinical trial run from February to August 2020 on 47 patient within the 30 to 60 age range with paresthesia, dysesthesia, and Tenar muscle weakness who tested positive for Phalen and Tinel test. The tests’ outcomes are confirmed by neurophysiological tests (EMG-NCV) for mild to moderate CTS. Severity of CTS is as follows: normal (grade 0); very mild (grade 1), CTS demonstrable only with most sensitive tests; mild (grade 2), sensory nerve conduction velocity slow on finger/wrist measurement, normal terminal motor latency; moderate (grade 3), sensory potential preserved with motor slowing, distal motor latency to abductor pollicis brevis (APB) < 6.5 ms; severe (grade 4), sensory potentials absent but motor response preserved, distal motor latency to APB 6.5 ms; extremely severe (grade 6), sensory and motor potentials effectively unrecordable (surface motor potential from APB < 0.2 mV amplitude)( 16 ). The exclusion criteria consist of Diagnosis of sensory and/or motor neuropathy other than CTS, Previous wrist trauma, surgery for CTS, treatment with ultrasound, ESWT, or local corticosteroid injection, pregnancy, infection at the treatment site, Scar burn, and systemic diseases (Rheumatoid arthritis-lupus erythema-scleroderma). The study protocol is subject to the Institutional Review Board and the Ethics Committee of Shahid Beheshti University of Medical Sciences regulations, which are explained to the participants[IR.SBMU.RETECH.REC.1399.1150]. Applying night splints and other oral medications is prohibited during the course, and all patients sign an informed consent. The subjects are labeled and randomly assigned through a random assignment sequence generated by the software to group 1 (sham -ESWT) and group 2(ESWT). The triamcinolone acetone (1 ml) + lidocaine (1ml) is injected into all the areas between the palmaris longus tendon (PL) and the flexor carpi ulnaris tendon (FCU) in the wrist area once( 17 ). Local corticosteroid is injected 24 hours later to prevent skin sensitivity after the ESWT. Each patient is subjected to the ESWT (electromagnetic standard DUOLITH SD1, Storz Medical, Tägerwilen, Switzerland) device. In the second group, ESWT is performed in the first session at 2600 beats average (with focusing probe) and a very low, 0.03 mj / mm2 energy flux density. Depending on patient tolerance, this energy follows a gradual incremental pattern for the next three sessions. The pulse repetition frequency is 4 Hz. In the (sham-ESWT) group, the ESWT device waves less and generates sound. At this stage, the patient is seated with the arm on the table and the palm facing up, and the ESWT probe is held vertically to the zone between the tenar and hypothenar ridges. All participants underwent clinical follow-up before beginning the treatment, at the end of the 1st, 3rd, and 6th months for VAS scores, and filled out the GSS questionnaire. This questionnaire covers the pain, numbness, paresthesia, weakness/clumsiness, and nocturnal waking ( 18 ). The Scale of GSS begins from 0 (no symptoms) to 10 (very severe), with the 50 as the worst score. The pain severity is measured through the Visual Analog Scale (VAS) ( 19 ), where 0 and 10 indicate no pain and the most severe imaginable pain, respectively. All treatments are run by a team of one orthopedic and one physiotherapist. At the end of the 6th month, patients with exacerbation of paresthesia, finger tingling, and decreased strength symptoms are referred for surgery after being confirmed by the EMG-NCV. The statistical analyses are run in SPSS software (SPSS, Inc., Chicago, IL, USA, Version 16) with a significance level of 5% and a 95% confidence interval. Descriptive data are reported as the mean ± SD. A Chi-square test is run for qualitative variables, and a student’s t-test is run to compare pain and Global symptom scores between the subject groups. Repeated measurements of ANOVA is applied to compare the Visual Analog Scale score and Global Symptom score trends within and between the groups. Results Forty-seven patients are considered eligible for the study. After the inclusion and exclusion criteria, 40 patients, are selected and randomized into: (Sham-ESWT) (20patients, 20 wrists) and (ESWT) (20 patients, 20wrists) groups, Fig. (1 ). No adverse events are recorded during the study period, and all patients completed the six months of follow-up and underwent the final analysis, Fig. (1). The Sham-ESWT group consists of 15 females (75%), with 44.90 ± 10.42 age average, and the ESWT group, with 18 females (90%) with 45.15±9.22 age average. The groups were similar in age, gender, the proportion of dominant hand lesions, and duration of symptoms (P>0.05), Table 1 . Table1: Patients’ Demographic Variable Sham-ESWT Group ESWT Group P-Value Age(years) 44.90±10.42 45.15±9.22 0.423 Gender Male Female 5(25%) 1 5(75%) 2(10%) 18(90%) 0.885 Dominant hand lesion% 80% 70% 0.465 Duration of symptoms(weeks) 14.80±2.83 14.95±2.43 0.290 *P values of 0.05 or less are considered statically significant Table 2: The VAS and GSS of the subject groups compared Variable Sham-ESWT Group ESWL Group P-Value GSS score baseline 26.00±4.99 27.25±4.76 0.486 GSS score ( 1st month) 17.40±3.28 15.05±2.35 0.401 GSS score (3rd moth) 19.40±3.11 15.45±1.53 0.002 GSS score (6th month) 23.05±3.51 16.10±1.77 0.007 VAS score baseline 5.15±1.46 4.55±1.35 0.644 VAS score(1st month) 4.55±1.14 3.40±1.09 0.677 VAS score(3rd month) 4.20±1.50 1.70±0.80 0.006 VAS score(6th month) 5.25±1.83 2.4±0.99 0.008 Surgery required 15(75%) 8(40%) 0.025 *P values of 0.05 or less are considered statically significant The groups' pain VAS and GSS scores at the beginning, 1st, 3rd, and 6th months are compared. The pain VAS score is similar in both groups at the beginning, but after the 1st month, no statistically significant difference is observed between the groups at (p = 0.677). In the 3rd month, the pain score in the ESWT group is recorded as significantly lower than the sham-ESWT group at (p = 0.006). At the end of the follow-up, this score reveals a statistically significant difference between the groups at (P = 0.008). GSS score is not significantly different between groups at the 1st fallow up at (P = 0.486); after one month, the same holds at (P = 0.401).In the 3rd month, this score in the ESWT group is (15.45±1.53) and in the sham-ESWT group is (19.40±3.11) at (P = 0.002). At the end of the follow-up, this score reveals a statistically significant difference between the two groups at (P = 0.007), Table 2 . Pain score in both groups decreases significantly during the study period, more in the ESWT group at (P = 0.046) than in the sham-ESWT group, Fig. (2 ), though there exists a difference in their trend at (P = 0.005), Fig, (3). This decrease in both groups during the study period has statistical significance. At the end of the study period, 15 (75%) patients from the sham-ESWT group and 8 (40%) from the ESWT group are referred for carpal tunnel release, at (P = 0.025) statistically significant where fewer patients in the ESWT group require surgery. Discussion ESWT is a new non-invasive procedure applied extensively in recent years in treating soft tissue diseases like osteoarthritis (20) and peripheral neuropathy (15, 21, 22). The effect of LCI in treating mild to moderate carpal tunnel syndrome is evident. Researchers in (23) assessed 113 patients with carpal tunnel syndrome with less severe swelling on ultrasound, and the effect of single-dose corticosteroid injections revealed that after 67 follow-up periods of 12 months, about 67. 4% of patients required surgery. Their finding of this study correcpond with that of (23) . ESWT was first applied in the treatment of carpal tunnel syndrome (21), where it revealed that, according to the Levin-Boston questionnaire, statistically, the effect of one ESWT session was equal to that of one LCI session in CTS treatment at (P <0.05). The results of this study reveale that, in the short term, approximately five months after the end of treatment, patients with mild to moderate CTS, not surgery candidates, may benefit from the synergy of ESWT with LCI. Based on the findings here, patients in both groups had almost similar results in the early stages of follow-up concerning VAS and GSS criteria, while in the final stages, the second group showed better results. Although different performance criteria are applied in this study, the results correspond to that of the available studies. Researchers (24) reported that patients treated with ESWT have significantly lower VAS and the Boston Carpal Tunnel Questionnaire scores compared with the LCI group in 12 and 24 weeks of follow-up. Researchers in (25) revealed that patients significantly improved VAS scores in the 1st month, while the same increased statistically in the 3rd and 6th months. Researchers in (26) exhibited that in 14 patients with carpal tunnel syndrome treated with injectable corticosteroids, the clinical results are satisfactory, and the VAS score decreased significantly after one month at (P <0.05) but increased over 6th month, still less than the initial value, which corresponds with this study. Similar findings are evident in (24, 27). Due to the temporary anti-inflammatory effect of injectable steroids without changing the underlying cause of the disease, injection therapy lacks long-term efficacy.In many studies, nitric oxide produced by ESWT contributes to an increase in the angiogenesis growth factors’ level and inhibits inflammation through the suppressive production of pro-inflammatory cytokines (11, 12, 28, 29). According to (30), the second and subsequent sessions have a cumulative effect on a neuronal filament with longer analgesic effects. That the patients with mild to moderate carpal tunnel syndrome with pain and disability could merely benefit from 3 sessions of ESWT for at least 3 months, compared with ultrasound and cryopreservation is revealed by (15). That the effect of 3 sessions of combined ESWT with nocturnal splint or Isometric tendon training in patients with CTS for at least six months compared with a diet consisting of (Echinacea angomedolia, alpha lipoid acid, linoleic acid, and quercetin) significantly improves pain, the severity of symptoms and functional scores, and electrodiagnostic results are revealed in (29). They concluded that shock in association with ALA, GLA, and echinacea due to its antioxidant effect is an effective treatment to control symptoms and improve the development of CTS. Researchers in (31) first assessed the ESWT in a prospective, randomized, double-blind, placebo-controlled study and found that the benefit of ESWT in treating CTS becomes apparent after the 3rd follow-up. It can be deduced that this study is the first where corticosteroids are consumed as a supplementary with ESWT in patients with mild to moderate CTS; consequently, this study is subject to many limitations, like a small statistical population and short-term follow-up period. Another important restricting component here is the gender with a high count of females; if the same were males, the results might have varied. Accordingly, evaluation of the components that would indicate the possible mechanisms of ESWT and corticosteroids’ simultaneous action in future studies are of primary concern. CONCLUSIONS The findings of this study revealed that patients with mild to moderate carpal tunnel syndrome treated with a combination of shock and corticosteroids are rare candidates for surgery. Because ESWT is non-invasive, it is ideal to be applied in treating and controlling symptoms. Though the Surgical treatment is associated with rapid improvement of symptoms and good long-term results, the ESWT is recommended as a non-invasive first-line treatment, while surgery may be required in cases of recurrence. Declarations Ethical Approval Ethics approval is available IR.SBMU.RETECH.REC.1399.1150 Competing interests No conflict of interest Authors' contributions A: Morteza Gholipour B: Sona bonakdar C: Mona Gorji D: Reza Minaei "A.D. offer main title and B.C.prepared figures C,D wrote the main manuscript text . All authors reviewed the manuscript." Funding No funding Availability of data and materials is available References Shiri R. Hypothyroidism and carpal tunnel syndrome: a meta-analysis. Muscle Nerve. 2014 Dec;50(6):879-83. PubMed PMID: 25204641. Epub 2014/09/11. eng. Padua L, Di Pasquale A, Pazzaglia C, Liotta GA, Librante A, Mondelli M. Systematic review of pregnancy-related carpal tunnel syndrome. Muscle Nerve. 2010 Nov;42(5):697-702. PubMed PMID: 20976778. 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Cite Share Download PDF Status: Published Journal Publication published 01 Jul, 2023 Read the published version in Journal of Orthopaedic Surgery and Research → Version 1 posted Editorial decision: Major revision 23 Apr, 2023 Reviews received at journal 09 Apr, 2023 Reviewers agreed at journal 08 Apr, 2023 Reviewers agreed at journal 06 Apr, 2023 Reviewers agreed at journal 05 Apr, 2023 Reviews received at journal 04 Apr, 2023 Reviewers agreed at journal 27 Mar, 2023 Reviewers agreed at journal 25 Mar, 2023 Reviewers invited by journal 24 Mar, 2023 Editor assigned by journal 22 Mar, 2023 Submission checks completed at journal 22 Mar, 2023 First submitted to journal 03 Mar, 2023 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. 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Beheshti University of Medical Sciences","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"sona","middleName":"","lastName":"bonakdar","suffix":""},{"id":185641617,"identity":"3bdecf7d-ece0-4cba-8251-7e2b931aede7","order_by":2,"name":"mona gorji","email":"","orcid":"","institution":"Shahid Beheshti University of Medical Sciences","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"mona","middleName":"","lastName":"gorji","suffix":""},{"id":185641618,"identity":"36d0ac01-972b-4959-97a3-99d6ced4311e","order_by":3,"name":"reza minaei","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA9ElEQVRIiWNgGAWjYFAC5gbGBgMgLcHA/OBDBQODAWEtjBAtPBIMbIYzzhCthQGshUGat40ILbrtBxsfziiwybeXbj5gzDvvsLw5e/MBhh8V23BqMTuT2Gy4wSDNskfmWMLDudsOG+7sOZbA2HPmNm4tBxLbJB8YHDbgkcgxMHi77TDjhhs5BsyMbXi0nH/Y/hOmRYJ3zmF7wlpuJLYxboBqkeRtOJxIhJaHzZIzDNIMeG6kpRnOOJaevOHMsYSDeP1yPvngx54/NgbsM5IPP/hQY2274XjzwQc/KnBrQQfNYPIA0eqBoI4UxaNgFIyCUTBCAACCmGCWto5mQQAAAABJRU5ErkJggg==","orcid":"","institution":"Shahid Beheshti University of Medical Sciences","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"reza","middleName":"","lastName":"minaei","suffix":""}],"badges":[],"createdAt":"2023-03-03 17:29:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-2652602/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-2652602/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13018-023-03940-0","type":"published","date":"2023-07-01T21:26:01+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":34774110,"identity":"53de3f32-48c3-4cce-9089-f8e40081de73","added_by":"auto","created_at":"2023-03-24 14:15:48","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":28312,"visible":true,"origin":"","legend":"\u003cp\u003eThe study flowchart\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-2652602/v1/cc81a2cddd0ad32c74875838.png"},{"id":34774112,"identity":"76c41461-d7d1-499e-ac93-7e35024c386f","added_by":"auto","created_at":"2023-03-24 14:15:48","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":43845,"visible":true,"origin":"","legend":"\u003cp\u003eTrend of pain VAS score during the study period between two groups by repeated measurements of ANOVA\u003c/p\u003e\n\u003cp\u003e*The first group is Sham-ESWT, and the second group is ESWT\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-2652602/v1/34ed160eb5791f0c8f8d48ee.png"},{"id":34774111,"identity":"1554c528-1f5d-4d7f-9033-bb1b61d3aaaa","added_by":"auto","created_at":"2023-03-24 14:15:48","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":55523,"visible":true,"origin":"","legend":"\u003cp\u003eTrend of Global System score during the study period between two groups by repeated measurements of ANOVA\u003c/p\u003e\n\u003cp\u003e*The first group is Sham-ESWT, and the second group is ESWT\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-2652602/v1/f43712dfacc928c07255534f.png"},{"id":44732127,"identity":"9a3de262-2010-4dd5-bdab-c324d0fc4cef","added_by":"auto","created_at":"2023-10-16 21:53:17","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":362209,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-2652602/v1/67ba47ce-cb9c-49b6-94c6-6630655950ad.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Synergistic effect of local corticosteroid injection(LCI) with extracorporeal shock wave therapy(ESWT) in the treatment of patients with mild to moderate carpal tunnel syndrome(CTS): A Randomized Controlled Trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eCarpal tunnel syndrome (CTS), which appears by the pressure exerted on the median nerve in the carpal tunnel, is the most common peripheral neuropathy. Edema, tendonitis, and hormonal changes like hypothyroidism and menopause are involved and manual activity can play a role in increasing nerve compression.(\u003cspan additionalcitationids=\"CR2 CR3\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) The syndrome occurs with symptoms like paresthesia, dysesthesia, anesthesia, weakness, and atrophy of the tenar muscle. These symptoms are usually concentrated in hand but can extend to the forearm, arm, and even shoulder (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). The risk factors for CTS are diabetes, menopause, hypothyroidism, obesity, osteoarthritis, pregnancy, and smoking (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). The diagnosis of CTS is mainly based on history, clinical findings, and examination through the Tinel's sign and Phalen test (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e). The nerve conduction velocity (NCV) electrodiagnostic tests are usually run to confirm the diagnosis or differentiation from other diseases.\u003c/p\u003e \u003cp\u003eElectrohydraulic shockwaves are the high-energy acoustic waves generated by the underwater explosion with high voltage electrodes. These shockwaves are of two types: 1) Radial shockwaves, the soft shocks, which are better for bigger treatment areas of superficial indications. Compressed air generates Radial pressure waves to accelerate blood circulation and the transmitter is applied to decelerate the speed, and 2) Focused shockwaves, the hard shocks penetrate deeper into the tissues than Radial shockwaves and target one specific area. The Focused shockwaves are beneficial to tissues close to the bone calcifications and non-unions. This shockwave is defined as a non-invasive procedure with a sequence of single-wave pulses at (100 MPa) pressure and (G10 Nsecs) velocity over a short period of (10 Kiloseconds) time generated on the body and concentrated in a specific part of the body (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Many studies have revealed that this modality/shockwave is an effective and lasting way to reduce pain in soft tissue diseases like plantar fasciitis and Achilles tendinopathy. The inflammation in soft tissues is reduced through biochemical changes like nitric oxide (NO) (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). ESWT rapidly increases endothelial NO synthase (eNOS) activity in the treated cells. The first line of treatment approach in patients with mild to moderate CTS is patient education (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Changes in habits like restricting wrist movement and reduced activity Heavy workloads should be considered as the first-line approach. Many conservative treatments exist, like wrist splints, steroid injections, and laser treatments, with limited effectiveness (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). The ESWT is a practical short-term non-invasive treatment for mild to moderate CTS and improves it. The objective is to evaluate the effect of ESWT as adjunctive therapy through LCI to reduce the pain and improve symptoms in mild to moderate patients.\u003c/p\u003e"},{"header":"Methods And Materials","content":"\u003cp\u003eThis is a prospective clinical trial run from February to August 2020 on 47 patient within the 30 to 60 age range with paresthesia, dysesthesia, and Tenar muscle weakness who tested positive for Phalen and Tinel test. The tests\u0026rsquo; outcomes are confirmed by neurophysiological tests (EMG-NCV) for mild to moderate CTS. Severity of CTS is as follows: normal (grade 0); very mild (grade 1), CTS demonstrable only with most sensitive tests; mild (grade 2), sensory nerve conduction velocity slow on finger/wrist measurement, normal terminal motor latency; moderate (grade 3), sensory potential preserved with motor slowing, distal motor latency to abductor pollicis brevis (APB)\u0026thinsp;\u0026lt;\u0026thinsp;6.5 ms; severe (grade 4), sensory potentials absent but motor response preserved, distal motor latency to APB\u0026thinsp;\u0026lt;\u0026thinsp;6. 5 ms; very severe (grade 5), terminal latency to APB\u0026thinsp;\u0026gt;\u0026thinsp;6.5 ms; extremely severe (grade 6), sensory and motor potentials effectively unrecordable (surface motor potential from APB\u0026thinsp;\u0026lt;\u0026thinsp;0.2 mV amplitude)(\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). The exclusion criteria consist of Diagnosis of sensory and/or motor neuropathy other than CTS, Previous wrist trauma, surgery for CTS, treatment with ultrasound, ESWT, or local corticosteroid injection, pregnancy, infection at the treatment site, Scar burn, and systemic diseases (Rheumatoid arthritis-lupus erythema-scleroderma). The study protocol is subject to the Institutional Review Board and the Ethics Committee of Shahid Beheshti University of Medical Sciences regulations, which are explained to the participants[IR.SBMU.RETECH.REC.1399.1150]. Applying night splints and other oral medications is prohibited during the course, and all patients sign an informed consent. The subjects are labeled and randomly assigned through a random assignment sequence generated by the software to group 1 (sham -ESWT) and group 2(ESWT). The triamcinolone acetone (1 ml)\u0026thinsp;+\u0026thinsp;lidocaine (1ml) is injected into all the areas between the palmaris longus tendon (PL) and the flexor carpi ulnaris tendon (FCU) in the wrist area once(\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). Local corticosteroid is injected 24 hours later to prevent skin sensitivity after the ESWT.\u003c/p\u003e \u003cp\u003eEach patient is subjected to the ESWT (electromagnetic standard DUOLITH SD1, Storz Medical, T\u0026auml;gerwilen, Switzerland) device. In the second group, ESWT is performed in the first session at 2600 beats average (with focusing probe) and a very low, 0.03 mj / mm2 energy flux density. Depending on patient tolerance, this energy follows a gradual incremental pattern for the next three sessions. The pulse repetition frequency is 4 Hz. In the (sham-ESWT) group, the ESWT device waves less and generates sound. At this stage, the patient is seated with the arm on the table and the palm facing up, and the ESWT probe is held vertically to the zone between the tenar and hypothenar ridges. All participants underwent clinical follow-up before beginning the treatment, at the end of the 1st, 3rd, and 6th months for VAS scores, and filled out the GSS questionnaire. This questionnaire covers the pain, numbness, paresthesia, weakness/clumsiness, and nocturnal waking (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e). The Scale of GSS begins from 0 (no symptoms) to 10 (very severe), with the 50 as the worst score. The pain severity is measured through the Visual Analog Scale (VAS) (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e), where 0 and 10 indicate no pain and the most severe imaginable pain, respectively. All treatments are run by a team of one orthopedic and one physiotherapist. At the end of the 6th month, patients with exacerbation of paresthesia, finger tingling, and decreased strength symptoms are referred for surgery after being confirmed by the EMG-NCV. The statistical analyses are run in SPSS software (SPSS, Inc., Chicago, IL, USA, Version 16) with a significance level of 5% and a 95% confidence interval. Descriptive data are reported as the mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD. A Chi-square test is run for qualitative variables, and a student\u0026rsquo;s t-test is run to compare pain and Global symptom scores between the subject groups. Repeated measurements of ANOVA is applied to compare the Visual Analog Scale score and Global Symptom score trends within and between the groups.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eForty-seven patients are considered eligible for the study. After the inclusion and exclusion criteria, 40 patients, are selected and randomized into: (Sham-ESWT) (20patients, 20 wrists) and (ESWT) (20 patients, 20wrists) groups, \u003cstrong\u003eFig. (1\u003c/strong\u003e). No adverse events are recorded during the study period, and all patients completed the six months of follow-up and underwent the final analysis, Fig. (1). The Sham-ESWT group consists of 15 females (75%), with 44.90 \u0026plusmn; 10.42 age average, and the ESWT group, with 18 females (90%) with 45.15\u0026plusmn;9.22 age average. The groups were similar in age, gender, the proportion of dominant hand lesions, and duration of symptoms (P\u0026gt;0.05), \u003cstrong\u003eTable 1\u003c/strong\u003e.\u003c/p\u003e\n\u003cp\u003eTable1: Patients\u0026rsquo; Demographic\u003c/p\u003e\n\u003ctable border=\"1\" cellpadding=\"0\" cellspacing=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.46067415730337%\"\u003e\n \u003cp\u003eVariable\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"24.23756019261637%\"\u003e\n \u003cp\u003eSham-ESWT Group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"32.102728731942214%\"\u003e\n \u003cp\u003eESWT Group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.199036918138042%\"\u003e\n \u003cp\u003eP-Value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.46067415730337%\"\u003e\n \u003cp\u003eAge(years)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"24.23756019261637%\"\u003e\n \u003cp\u003e44.90\u0026plusmn;10.42\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"32.102728731942214%\"\u003e\n \u003cp\u003e45.15\u0026plusmn;9.22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.199036918138042%\"\u003e\n \u003cp\u003e0.423\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.46067415730337%\"\u003e\n \u003cp\u003eGender\u003c/p\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"24.23756019261637%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5(25%)\u003c/p\u003e\n \u003cp\u003e\u003cspan dir=\"RTL\"\u003e1\u003c/span\u003e5(75%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"32.102728731942214%\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2(10%)\u003c/p\u003e\n \u003cp\u003e18(90%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.199036918138042%\"\u003e\n \u003cp\u003e0.885\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.46067415730337%\"\u003e\n \u003cp\u003eDominant hand lesion%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"24.23756019261637%\"\u003e\n \u003cp\u003e80%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"32.102728731942214%\"\u003e\n \u003cp\u003e70%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.199036918138042%\"\u003e\n \u003cp\u003e0.465\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"31.46067415730337%\"\u003e\n \u003cp\u003eDuration of symptoms(weeks)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"24.23756019261637%\"\u003e\n \u003cp\u003e14.80\u0026plusmn;2.83\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"32.102728731942214%\"\u003e\n \u003cp\u003e14.95\u0026plusmn;2.43\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.199036918138042%\"\u003e\n \u003cp\u003e0.290\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e*P values of 0.05 or less are considered statically significant\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 2:\u0026nbsp;The VAS and GSS of the subject groups compared\u003c/p\u003e\n\u003ctable border=\"1\" cellpadding=\"0\" cellspacing=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"26.923076923076923%\"\u003e\n \u003cp\u003eVariable\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"26.121794871794872%\"\u003e\n \u003cp\u003eSham-ESWT Group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"34.77564102564103%\"\u003e\n \u003cp\u003eESWL Group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.179487179487179%\"\u003e\n \u003cp\u003eP-Value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"26.923076923076923%\"\u003e\n \u003cp\u003eGSS score baseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"26.121794871794872%\"\u003e\n \u003cp\u003e26.00\u0026plusmn;4.99\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"34.77564102564103%\"\u003e\n \u003cp\u003e27.25\u0026plusmn;4.76\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.179487179487179%\"\u003e\n \u003cp\u003e0.486\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"26.923076923076923%\"\u003e\n \u003cp\u003eGSS score ( 1st month)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"26.121794871794872%\"\u003e\n \u003cp\u003e17.40\u0026plusmn;3.28\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"34.77564102564103%\"\u003e\n \u003cp\u003e15.05\u0026plusmn;2.35\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.179487179487179%\"\u003e\n \u003cp\u003e0.401\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"26.923076923076923%\"\u003e\n \u003cp\u003eGSS score (3rd moth)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"26.121794871794872%\"\u003e\n \u003cp\u003e19.40\u0026plusmn;3.11\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"34.77564102564103%\"\u003e\n \u003cp\u003e15.45\u0026plusmn;1.53\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.179487179487179%\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.002\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"26.923076923076923%\"\u003e\n \u003cp\u003eGSS score (6th month)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"26.121794871794872%\"\u003e\n \u003cp\u003e23.05\u0026plusmn;3.51\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"34.77564102564103%\"\u003e\n \u003cp\u003e16.10\u0026plusmn;1.77\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.179487179487179%\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.007\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"26.923076923076923%\"\u003e\n \u003cp\u003eVAS score baseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"26.121794871794872%\"\u003e\n \u003cp\u003e5.15\u0026plusmn;1.46\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"34.77564102564103%\"\u003e\n \u003cp\u003e4.55\u0026plusmn;1.35\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.179487179487179%\"\u003e\n \u003cp\u003e0.644\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"26.923076923076923%\"\u003e\n \u003cp\u003eVAS score(1st month)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"26.121794871794872%\"\u003e\n \u003cp\u003e4.55\u0026plusmn;1.14\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"34.77564102564103%\"\u003e\n \u003cp\u003e3.40\u0026plusmn;1.09\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.179487179487179%\"\u003e\n \u003cp\u003e0.677\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"26.923076923076923%\"\u003e\n \u003cp\u003eVAS score(3rd month)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"26.121794871794872%\"\u003e\n \u003cp\u003e4.20\u0026plusmn;1.50\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"34.77564102564103%\"\u003e\n \u003cp\u003e1.70\u0026plusmn;0.80\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.179487179487179%\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.006\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"26.923076923076923%\"\u003e\n \u003cp\u003eVAS score(6th month)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"26.121794871794872%\"\u003e\n \u003cp\u003e5.25\u0026plusmn;1.83\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"34.77564102564103%\"\u003e\n \u003cp\u003e2.4\u0026plusmn;0.99\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.179487179487179%\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.008\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" width=\"26.923076923076923%\"\u003e\n \u003cp\u003eSurgery required\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"26.121794871794872%\"\u003e\n \u003cp\u003e15(75%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"34.77564102564103%\"\u003e\n \u003cp\u003e8(40%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" width=\"12.179487179487179%\"\u003e\n \u003cp\u003e\u003cstrong\u003e0.025\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e*P values of 0.05 or less are considered statically significant\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003eThe groups\u0026apos; pain VAS and GSS scores at the beginning, 1st, 3rd, and 6th months are compared. The pain VAS score is similar in both groups at the beginning, but after the 1st month, no statistically significant difference is observed between the groups at (p = 0.677). In the 3rd month, the pain score in the ESWT group is recorded as significantly lower than the sham-ESWT group at (p = 0.006). At the end of the follow-up, this score reveals a statistically significant difference between the groups at (P = 0.008). GSS score is not significantly different between groups at the 1st fallow up at (P = 0.486); after one month, the same holds at (P = 0.401).In the 3rd month, this score in the ESWT group is (15.45\u0026plusmn;1.53) and in the sham-ESWT group is (19.40\u0026plusmn;3.11) at (P = 0.002). At the end of the follow-up, this score reveals a statistically significant difference between the two groups at (P = 0.007), \u003cstrong\u003eTable 2\u003c/strong\u003e. Pain score in both groups decreases significantly during the study period, more in the ESWT group at (P = 0.046) than in the sham-ESWT group, \u003cstrong\u003eFig. (2\u003c/strong\u003e), though there exists a difference in their trend at (P = 0.005), Fig, (3). \u0026nbsp;This decrease in both groups during the study period has statistical significance. At the end of the study period, 15 (75%) patients from the sham-ESWT group and 8 (40%) from the ESWT group are referred for carpal tunnel release, at (P = 0.025) statistically significant where fewer patients in the ESWT group require surgery.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eESWT is a new non-invasive procedure applied extensively in recent years in treating soft tissue diseases like osteoarthritis\u0026nbsp;(20)\u0026nbsp;and peripheral neuropathy\u0026nbsp;(15, 21, 22). The effect of LCI in treating mild to moderate carpal tunnel syndrome is evident.\u0026nbsp;Researchers in (23)\u0026nbsp;assessed 113 patients with carpal tunnel syndrome with less severe swelling on ultrasound, and the effect of single-dose corticosteroid injections revealed that after 67 follow-up periods of 12 months, about 67. 4% of patients required surgery. Their finding of this study correcpond with that of\u0026nbsp;(23)\u003cstrong\u003e.\u003c/strong\u003e ESWT was first applied in the treatment of carpal tunnel syndrome\u0026nbsp;(21), where it revealed that, according to the Levin-Boston questionnaire, statistically, the effect of one ESWT session was equal to that of one LCI session in CTS treatment at (P \u0026lt;0.05). The results of\u0026nbsp;this\u0026nbsp;study reveale that, in the short term, approximately five months after the end of treatment, patients with mild to moderate CTS, not surgery candidates, may benefit from the synergy of ESWT with LCI.\u0026nbsp;Based on the findings here, patients in both groups had almost similar results in the early stages of follow-up concerning VAS and GSS criteria, while in the final stages, the second group showed better results. Although different performance criteria are applied in this study, the results correspond to that of the available studies. Researchers\u0026nbsp;(24)\u0026nbsp;reported that patients treated with ESWT have significantly lower VAS and the Boston Carpal Tunnel Questionnaire scores compared with the LCI group in 12 and 24 weeks of follow-up. Researchers in\u0026nbsp;(25)\u0026nbsp;revealed that patients significantly improved VAS scores in the 1st month, while the same increased statistically in the 3rd and 6th months.\u0026nbsp;Researchers in\u0026nbsp;(26)\u0026nbsp;exhibited that in 14 patients with carpal tunnel syndrome treated with injectable corticosteroids, the clinical results are satisfactory, and the VAS score decreased significantly after one month at (P \u0026lt;0.05) but increased over 6th month, still less than the initial value, which corresponds with this study. Similar findings are evident in\u0026nbsp;(24, 27). Due to the temporary anti-inflammatory effect of injectable steroids without changing the underlying cause of the disease, injection therapy lacks long-term efficacy.In many studies, nitric oxide produced by ESWT contributes to an increase in the angiogenesis growth factors\u0026rsquo; level and inhibits inflammation through the suppressive production of pro-inflammatory cytokines\u0026nbsp;(11, 12, 28, 29). According to\u0026nbsp;(30), the second and subsequent sessions have a cumulative effect on a neuronal filament with longer analgesic effects. That the patients with mild to moderate carpal tunnel syndrome with pain and disability could merely benefit from 3 sessions of ESWT for at least 3 months, compared with ultrasound and cryopreservation is revealed by (15). That the effect of 3 sessions of combined ESWT with nocturnal splint or Isometric tendon training in patients with CTS for at least six months compared with a diet consisting of (Echinacea angomedolia, alpha lipoid acid, linoleic acid, and quercetin) significantly improves pain, the severity of symptoms and functional scores, and electrodiagnostic results are revealed in (29). They concluded that shock in association with ALA, GLA, and echinacea due to its antioxidant effect is an effective treatment to control symptoms and improve the development of CTS. Researchers in\u0026nbsp;(31)\u0026nbsp;first assessed the ESWT in a prospective, randomized, double-blind, placebo-controlled study and found that the benefit of ESWT in treating CTS becomes apparent after the 3rd follow-up.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIt can be deduced that this study is the first where corticosteroids are consumed as a supplementary with ESWT in patients with mild to moderate CTS; consequently, this study is subject to many limitations, like a small statistical population and short-term follow-up period. Another important restricting component here is the gender with a high count of females; if the same were males, the results might have varied. Accordingly, evaluation of the components that would indicate the possible mechanisms of ESWT and corticosteroids\u0026rsquo; simultaneous action in future studies are of primary concern.\u0026nbsp;\u003c/p\u003e"},{"header":"CONCLUSIONS","content":"\u003cp\u003eThe findings of this study revealed that patients with mild to moderate carpal tunnel syndrome treated with a combination of shock and corticosteroids are rare candidates for surgery. Because ESWT is non-invasive, it is ideal to be applied in treating and controlling symptoms. Though the Surgical treatment is associated with rapid improvement of symptoms and good long-term results, the ESWT is recommended as a non-invasive first-line treatment, while surgery may be required in cases of recurrence.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthical Approval\u003c/strong\u003e \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEthics approval is available\u003c/p\u003e\n\u003cp\u003eIR.SBMU.RETECH.REC.1399.1150\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNo conflict of interest\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA: Morteza Gholipour\u003c/p\u003e\n\u003cp\u003eB: Sona bonakdar\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eC: Mona Gorji\u003c/p\u003e\n\u003cp\u003eD: Reza Minaei\u003c/p\u003e\n\u003cp\u003e\u0026quot;A.D. offer main title \u0026nbsp; \u0026nbsp;and B.C.prepared figures \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eC,D wrote the main manuscript text . All authors reviewed the manuscript.\u0026quot;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo funding\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eis available\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eShiri R. Hypothyroidism and carpal tunnel syndrome: a meta-analysis. Muscle Nerve. 2014 Dec;50(6):879-83. PubMed PMID: 25204641. Epub 2014/09/11. eng.\u003c/li\u003e\n\u003cli\u003ePadua L, Di Pasquale A, Pazzaglia C, Liotta GA, Librante A, Mondelli M. Systematic review of pregnancy-related carpal tunnel syndrome. Muscle Nerve. 2010 Nov;42(5):697-702. PubMed PMID: 20976778. Epub 2010/10/27. eng.\u003c/li\u003e\n\u003cli\u003ePourmemari MH, Shiri R. Diabetes as a risk factor for carpal tunnel syndrome: a systematic review and meta-analysis. 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Carpal tunnel syndrome incidence in a general population. Neurology. 2002 Jan 22;58(2):289-94. PubMed PMID: 11805259. Epub 2002/01/24. eng.\u003c/li\u003e\n\u003cli\u003ePadua L, Coraci D, Erra C, Pazzaglia C, Paolasso I, Loreti C, et al. Carpal tunnel syndrome: clinical features, diagnosis, and management. Lancet Neurol. 2016 Nov;15(12):1273-84. PubMed PMID: 27751557. Epub 2016/10/19. eng.\u003c/li\u003e\n\u003cli\u003eHammer DS, Adam F, Kreutz A, Kohn D, Seil R. Extracorporeal shock wave therapy (ESWT) in patients with chronic proximal plantar fasciitis: a 2-year follow-up. Foot Ankle Int. 2003 Nov;24(11):823-8. PubMed PMID: 14655885. Epub 2003/12/06. eng.\u003c/li\u003e\n\u003cli\u003eVulpiani MC, Trischitta D, Trovato P, Vetrano M, Ferretti A. Extracorporeal shockwave therapy (ESWT) in Achilles tendinopathy. A long-term follow-up observational study. J Sports Med Phys Fitness. 2009 Jun;49(2):171-6. PubMed PMID: 19528895. Epub 2009/06/17. eng.\u003c/li\u003e\n\u003cli\u003eMariotto S, de Prati AC, Cavalieri E, Amelio E, Marlinghaus E, Suzuki H. Extracorporeal shock wave therapy in inflammatory diseases: molecular mechanism that triggers anti-inflammatory action. Curr Med Chem. 2009;16(19):2366-72. PubMed PMID: 19601786. Epub 2009/07/16. eng.\u003c/li\u003e\n\u003cli\u003eCiampa AR, de Prati AC, Amelio E, Cavalieri E, Persichini T, Colasanti M, et al. Nitric oxide mediates anti-inflammatory action of extracorporeal shock waves. FEBS Lett. 2005 Dec 19;579(30):6839-45. PubMed PMID: 16325181. Epub 2005/12/06. eng.\u003c/li\u003e\n\u003cli\u003eHuisstede BM, Frid\u0026eacute;n J, Coert JH, Hoogvliet P. Carpal tunnel syndrome: hand surgeons, hand therapists, and physical medicine and rehabilitation physicians agree on a multidisciplinary treatment guideline\u0026mdash;results from the European HANDGUIDE Study. Arch Phys Med Rehabil. 2014 Dec;95(12):2253-63. PubMed PMID: 25127999. Epub 2014/08/17. eng.\u003c/li\u003e\n\u003cli\u003eO\u0026apos;Connor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. Cochrane Database Syst Rev. 2003;2003(1):Cd003219. PubMed PMID: 12535461. Pubmed Central PMCID: PMC6486195. Epub 2003/01/22. eng.\u003c/li\u003e\n\u003cli\u003ePaoloni M, Tavernese E, Cacchio A, D\u0026apos;Orazi V, Ioppolo F, Fini M, et al. Extracorporeal shock wave therapy and ultrasound therapy improve pain and function in patients with carpal tunnel syndrome. A randomized controlled trial. Eur J Phys Rehabil Med. 2015 Oct;51(5):521-8. PubMed PMID: 25697763. Epub 2015/02/24. eng.\u003c/li\u003e\n\u003cli\u003eBland JD. A neurophysiological grading scale for carpal tunnel syndrome. Muscle \u0026amp; Nerve: Official Journal of the American Association of Electrodiagnostic Medicine. 2000;23(8):1280-3.\u003c/li\u003e\n\u003cli\u003eRacasan O, Dubert T. The safest location for steroid injection in the treatment of carpal tunnel syndrome. J Hand Surg Br. 2005 Aug;30(4):412-4. PubMed PMID: 15950338. Epub 2005/06/14. eng.\u003c/li\u003e\n\u003cli\u003eHerskovitz S, Berger AR, Lipton RB. Low-dose, short-term oral prednisone in the treatment of carpal tunnel syndrome. Neurology. 1995 Oct;45(10):1923-5. PubMed PMID: 7477994. Epub 1995/10/01. eng.\u003c/li\u003e\n\u003cli\u003eGould D, Kelly D, Goldstone L, Gammon J. Examining the validity of pressure ulcer risk assessment scales: developing and using illustrated patient simulations to collect the data. J Clin Nurs. 2001 Sep;10(5):697-706. PubMed PMID: 11822520. Epub 2002/02/02. eng.\u003c/li\u003e\n\u003cli\u003eLiu SC, Qiao XF, Tang QX, Li XG, Yang JH, Wang TQ, et al. Therapeutic efficacy of extracorporeal shock wave combined with hyaluronic acid on knee osteoarthritis. Medicine (Baltimore). 2019 Feb;98(8):e14589. PubMed PMID: 30813181. Pubmed Central PMCID: PMC6408132. Epub 2019/03/01. eng.\u003c/li\u003e\n\u003cli\u003eSeok H, Kim SH. The effectiveness of extracorporeal shock wave therapy vs. local steroid injection for management of carpal tunnel syndrome: a randomized controlled trial. Am J Phys Med Rehabil. 2013 Apr;92(4):327-34. PubMed PMID: 23044704. Epub 2012/10/10. eng.\u003c/li\u003e\n\u003cli\u003eHui AC, Wong S, Leung CH, Tong P, Mok V, Poon D, et al. A randomized controlled trial of surgery vs steroid injection for carpal tunnel syndrome. Neurology. 2005 Jun 28;64(12):2074-8. PubMed PMID: 15985575. Epub 2005/06/30. eng.\u003c/li\u003e\n\u003cli\u003eMeys V, Thissen S, Rozeman S, Beekman R. Prognostic factors in carpal tunnel syndrome treated with a corticosteroid injection. Muscle \u0026amp; nerve. 2011;44(5):763-8.\u003c/li\u003e\n\u003cli\u003eAtthakomol P, Manosroi W, Phanphaisarn A, Phrompaet S, Iammatavee S, Tongprasert S. Comparison of single-dose radial extracorporeal shock wave and local corticosteroid injection for treatment of carpal tunnel syndrome including mid-term efficacy: a prospective randomized controlled trial. BMC Musculoskelet Disord. 2018 Jan 25;19(1):32. PubMed PMID: 29370788. Pubmed Central PMCID: PMC5784684. Epub 2018/01/27. eng.\u003c/li\u003e\n\u003cli\u003eCelik G, Ilik MK. Effects of Two Different Treatment Techniques on the Recovery Parameters of Moderate Carpal Tunnel Syndrome: A Six-Month Follow-up Study. J Clin Neurophysiol. 2016 Apr;33(2):166-70. PubMed PMID: 26657237. Epub 2015/12/15. eng.\u003c/li\u003e\n\u003cli\u003eMilo R, Kalichman L, Volchek L, Reitblat T. Local corticosteroid treatment for carpal tunnel syndrome: a 6-month clinical and electrophysiological follow-up study. J Back Musculoskelet Rehabil. 2009;22(2):59-64. PubMed PMID: 20023332. Epub 2009/12/22. eng.\u003c/li\u003e\n\u003cli\u003eChesterton LS, Blagojevic-Bucknall M, Burton C, Dziedzic KS, Davenport G, Jowett SM, et al. The clinical and cost-effectiveness of corticosteroid injection versus night splints for carpal tunnel syndrome (INSTINCTS trial): an open-label, parallel group, randomised controlled trial. Lancet. 2018 Oct 20;392(10156):1423-33. PubMed PMID: 30343858. Pubmed Central PMCID: PMC6196880. Epub 2018/10/23. eng.\u003c/li\u003e\n\u003cli\u003eMariotto S, Cavalieri E, Amelio E, Ciampa AR, de Prati AC, Marlinghaus E, et al. Extracorporeal shock waves: from lithotripsy to anti-inflammatory action by NO production. Nitric Oxide. 2005 Mar;12(2):89-96. PubMed PMID: 15740982. Epub 2005/03/03. eng.\u003c/li\u003e\n\u003cli\u003eGotte G, Amelio E, Russo S, Marlinghaus E, Musci G, Suzuki H. Short-time non-enzymatic nitric oxide synthesis from L-arginine and hydrogen peroxide induced by shock waves treatment. FEBS Lett. 2002 Jun 5;520(1-3):153-5. PubMed PMID: 12044888. Epub 2002/06/05. eng.\u003c/li\u003e\n\u003cli\u003eTakahashi N, Ohtori S, Saisu T, Moriya H, Wada Y. Second application of low-energy shock waves has a cumulative effect on free nerve endings. Clin Orthop Relat Res. 2006 Feb;443:315-9. PubMed PMID: 16462457. Epub 2006/02/08. eng.\u003c/li\u003e\n\u003cli\u003eWu YT, Ke MJ, Chou YC, Chang CY, Lin CY, Li TY, et al. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial. J Orthop Res. 2016 Jun;34(6):977-84. PubMed PMID: 26610183. Epub 2015/11/27. eng.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"journal-of-orthopaedic-surgery-and-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"josr","sideBox":"Learn more about [Journal of Orthopaedic Surgery and Research](http://josr-online.biomedcentral.com)","snPcode":"13018","submissionUrl":"https://submission.nature.com/new-submission/13018/3","title":"Journal of Orthopaedic Surgery and Research","twitterHandle":"@MSKmedBMC","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Carpal tunnel syndrome, extracorporeal shock wave therapy, Injection, Pain ","lastPublishedDoi":"10.21203/rs.3.rs-2652602/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-2652602/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e\u003c/em\u003e Applying extracorporeal shock wave therapy (ESWT) injection in carpal tunnel syndrome (CTS) management is gaining momentum. The objective is to actualize the topic of this study.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eMethods: \u003c/strong\u003e\u003c/em\u003eIn this prospective randomized controlled trial, forty patients with mild to moderate CTS are divided into two sham-ESWT and ESWL groups subject to LCI(Local corticosteroid Injection). The first group received four sessions of sham-ESWT weekly, which involved sound but no energy; the second group received ESWT at equal intervals and were assessed for pain score (VAS score) and symptoms (GSS) \u0026nbsp;baseline, 1st month, 3rd month, and 6th month.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eResults:\u003c/strong\u003e\u003c/em\u003e\u003cstrong\u003e \u003c/strong\u003eA considerable improvement is observed in both groups for pain at (P\u0026lt;0.05) and symptoms at (P\u0026lt;0.05) in the 3rd month. The second group revealed more significant symptom improvement at (P\u0026lt;0.05) in the 6th month.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e\u003c/em\u003e\u003cstrong\u003e \u003c/strong\u003eThe ESWT + LCI combined therapy course is the first line of treatment in patients with mild to moderate symptoms and leads to control and reduction of symptoms and the need for surgery, thus a primary concern in CTS treatment with an orthopedist.\u003c/p\u003e","manuscriptTitle":"Synergistic effect of local corticosteroid injection(LCI) with extracorporeal shock wave therapy(ESWT) in the treatment of patients with mild to moderate carpal tunnel syndrome(CTS): A Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2023-03-24 14:15:43","doi":"10.21203/rs.3.rs-2652602/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2023-04-23T11:55:26+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2023-04-09T05:14:56+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"6d901422-cb41-4e79-8f46-0bb031c6de88","date":"2023-04-08T18:11:22+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"768a3378-5e56-4689-a52c-c6ec95cfb32e","date":"2023-04-06T08:43:36+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"65966ae8-aabf-4c7f-b25d-b9aa9afcb1a9","date":"2023-04-06T00:08:13+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2023-04-04T19:20:32+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"059a5cf0-f8a6-4e3f-9596-c055f2a9dbcb","date":"2023-03-28T02:37:55+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"85b05ec4-02e6-4bf3-b3cc-5529c73dcee1","date":"2023-03-25T16:33:19+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2023-03-24T08:08:32+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2023-03-23T01:55:11+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2023-03-22T13:59:16+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of Orthopaedic Surgery and Research","date":"2023-03-03T17:24:12+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"journal-of-orthopaedic-surgery-and-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"josr","sideBox":"Learn more about [Journal of Orthopaedic Surgery and Research](http://josr-online.biomedcentral.com)","snPcode":"13018","submissionUrl":"https://submission.nature.com/new-submission/13018/3","title":"Journal of Orthopaedic Surgery and Research","twitterHandle":"@MSKmedBMC","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"7fc87066-97ad-4d21-ba96-2c2e3b649b02","owner":[],"postedDate":"March 24th, 2023","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2023-10-16T21:36:49+00:00","versionOfRecord":{"articleIdentity":"rs-2652602","link":"https://doi.org/10.1186/s13018-023-03940-0","journal":{"identity":"journal-of-orthopaedic-surgery-and-research","isVorOnly":false,"title":"Journal of Orthopaedic Surgery and Research"},"publishedOn":"2023-07-01 21:26:01","publishedOnDateReadable":"July 1st, 2023"},"versionCreatedAt":"2023-03-24 14:15:43","video":"","vorDoi":"10.1186/s13018-023-03940-0","vorDoiUrl":"https://doi.org/10.1186/s13018-023-03940-0","workflowStages":[]},"version":"v1","identity":"rs-2652602","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-2652602","identity":"rs-2652602","version":["v1"]},"buildId":"WrCJVZZCHTDjtuVLN7oU0","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}