Subluxation
Conditions
Keywords
randomized, sham-controlled, chiropractic, blinding
Brief summary
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
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.
Interventions
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)
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)
Sponsors
Study design
Masking description
Single-blinded
Intervention model description
Randomized, sham-controlled, proof-of-concept trial
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant blinding | Immediately after intervention | 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. |
Countries
United States