JMIR Publications

ABSTRACT

Background:

Few manual chiropractic HVLA (High Velocity, Low Amplitude) 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.

Objective:

Our primary aim is 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.

Methods:

Subjects (n=60) will be recruited from in and around Marietta, GA, USA. 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). Subjects, 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 subject will attend two sessions spaced 1-week apart. Assessments will consist of blinding surveys post-sessions (both visits) and pre-session (second visit), as well as cardiac-related electrical and mechanical activity before, during, and after an orthostatic challenge, while also tracking 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 assessing the effects of SMT on electrocardiography (ECG)-derived heart rate variability (HRV), impedance cardiography (ICG)-derived pre-ejection period (PEP), and gait parameters.

Results:

This study is being supported and internally funded by the Dr. Sid E. Williams Center for Chiropractic Research at Life University in Marietta, GA, USA. Our study was prospectively registered on clinicaltrials.gov (NCT06931600) on March 28, 2025 and the first participant was seen on May 5, 2025. The study is scheduled to end on March 27, 2026, after which time data analysis will begin.

Conclusions:

The significance of the current RCT will be in its ability to inform whether our novel, full-spine, manual sham SMT protocol successfully blinds subjects rendering it feasible for future clinical trials, as well as assessing for secondary outcome measures between groups. Clinical Trial: Our study was prospectively registered on clinicaltrials.gov (NCT06931600) on 03/28/2025.