{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T17:47:35Z","timestamp":1782841655112,"version":"3.54.5"},"reference-count":32,"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 Few manual chiropractic high velocity, low amplitude (HVLA) type shams have been validated in research. The proposed project is a randomized controlled trial (RCT) designed to assess a novel, full-spine, manual sham chiropractic maneuver and its blinding success.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This study aims to evaluate the blinding integrity of participants receiving a genuine or sham chiropractic maneuver. We will also be evaluating the effects of genuine chiropractic treatments relative to sham chiropractic treatments by measuring several neurophysiological mechanisms.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n Participants (N=60) will be recruited from in and around Marietta, Georgia, United States. They will undergo a chiropractic physical exam and health history review with a licensed chiropractor and be randomized to either a sham or genuine chiropractic group (1:1 ratio). Participants, outcome assessors, and data analysts will be blinded to group allocation. The genuine group will receive diversified HVLA chiropractic spinal manipulative therapy (SMT), while the sham group will receive a novel chiropractic HVLA-emulating therapy. Each participant will attend 2 sessions spaced 1 week apart. Assessments will consist of blinding surveys postsessions (both visits) and presession (second visit). Additionally, we will measure gait parameters. The primary outcome of interest is blinding measured via the Bang Blinding Index (Bang BI). Secondary aims include measuring blinding via the James Blinding Index (James BI) and exploring the potential differential effects of genuine versus sham SMT on gait parameters.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n This study is being supported and internally funded by the Dr. Sid E. Williams Center for Chiropractic Research at Life University in Marietta, Georgia, United States. Our study was prospectively registered on clinicaltrials.gov (NCT06931600) on March 28, 2025, and the first participant was enrolled on May 5, 2025. As of December 10, 2025, 18 participants have completed the trial. Projections for completing data collection, data analysis, and manuscript submission are Summer 2026, Fall 2026, and Winter 2027, respectively.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The significance of the current RCT will be in its ability to inform whether our novel, full-spine, manual sham SMT protocol successfully blinds participants, suggesting feasibility for future clinical trials, as well as assessing for secondary outcome measures between groups.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/85956","type":"journal-article","created":{"date-parts":[[2025,12,27]],"date-time":"2025-12-27T10:45:06Z","timestamp":1766832306000},"page":"e85956-e85956","source":"Crossref","is-referenced-by-count":0,"title":["Spinal Manipulative Therapy on a Healthy Population: Protocol for a Randomized Blinding Feasibility Trial"],"prefix":"10.2196","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-7969-2495","authenticated-orcid":false,"given":"Margaret","family":"Sliwka","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3054-5928","authenticated-orcid":false,"given":"Tyson","family":"Perez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7597-254X","authenticated-orcid":false,"given":"Ahmed","family":"Qazi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0285-0028","authenticated-orcid":false,"given":"Stephanie","family":"Sullivan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,3,27]]},"reference":[{"issue":"5","key":"R1","first-page":"345","volume":"53","author":"Karanicolas","journal-title":"Can J Surg"},{"key":"R2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijosm.2021.10.003","article-title":"Overcoming placebo-related challenges in manual therapy trials: the \u2018whats and hows\u2019 and the \u2018touch equality assumption\u2019 proposals","volume":"42","author":"D\u2019Alessandro","journal-title":"Int J Osteopath Med"},{"issue":"1","key":"R3","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1080\/10669817.2025.2448921","article-title":"Sham treatment? Should it be redefined for its use in manual therapy clinical studies?","volume":"33","author":"Hage","journal-title":"J Man Manip Ther"},{"issue":"5","key":"R4","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2020-045106","article-title":"Sham treatment effects in manual therapy trials on back pain patients: a systematic review and pairwise meta-analysis","volume":"11","author":"Lavazza","journal-title":"BMJ Open"},{"issue":"2","key":"R5","doi-asserted-by":"publisher","first-page":"135","DOI":"10.1016\/s0004-9514(06)70049-6","article-title":"Selecting an appropriate placebo for a trial of spinal manipulative therapy","volume":"52","author":"Hancock","journal-title":"Aust J Physiother"},{"issue":"1","key":"R6","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1186\/2045-709X-19-3","article-title":"Systematic review of clinical trials of cervical manipulation: control group procedures and pain outcomes","volume":"19","author":"Vernon","journal-title":"Chiropr Man Therap"},{"issue":"1","key":"R7","doi-asserted-by":"publisher","first-page":"59","DOI":"10.1016\/j.jbmt.2012.06.005","article-title":"The suitability of sham treatments for use as placebo controls in trials of spinal manipulative therapy: a pilot study","volume":"17","author":"Lougee","journal-title":"J Bodyw Mov Ther"},{"issue":"7","key":"R8","doi-asserted-by":"publisher","first-page":"889","DOI":"10.1007\/s00586-008-0664-3","article-title":"Imperfect placebos are common in low back pain trials: a systematic review of the literature","volume":"17","author":"Machado","journal-title":"Eur Spine J"},{"issue":"3","key":"R9","doi-asserted-by":"publisher","first-page":"445","DOI":"10.1016\/j.spinee.2016.11.003","article-title":"The quality of placebos used in randomized, controlled trials of lumbar and pelvic joint thrust manipulation-a systematic review","volume":"17","author":"Puhl","journal-title":"Spine J"},{"issue":"3","key":"R10","doi-asserted-by":"publisher","first-page":"165","DOI":"10.1016\/j.jcm.2016.04.014","article-title":"Spinal manipulation vs sham manipulation for nonspecific low back pain: a systematic review and meta-analysis","volume":"15","author":"Ruddock","journal-title":"J Chiropr Med"},{"issue":"1","key":"R11","doi-asserted-by":"publisher","first-page":"21","DOI":"10.1089\/107555302753507159","article-title":"Issues in planning a placebo-controlled trial of manual methods: results of a pilot study","volume":"8","author":"Hawk","journal-title":"J Altern Complement Med"},{"issue":"4","key":"R12","doi-asserted-by":"publisher","first-page":"879","DOI":"10.1016\/s0885-3924(01)00337-2","article-title":"Spinal manipulation: a systematic review of sham-controlled, double-blind, randomized clinical trials","volume":"22","author":"Ernst","journal-title":"J Pain Symptom Manage"},{"issue":"2","key":"R13","doi-asserted-by":"publisher","first-page":"42","DOI":"10.3109\/10601331003777444","article-title":"Blinding assessment in clinical trials: a review of statistical methods and a proposal of blinding assessment protocol","volume":"27","author":"Bang","journal-title":"Clin Res Regul Aff"},{"issue":"5","key":"R14","doi-asserted-by":"publisher","first-page":"479","DOI":"10.1177\/17407745231171647","article-title":"Success of blinding a procedural intervention in a randomised controlled trial in preterm infants receiving respiratory support","volume":"20","author":"Reid","journal-title":"Clin Trials"},{"issue":"1","key":"R15","doi-asserted-by":"publisher","DOI":"10.1186\/s40814-024-01492-6","article-title":"Feasibility of blinding spinal manual therapy interventions among participants and outcome assessors: protocol for a blinding feasibility trial","volume":"10","author":"Mu\u00f1oz Laguna","journal-title":"Pilot Feasibility Stud"},{"issue":"1","key":"R16","doi-asserted-by":"publisher","DOI":"10.1186\/s12998-024-00561-0","article-title":"\u201cWhich treatment do you believe you received?\u201d A randomised blinding feasibility trial of spinal manual therapy","volume":"33","author":"Mu\u00f1oz Laguna","journal-title":"Chiropr Man Therap"},{"issue":"10","key":"R17","doi-asserted-by":"publisher","first-page":"437","DOI":"10.1515\/jom-2023-0203","article-title":"Effect of manual manipulation on mechanical gait parameters","volume":"124","author":"Yanuck","journal-title":"J Osteopath Med"},{"issue":"1","key":"R18","doi-asserted-by":"publisher","DOI":"10.1186\/s12998-024-00539-y","article-title":"Waste not, want not: call to action for spinal manipulative therapy researchers","volume":"32","author":"Aspinall","journal-title":"Chiropr Man Therap"},{"issue":"3","key":"R19","doi-asserted-by":"publisher","first-page":"160","DOI":"10.2519\/jospt.2006.36.3.160","article-title":"Methodological quality of randomized controlled trials of spinal manipulation and mobilization in tension-type headache, migraine, and cervicogenic headache","volume":"36","author":"Fern\u00e1ndez-de-las-Pe\u00f1as","journal-title":"J Orthop Sports Phys Ther"},{"key":"R20","unstructured":"Bergmann TF Peterson DH . Chiropractic Technique: Principles and Procedures. 3rd ed. Mosby; 2010. ISBN: 9780323049696"},{"key":"R21","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.g1687","article-title":"Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide","volume":"348","author":"Hoffmann","journal-title":"BMJ"},{"issue":"2","key":"R22","doi-asserted-by":"publisher","first-page":"143","DOI":"10.1016\/j.cct.2003.10.016","article-title":"Assessment of blinding in clinical trials","volume":"25","author":"Bang","journal-title":"Control Clin Trials"},{"key":"R23","doi-asserted-by":"publisher","DOI":"10.1016\/j.conctc.2016.05.003","article-title":"Random guess and wishful thinking are the best blinding scenarios","volume":"3","author":"Bang","journal-title":"Contemp Clin Trials Commun"},{"key":"R24","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.b3985","article-title":"The tyranny of power: is there a better way to calculate sample size?","volume":"339","author":"Bland","journal-title":"BMJ"},{"key":"R25","unstructured":"R Core Team. R: a language and environment for statistical computing (version 4.5.1). R Foundation for Statistical Computing. 2024. URL: https:\/\/www.R-project.org [Accessed 09-02-2026]"},{"key":"R26","doi-asserted-by":"crossref","unstructured":"Schwartz M Mercaldo N . BI: blinding assessment indexes for randomized, controlled, clinical trials. R package ver100. 2021. URL: https:\/\/cran.r-project.org\/web\/packages\/BI\/index.html [Accessed 28-02-2026]","DOI":"10.32614\/CRAN.package.BI"},{"issue":"1","key":"R27","doi-asserted-by":"publisher","first-page":"1","DOI":"10.18637\/jss.v067.i01","article-title":"Fitting linear mixed-effects models using lme4","volume":"67","author":"Bates","journal-title":"J Stat Softw"},{"key":"R28","doi-asserted-by":"crossref","unstructured":"Chakraborty H Gu H . A Mixed Model Approach for Intent-to-Treat Analysis in Longitudinal Clinical Trials with Missing Values. RTI Press; 2009. [doi: 10.3768\/rtipress.2009.mr.0009.0903]","DOI":"10.3768\/rtipress.2009.mr.0009.0903"},{"issue":"5","key":"R29","doi-asserted-by":"publisher","first-page":"1876","DOI":"10.3758\/s13428-020-01520-2","article-title":"A graph for every analysis: mapping visuals onto common analyses using flexplot","volume":"53","author":"Fife","journal-title":"Behav Res Methods"},{"issue":"4","key":"R30","doi-asserted-by":"publisher","first-page":"477","DOI":"10.1037\/met0000424","article-title":"Flexplot: graphically-based data analysis","volume":"27","author":"Fife","journal-title":"Psychol Methods"},{"key":"R31","unstructured":"Lenth R . Emmeans: estimated marginal means, aka least-squares means. R package version 185. 2023. URL: https:\/\/CRAN.R-project.org\/package=emmeans [Accessed 28-02-2026]"},{"issue":"5","key":"R32","doi-asserted-by":"publisher","first-page":"531","DOI":"10.1016\/j.math.2008.09.001","article-title":"The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model","volume":"14","author":"Bialosky","journal-title":"Man Ther"}],"container-title":["JMIR Research Protocols"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.researchprotocols.org\/2026\/1\/e85956","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T17:14:02Z","timestamp":1782839642000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchprotocols.org\/2026\/1\/e85956"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,27]]},"references-count":32,"URL":"https:\/\/doi.org\/10.2196\/85956","relation":{},"ISSN":["1929-0748"],"issn-type":[{"value":"1929-0748","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,27]]},"article-number":"v15i5e85956"}}