Patient Perceptions Following a Single Session of Simulated or Genuine HVLA Manual Chiropractic Adjustments

Study Overview
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Brief Summary
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The primary aim of this trial is to assess blinding following simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments.

Detailed Description
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The primary aim of this trial is to assess blinding following simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments. Briefly, 30 eligible participants will be randomized (1:1 ratio) to receive a single session of either simulated/sham or genuine/real chiropractic spinal adjustments and be given a brief survey immediately following their session and 48 hours later that captures their perceptions and experiences regarding the intervention they received. This study is intended to inform a future multi-session, randomized, sham-controlled trial.

Official Title
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Blinding Integrity Following a Single Session of Simulated or Genuine High Velocity, Low Amplitude (HVLA) Manual Chiropractic Adjustments: a Randomized Controlled Proof-of-concept Trial

Conditions
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Subluxation

Intervention / Treatment
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* Procedure: Chiropractic adjustment
* Procedure: Sham adjustment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-60 years of age Exclusion Criteria: History of stroke or transient ischemic attack or current symptoms including dizziness or vertigo, tinnitus (ringing in the ears), or visual, sensory, or motor disturbances New pattern headache complaint Recent whiplash injury (within 12 months) Cervical fracture/dislocation Disc problem with radiating symptoms to the arms or legs Severe degenerative joint disease in the spine Connective tissue disorder Primary fibromyalgia Metabolic or metaplastic bone disease History of cervical, thoracic, or lumbar spine surgery Uncontrolled high blood pressure or vascular disease Current use of anticoagulant therapy Doctor of Chiropractic (DC) or a DC student in 5th quarter or above Present, self-reported pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, sham-controlled, proof-of-concept trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genuine/real<br>15 participants receiving genuine/real chiropractic adjustment | Procedure: Chiropractic adjustment<br>* A single-session of genuine/real high-velocity, low-amplitude (HVLA) manual chiropractic adjustments to various regions of the spine (i.e., cervical, thoracic, lumbo-pelvic)<br>|
| Sham Comparator: Simulated/sham<br>15 participants receiving simulated/sham adjustment | Procedure: Sham adjustment<br>* A single-session of simulated/sham high-velocity, low-amplitude (HVLA) manual chiropractic adjustments to various regions of the spine (i.e., cervical, thoracic, lumbo-pelvic)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant blinding | The blinding index is scaled to an internal of -1 to +1, +1 being complete lack of blinding, 0 being consistent with perfect blinding, -1 indicating opposite guessing which may be related to unblinding. | Immediately after intervention | 
| Participant blinding | The blinding index is scaled to an internal of -1 to +1, +1 being complete lack of blinding, 0 being consistent with perfect blinding, -1 indicating opposite guessing which may be related to unblinding. | 48 hours after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized, sham-controlled, chiropractic, blinding