Spinal Manipulative Therapy on a Healthy Population: Protocol for a Randomized Blinding Feasibility Trial

Area of Science:

• Chiropractic Research
• Clinical Trials
• Neurophysiology

Background:

• Limited research exists on validated manual chiropractic high-velocity, low-amplitude (HVLA) sham techniques.
• A novel full-spine, manual sham chiropractic maneuver has been developed.

Purpose of the Study:

• To evaluate the blinding integrity of participants receiving genuine or sham chiropractic maneuvers.
• To assess the neurophysiological effects of genuine versus sham chiropractic treatments.
• To determine the feasibility of a novel sham protocol for future clinical trials.

Main Methods:

• A randomized controlled trial (RCT) involving 60 participants in Marietta, Georgia.
• Participants were randomized (1:1) to receive either genuine diversified HVLA spinal manipulative therapy (SMT) or a novel HVLA-emulating sham therapy.
• Blinding was assessed using the Bang Blinding Index (Bang BI) and James Blinding Index (James BI), with gait parameters as secondary outcomes.

Main Results:

• The study is ongoing, with 18 of 60 participants enrolled as of December 10, 2025.
• Data collection is projected for completion in Summer 2026, with analysis and manuscript submission in Fall 2026 and Winter 2027, respectively.

Conclusions:

• The study's significance lies in determining the success of the novel sham SMT protocol in blinding participants.
• Findings will inform the feasibility of this sham protocol for future chiropractic clinical trials.
• Secondary outcomes will explore differential effects of genuine versus sham SMT on gait parameters.