Effect of TENS and stabilization exercises on pelvic pain in pelvic cancer survivors following multimodal treatment

Pelvic cancers are commonly a life-threatening condition that can be fatal, especially when left undetected and untreated. It refers to variety of cancers involving all the structures and organs in the pelvis.[] For males, it includes prostrate and testicular cancers, whereas ovarian, cervical, uterine and endometrial, vaginal, and vulvar cancers are among the females. Colorectal and bladder cancers are common in both the sexes in terms of occurrence.[] The burden of gynecological cancer in developing countries appear huge, which accounts for 25% of all the new cancers diagnosed among the women aged up to 65 years compared to 16% in developed places. India's National Cancer Control Program emphasizes the importance of its early detection and treatment.[] Treatment decisions are based on clinician recommendation and patients' values and preferences.[] Multimodal treatments such as surgery, radiation, chemotherapy and their combination, immunotherapy, and hormone replacement therapy are followed by common physical problems such as urinary symptoms, sexual dysfunction, lymphedema, pelvis or bladder pain, urinary or fecal incontinence, pelvic floor muscle (PFM) weakness, and burning sensations in the urinary tract.[] Pelvic cancer survivors have significantly more psychological issues with body image, menopause, sexual needs, and low level of optimism than the general population, especially among the younger age group. Radiation and chemotherapy to the pelvis causes irritation and damage to the bowel, bladder, and urinary tract functions, which begins after treatment and takes several weeks to subside. Postsurgical treatment is associated with long-term adverse effects on pelvic floor function. Physical activity and exercises are probably the most important therapeutic modality for the management of physical disabilities and complications.[] Pelvic floor physical therapy, including dilators, PFM strengthening and relaxation exercises, intravaginal massage techniques, and biofeedback, can help correct muscle imbalance, improve blood flow, and increase flexibility of paravaginal tissue. The importance of synergetic activation pattern might be a smart option to help coactivation of the abdominal muscles and PFMs in the rehabilitation program of patients with pelvic pain.[] Neuromodulation is a nondestructive, neuromodulatory technique that delivers electrical stimulation to the spinal cord or peripheral nerves for the treatment of pain.[] Although pelvic pain and muscle weakness is common, it sometimes goes undiagnosed and unknown resulting in patient frustration, delayed treatment, symptom alleviation, and increased cost expenses for future investigations. Very few studies have been carried out to establish new treatment regimens to aid in the pelvic floor rehabilitation process. The objective of the present study was to evaluate the effect of transcutaneous electrical nerve stimulation (TENS) and stabilization exercises on pelvic pain in pelvic cancer survivors following multimodal treatment. We hypothesized that there would be change in the effect of TENS and stabilization exercises on pelvic pain in pelvic cancer survivors following multimodal treatment.

Study design and setting This clinical trial was conducted in a tertiary care hospital aimed at studying the effect of TENS and stabilization exercises on pelvic pain in pelvic cancer survivors following multimodal treatment. All male and female patients within the age group of 18–75 years, diagnosed with any type of pelvic cancer including Stage 1, 2, or 3 according to tumor–node–metastasis staging, who have undergone either chemotherapy, radiation therapy, its combination or surgery, with history of pelvic pain related to pelvic cancer, and willing to participate in the study were included in the study. Patients were excluded if they had any sensory deficits, pacemaker in situ, or any comorbid medical or psychiatric illness that would impede completion or interfere with the treatment protocol. Description of the participants Thirty-one adults' subjects including 6 males and 25 females with pelvic cancer participants who underwent multimodal treatment forms for the same. Procedure Ethical clearance was obtained from the Research and Ethics Committee, Belagavi. The purpose of the study was explained in the subject's vernacular language and written informed consent was obtained from all the participants. All subjects were screened based on the inclusion and exclusion criteria prior to their enrolment into the study. Brief demographic data of all the subjects were noted. All subjects were evaluated for pelvic pain using outcome measures such as visual analog scale (VAS), genitourinary pain index (GUPI) to assess pelvic pain, pressure biofeedback unit (PBU) to measure transverse abdominal (TrA) muscle strength, and functional assessment of cancer therapy–general (FACT-G) questionnaire to evaluate quality of life (QOL) on the first and the last day of the intervention. Intervention protocol The subjects were given high-frequency, low-intensity TENS of low amplitude for a duration 100–200 μs and frequency of 10–200 pps for 15 min of continuous mode type. Placement of electrodes Two carbon electrodes were placed on the lower lumbar and two other electrodes were placed on the skin overlying the perianal suprapubic region in order to target the painful pelvic area. Position of the patient Patient is placed supine or sitting position according to their convenience. During the administration of TENS, if the patient felt any discomfort, it was immediately stopped.[] Exercise protocol After treatment with conventional TENS, the subjects were instructed to perform core stabilizing exercises focusing on TrA muscle that concentrated equally on the tone of the pelvic floor musculature.[] The following were the exercises given to all the subjects which were performed for 2 sets of 10 repetitions each with 2 min rest in between. Static abdominal exercises (tummy-tuck) Position The subject was in a crook lying position and arms along the sides. Activity He/she was asked to draw in the abdominals by pressing lumbar region down on plinth and place his/her fingers on abdominal wall at the waist line. He/she was asked to activate lower abdominal wall by gently drawing inward the area beneath. Duration In this position, the subject was asked to maintain this abdominal activation for up to 10 s along with normal breathing throughout the treatment. Pelvic bridging Position The subject was in a supine lying position with arms along the sides, knees flexed, and feet flat on the bed. Activity He/she was asked to contract the abdominal muscles to stabilize the back, hips, and pelvis. Then, he/she was instructed to lift his/her hips up off the floor into a bridge, so that the body forms one straight line from the shoulders to the knees. Duration In this position, the subject was asked to maintain this position for up to 10 s along with normal breathing throughout the treatment. Supported wall squats Position The subject was instructed to stand with his/her back against a wall/door with the feet and hip width apart. The feet had to be about 2 foot away from the wall, to ensure that the knees would not move forward of the toe. Back was maintained flat and not arched against the wall with tight contraction of the core muscles. Activity He/she was instructed to slowly slide down the wall at a sitting position as far as he/she feels comfortable to hold ensuring that the knees do not fall into the midline, or the body does not to sway to one side. Duration The subject was instructed to hold the position for as long as he/she can aim for 1 min maximum. The subject was asked to return to an upright posture, by pushing both feet equally and maintaining the back straight against the wall. Seated abdominal exercise Position The subject was asked to sit on a chair with both the hands supported at the sides or on the armrest of the chair. Activity The subject was instructed to keep his/her knees together, and the abdominal core tight and lift the feet off the floor, hold bringing knees toward the chest. Duration The subject had to hold this position for 10 s and then relax. The entire treatment lasted for approximately 30–40 min. The treatment was delivered during the hospital stay of all the subjects. All the questionnaires and the strength of the abdominal muscles were assessed using pressure biofeedback before the beginning of intervention and on the last day of hospitalization. Outcome measures Visual analogue scale The VAS of pain consists of a line, usually 10 cm long, with each end of the line labeled with descriptors representing the extremes of pain intensity (e.g., no pain, extreme pain). Test–retest reliability has been reported to be high for the VAS (intraclass correlation coefficient [ICC] = 0.71–0.99), while concurrent validity has been found to be moderate for the VAS (0.71–0.78). VAS is considered a strong, clinically useful, reliable, and valid measure of pain intensity.[] Genitourinary pain index The GUPI developed from the National Institutes of Health Chronic Prostatitis Symptom Index is used to assess the symptoms in both men and women with genitourinary complaints. It demonstrates good discriminant validity, reliability, and responsiveness to change. (sensitivity 100% and specificity 76%).[] Functional assessment of cancer therapy general questionnaire The FACT-G assesses the impact of cancer treatment in four domains of physical well-being, social/family well-being, emotional well-being, and functional well-being. Test–retest reliability is 0.92 for the total scale and subscales range from 0.82 to 0.88.[] Pressure biofeedback unit PBU is used for clinical evaluation to indirectly measure TrA muscle activity. The intrarater reliability ICCs of TrA muscle thickness were >0.995, indicating excellent reliability. Interrater reliability ICCs ranged from 0.963 to 0.987. The PBU exhibits high reliability.[] Statistical analysis Statistical analysis for the present study was done using Statistical Package for the Social Sciences (IBM Corp. Released 2015. IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp.) to verify the results obtained. Various statistical measures such as mean, mean difference, standard error, and standard deviation were used. Nominal data such as patient's demographic data, i.e., age, body mass index (kg/m2), height (meters), and weight (kgs) distribution, were analyzed. Normality of all the parameters was determined by Kolmogorov–Smirnov test. Since the data set did not follow a normal distribution, the researcher could not apply the dependent paired t-test. Hence, Wilcoxon paired test was used for within-group analysis of the VAS, GUPI, pressure biofeedback for muscle strength, and FACT-G questionnaire. With study power of 95%, probability values of less P ≤ 0.05 were considered statistically significant.

The present study included 31 patients who received an intervention comprising of pelvic stabilization exercises and TENS. The pre- and post-test intervention results were based on outcome measures which included pain assessed by the VAS and TrA muscle strength using PBU, and urinary symptoms were evaluated by GUPI and QOL by FACT-G questionnaire. The comparison of pretest and posttest VAS scores was found to be statistically highly significant in all the patients in the study with P = 0.001. GUPI of showed statistical improvement with P = 0.001 at the end of the study. Abdominal strength showed improvement with a statistical significance of P = 0.001. QOL demonstrated improvements in all components (P = 0.001) except for the social component.

The present study was undertaken to evaluate the combined effect of TENS and pelvic stabilization exercises or pelvic pain in pelvic cancer survivors undergoing multimodal treatments which prove the alternate hypothesis as the intervention protocol was effective in reducing pelvic pain in all the patients in the study. Thirty-one patients were enrolled in the study who received an intervention comprising pelvic stabilization exercises and TENS during the hospitalization phase. It demonstrates an alleviation of pain assessed by the VAS and GUPI, an increase in strength of TrA musculature which was checked using PBU, and improvement in QOL by the FACT-G questionnaire overall in 31 patients. Reduction in the levels of pain according to VAS was the highlight of this study. Prostate cancer patients with pelvic pain who received PFM program training, manual therapy for trigger points, therapeutic exercise to improve range, flexibility and strength, biofeedback to facilitate strength, and relaxation of PFM and neuromodulation for pain relief have shown improvements in terms of decrease in pain, GUPI scores, and improvement in the TrA muscle strength.[] The exercises regimen administered in the present study which aimed to maintain spine stability, abdominal diaphragm superiorly, PFM inferiorly, TrA anteriorly, and deep lumbar extensors muscles posteriorly justifying the improvement in the abdominal muscle strength. It plays an important role not only in trunk and lumbopelvic stability but also in maintenance of continence. Similar exercises focusing on PFM on urinary continence in 60 women between 45 and 60 years old have shown to have improved urinary incontinence and low back pain. The synergetic activation pattern may help in improving and rehabilitating patients with pelvic floor dysfunction.[] PFM biofeedback training in one hundred men who underwent radical prostatectomy receiving graded pelvic muscle exercise have shown to be beneficial in reducing the incontinence status and muscle strength. This finding correlates with the results of the present study of positive changes in the TrA muscle strength after the pelvic floor stabilization exercises.[] QOL of all the patients in the present study have demonstrated improvements according to the FACT-G questionnaire with significant improvements in all components of the questionnaire, namely physical, emotional, and functional except for social being component. Improvement in QOL may also have been attributed to the integrated effect of physical exercise and TENS.[] Exercise has shown to dampen the feelings of depression, tension, anxiety, anger, hostility, helplessness, and pessimism, thereby enhancing the social dimension of QOL.[] Female predominance was observed in the current study with 25 female and 6 male patients, which shows that it tends to arise more in females due to the changes in the female reproductive organs.[] The presence of stomal/urostomy bags has an impact on the health-related QOL (HRQOL) that causes discomfort and risk of developing hernia.[] This may be one of the resulting reasons for an overall improvement in the HRQOL in all the subjects in the present study since 26 subjects did not have presence of a stoma bag. To conclude, the study findings demonstrate an alleviation of pain assessed by the VAS and GUPI, an increase in strength of TrA musculature which was checked using PUB and improvement in QOL by the FACT-G questionnaire. Thus, the combination of TENS and pelvic stabilization exercises can be used as a strategic tool to reduce pain in pelvic cancer survivors receiving multimodal treatments in the clinical settings. Similar studies may be carried out in larger populations in different clinical settings in the Indian scenario as this therapy was associated with minimal side effects than those of surgical and medical procedures. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest. Acknowledgment We are grateful to the medical director, tertiary care hospital, for granting permission to conduct the study, the statistician, and all participants for participating in the study without whom the study would not have been possible.

- 1. Karnath BM, Karnath BM, Breitkopf DM. Acute and chronic pelvic pain in women Hospital Physician. 2007;43:41–8 - 2. Akbari ME, Hosseini SJ, Rezaee A, Hosseini MM, Rezaee I, Sheikhvatan M. Incidence of genitourinary cancers in the Islamic Republic of Iran: A survey in 2005 Asian Pac J Cancer Prev. 2008;9:549–52 - 3. Chassagne D, Sismondi P, Horiot JC, Sinistrero G, Bey P, Zola P, et al A glossary for reporting complications of treatment in gynecological cancers Radiother Oncol. 1993;26:195–202 - 4. Kwon JW, Huh SJ, Yoon YC, Choi SH, Jung JY, Oh D, et al Pelvic bone complications after radiation therapy of uterine cervical cancer: Evaluation with MRI AJR Am J Roentgenol. 2008;191:987–94 - 5. Passavanti MB, Pota V, Sansone P, Aurilio C, De Nardis L, Pace MC. Chronic pelvic pain: Assessment, evaluation, and objectivation Pain Res Treat. 2017;2017:1–15 - 6. Ghaderi F, Mohammadi K, Sasan RA, Kheslat SN, Oskouei AE. Effects of stabilization exercises focusing on pelvic floor muscles on low back pain and urinary incontinence in women Urology. 2016;93:50–4 - 7. Schwartz AL. Physical activity after a cancer diagnosis: Psychosocial outcomes Cancer Invest. 2004;22:82–92 - 8. Marcelissen T, Jacobs R, Van Kerrebroeck P, de Wachter S. Sacral neuromodulation as a treatment for chronic pelvic pain J Urol. 2011;186:387–93 - 9. Robertson V, Ward A, Low J, Reed A Electrotherapy explained principles and practice. 20154th New Delhi:174–78 - 10. Clemens JQ, Calhoun EA, Litwin MS, McNaughton-Collins M, Kusek JW, Crowley EM, et al Validation of a modified National Institutes of Health chronic prostatitis symptom index to assess genitourinary pain in both men and women Urology. 2009;74:983–7 quiz 987.e1-3. - 11. Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale Pain. 1983;16:87–101 - 12. Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, et al Reliability and validity of the functional assessment of cancer therapy-breast quality-of-life instrument J Clin Oncol. 1997;15:974–86 - 13. de Paula Lima PO, de Oliveira RR, Costa LO, Laurentino GE. Measurement properties of the pressure biofeedback unit in the evaluation of transversus abdominis muscle activity: A systematic review Physiotherapy. 2011;97:100–6 - 14. Rosenbaum TY, Owens A. Continuing medical education: The role of pelvic floor physical therapy in the treatment of pelvic and genital pain-related sexual dysfunction (CME) J Sexual Med. 2008;5:513–23 - 15. Loh J, Gulati A. The use of transcutaneous electrical nerve stimulation (TENS) in a major cancer center for the treatment of severe cancer-related pain and associated disability Pain Med. 2015;16:1204–10 - 16. Lindgren A, Dunberger G, Enblom A. Experiences of incontinence and pelvic floor muscle training after gynaecologic cancer treatment Support Care Cancer. 2017;25:157–66 - 17. Zhang AY, Strauss GJ, Siminoff LA. Effects of combined pelvic floor muscle exercise and a support group on urinary incontinence and quality of life of postprostatectomy patients Oncol Nurs Forum. 2007;1:47–53 - 18. Fialka-Moser V, Crevenna R, Korpan M, Quittan M. Cancer rehabilitation: Particularly with aspects on physical impairments J Rehabil Med. 2003;35:153–62 - 19. Donovan K, Sanson-Fisher RW, Redman S. Measuring quality of life in cancer patients J Clin Oncol. 1989;7:959–68 - 20. Johnson JB, Kelly AW. A multifaceted rehabilitation program for women with cancer Oncol Nurs Forum. 1990;17:691–5 - 21. Hubbard G, Taylor C, Beeken B, Campbell A, Gracey J, Grimmett C, et al Research priorities about stoma-related quality of life from the perspective of people with a stoma: A pilot survey Health Expectations. 2017;20:1421–7