Spinal Manipulative Therapy on a Healthy Population: Protocol for a Randomized Blinding Feasibility Trial
Bibliographic record
Abstract
Background: 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. Objective: 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. Methods: 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. Results: 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. 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 participants, suggesting feasibility for future clinical trials, as well as assessing for secondary outcome measures between groups.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.055 | 0.049 |
| Meta-epidemiology (narrow) | 0.007 | 0.004 |
| Meta-epidemiology (broad) | 0.011 | 0.004 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.005 | 0.004 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.004 | 0.003 |
| Research integrity | 0.009 | 0.010 |
| Insufficient payload (model declined to judge) | 0.102 | 0.023 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".