{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T19:07:06Z","timestamp":1782846426108,"version":"3.54.5"},"reference-count":29,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Transcutaneous electrical nerve stimulation (TENS) works on the principle of the gate control theory of pain and is used as a nonpharmacological pain management intervention. Music therapy or listening to self-selected music has also been shown to reduce pain intensity, anxiety, and depression. There has been no published literature that has explored whether these modalities can work synergistically.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This study aims to test the feasibility of a clinical trial comparing TENS alone to TENS combined with self-selected music in participants with persistent low-back pain lasting more than 3 months.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n This will be a prospective, randomized controlled pilot study to compare TENS alone vs TENS combined with participant self-selected music. We hope to enroll 20 participants. The participants will be their own controls, and the order in which the intervention is delivered will be determined by randomization.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n The study is open for recruitment from August 2025. The results are expected in 18 months from the start of recruitment. The primary outcome will be the feasibility of the intervention, monitored by adherence rate, dropout rate, and the percentage of the eligible population that consented. Secondary outcomes collected will include pain intensity; mood using the 21-item Depression, Anxiety, and Stress Scale; medication consumption; participant satisfaction; and adverse reactions.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n If the pilot trial is feasible and indicates a positive synergistic trend with TENS and music, the trial will help to inform the feasibility for a larger trial with more varied pain diagnoses, including acute and chronic pain.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/82382","type":"journal-article","created":{"date-parts":[[2026,2,24]],"date-time":"2026-02-24T22:11:04Z","timestamp":1771971064000},"page":"e82382-e82382","source":"Crossref","is-referenced-by-count":0,"title":["Transcutaneous Electrical Nerve Stimulation vs Transcutaneous Electrical Nerve Stimulation With Music in Persistent Low-Back Pain: Protocol for a Pilot Feasibility Trial"],"prefix":"10.2196","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2850-6666","authenticated-orcid":false,"given":"Seema","family":"Radhakrishnan","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-3743-9968","authenticated-orcid":false,"given":"Michael","family":"Glynn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-5055-1567","authenticated-orcid":false,"given":"Anne-Marie","family":"Robertson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-0414-469X","authenticated-orcid":false,"given":"Anna","family":"Fedyczkowski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6303-860X","authenticated-orcid":false,"given":"Lieu","family":"Trinh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0338-1203","authenticated-orcid":false,"given":"Sabrina","family":"Naz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,2,24]]},"reference":[{"issue":"6","key":"R1","doi-asserted-by":"publisher","first-page":"e316","DOI":"10.1016\/S2665-9913(23)00098-X","article-title":"Global, regional, and national burden of low back pain, 1990-2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021","volume":"5","author":"Ferreira","journal-title":"Lancet Rheumatol"},{"issue":"11","key":"R2","doi-asserted-by":"publisher","first-page":"1904","DOI":"10.1111\/add.16616","article-title":"Prevalence of problematic pharmaceutical opioid use in patients with chronic non-cancer pain: a systematic review and meta-analysis","volume":"119","author":"Thomas","journal-title":"Addiction"},{"issue":"1","key":"R3","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-023-03076-2","article-title":"Multimodal non-invasive non-pharmacological therapies for chronic pain: mechanisms and progress","volume":"21","author":"Shi","journal-title":"BMC Med"},{"issue":"1","key":"R4","doi-asserted-by":"publisher","first-page":"92","DOI":"10.1002\/ejp.696","article-title":"Brain mechanisms of pain relief by transcutaneous electrical nerve stimulation: a functional magnetic resonance imaging study","volume":"20","author":"Choi","journal-title":"Eur J Pain"},{"issue":"5","key":"R5","doi-asserted-by":"publisher","first-page":"1053","DOI":"10.3233\/BMR-210146","article-title":"Transcutaneous electrical nerve stimulation effects on pain-intensity and endogenous opioids levels among chronic low-back pain patients: a randomised controlled trial","volume":"35","author":"Ezema","journal-title":"J Back Musculoskelet Rehabil"},{"issue":"10","key":"R6","doi-asserted-by":"publisher","first-page":"1332","DOI":"10.3390\/medicina58101332","article-title":"Using TENS for pain control: update on the state of the evidence","volume":"58","author":"Vance","journal-title":"Medicina (Kaunas)"},{"key":"R7","doi-asserted-by":"publisher","DOI":"10.2147\/JPR.S493162","article-title":"Latest advancements in transcutaneous electrical nerve stimulation (TENS) and electronic muscle stimulation (EMS): revisiting an established therapy with new possibilities","volume":"18","author":"Patel","journal-title":"J Pain Res"},{"issue":"4","key":"R8","doi-asserted-by":"publisher","first-page":"425","DOI":"10.1097\/AAP.0000000000000740","article-title":"Literature review and meta-analysis of transcutaneous electrical nerve stimulation in treating chronic back pain","volume":"43","author":"Wu","journal-title":"Reg Anesth Pain Med"},{"issue":"2","key":"R9","doi-asserted-by":"publisher","first-page":"127","DOI":"10.1093\/jmt\/thaa003","article-title":"The cognitive mechanisms in music listening interventions for pain: a scoping review","volume":"57","author":"Howlin","journal-title":"J Music Ther"},{"issue":"7","key":"R10","doi-asserted-by":"publisher","first-page":"1143","DOI":"10.1016\/j.jpain.2022.01.003","article-title":"Isn\u2019t there room for music in chronic pain management?","volume":"23","author":"Sihvonen","journal-title":"J Pain"},{"issue":"4","key":"R11","doi-asserted-by":"publisher","first-page":"430","DOI":"10.1093\/jmt\/thw012","article-title":"The effects of music on pain: a meta-analysis","volume":"53","author":"Lee","journal-title":"J Music Ther"},{"key":"R12","unstructured":"Guidance for the clinical use of electrophysical agents. Chartered Society of Physiotherapy; 2006. URL: https:\/\/cdm16198.contentdm.oclc.org\/digital\/collection\/p16198coll2\/id\/767\/ [Accessed 28-01-2026]"},{"issue":"3","key":"R13","doi-asserted-by":"publisher","first-page":"224","DOI":"10.1097\/AJP.0b013e31828dc828","article-title":"Implementation fidelity of self-administered transcutaneous electrical nerve stimulation (TENS) in patients with chronic back pain: an observational study","volume":"30","author":"Pallett","journal-title":"Clin J Pain"},{"issue":"1","key":"R14","doi-asserted-by":"publisher","first-page":"30","DOI":"10.2519\/jospt.2012.3727","article-title":"The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure","volume":"42","author":"Horn","journal-title":"J Orthop Sports Phys Ther"},{"issue":"1","key":"R15","doi-asserted-by":"publisher","first-page":"95","DOI":"10.1097\/MLR.0000000000001664","article-title":"Guidelines for designing and evaluating feasibility pilot studies","volume":"60","author":"Teresi","journal-title":"Med Care"},{"issue":"4","key":"R16","doi-asserted-by":"publisher","first-page":"283","DOI":"10.1016\/j.ejpain.2003.09.004","article-title":"Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale","volume":"8","author":"Salaffi","journal-title":"Eur J Pain"},{"issue":"3","key":"R17","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0229228","article-title":"Clinically significant changes in pain along the Pain Intensity Numerical Rating Scale in patients with chronic low back pain","volume":"15","author":"Suzuki","journal-title":"PLoS ONE"},{"issue":"2","key":"R18","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2021-051073","article-title":"Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study)","volume":"12","author":"Johnson","journal-title":"BMJ Open"},{"issue":"4 Suppl","key":"R19","doi-asserted-by":"publisher","first-page":"S114","DOI":"10.1097\/00002508-200112001-00020","article-title":"Biopsychosocial approaches to the treatment of chronic pain","volume":"17","author":"Nielson","journal-title":"Clin J Pain"},{"issue":"Suppl 1","key":"R20","doi-asserted-by":"publisher","first-page":"S3","DOI":"10.1097\/j.pain.0000000000002654","article-title":"The biopsychosocial model of pain 40 years on: time for a reappraisal?","volume":"163","author":"Nicholas","journal-title":"Pain"},{"issue":"4","key":"R21","doi-asserted-by":"publisher","DOI":"10.3390\/medicina57040378","article-title":"Resolving long-standing uncertainty about the clinical efficacy of transcutaneous electrical nerve stimulation (TENS) to relieve pain: a comprehensive review of factors influencing outcome","volume":"57","author":"Johnson","journal-title":"Medicina (Kaunas)"},{"issue":"10","key":"R22","doi-asserted-by":"publisher","first-page":"1060","DOI":"10.3390\/medicina57101060","article-title":"Does TENS reduce the intensity of acute and chronic pain? A comprehensive appraisal of the characteristics and outcomes of 169 reviews and 49 meta-analyses","volume":"57","author":"Paley","journal-title":"Medicina (Kaunas)"},{"issue":"1-2","key":"R23","doi-asserted-by":"publisher","first-page":"36","DOI":"10.1016\/j.pain.2003.10.013","article-title":"Pain reducing effect of three types of transcutaneous electrical nerve stimulation in patients with chronic pain: a randomized crossover trial","volume":"108","author":"K\u00f6ke","journal-title":"Pain"},{"key":"R24","doi-asserted-by":"crossref","unstructured":"Louis TA Philip WL Bailar JC Polansky M . Crossover and self-controlled designs in clinical research. In: Bailar JC Hoaglin DC , editors. Medical Uses of Statistics. 3rd ed. CRC Press; 2009:83-103. ISBN: 9780470439531","DOI":"10.1201\/9780429187445-5"},{"issue":"1","key":"R25","doi-asserted-by":"publisher","DOI":"10.1186\/s40359-025-02643-x","article-title":"The effect of music therapy for patients with chronic pain: systematic review and meta-analysis","volume":"13","author":"Chen","journal-title":"BMC Psychol"},{"issue":"6","key":"R26","doi-asserted-by":"publisher","first-page":"371","DOI":"10.1159\/000507400","article-title":"Prior therapeutic experiences, not expectation ratings, predict placebo effects: an experimental study in chronic pain and healthy participants","volume":"89","author":"Colloca","journal-title":"Psychother Psychosom"},{"key":"R27","doi-asserted-by":"publisher","DOI":"10.1016\/j.oor.2024.100662","article-title":"How to choose a sampling technique and determine sample size for research: a simplified guide for researchers","volume":"12","author":"Ahmed","journal-title":"Oral Oncology Reports"},{"key":"R28","doi-asserted-by":"publisher","DOI":"10.1186\/s40814-019-0493-7","article-title":"Should treatment effects be estimated in pilot and feasibility studies?","volume":"5","author":"Sim","journal-title":"Pilot Feasibility Stud"},{"key":"R29","doi-asserted-by":"publisher","DOI":"10.1136\/bmj-2024-083405","article-title":"Determining sample size for pilot trials: a tutorial","volume":"390","author":"Ying","journal-title":"BMJ"}],"container-title":["JMIR Research Protocols"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.researchprotocols.org\/2026\/1\/e82382","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T18:16:19Z","timestamp":1782843379000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchprotocols.org\/2026\/1\/e82382"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,24]]},"references-count":29,"URL":"https:\/\/doi.org\/10.2196\/82382","relation":{},"ISSN":["1929-0748"],"issn-type":[{"value":"1929-0748","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,24]]},"article-number":"v15i6e82382"}}