Patient Perceptions and Experiences Following Multiple Sessions of Simulated or Genuine HVLA Manual Chiropractic Adjustments

Study Purpose

Our primary aim with this trial is to measure participant blinding following two simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments to assess if participants are able to identify their un-disclosed treatment group. Our secondary aims with this trial are to utilize electrocardiography (ECG), impedance cardiography (ICG), and gait analysis before either treatment session and after both treatment sessions to assess if there are any changes with the participants' measurements before and after a sham or genuine HVLA chiropractic treatment.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 60 Years
Gender	All

More Inclusion & Exclusion Criteria

- No history of stroke or transient ischemic attack or current symptoms including: Dizziness or vertigo; Tinnitus (ringing in the ears); Visual, sensory, or motor disturbances.

- No new pattern headache complaint.

- No recent whiplash injury (within 3 mo) - No spinal fractures/dislocations.

- No disc problems with radiating symptoms to the arms or legs.

- No severe degenerative joint disease in the spine.

- No connective tissue disorders.

- No primary fibromyalgia.

- No metabolic or metaplastic bone disease.

- No history of cervical, thoracic, or lumbar spine surgery.

- No uncontrolled high blood pressure or vascular disease.

- No current use of anticoagulant therapy.

- Not a DC or a DC student enrolled 4th quarter or above.

- No present, self-reported pregnancy.

- No chiropractic care in the 2 weeks prior to participation.

- Did not participate in the feasibility study for this pilot (Perceptions and experiences following a single session of simulated or genuine high velocity, low amplitude (HVLA) manual chiropractic adjustments)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06931600
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Life University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Margaret Sliwka, DC
Principal Investigator Affiliation	Life University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Subluxation

Additional Details

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, 60 eligible participants will be randomized (1:1 ratio) to receive two sessions of either simulated/sham or genuine/real chiropractic spinal adjustments with a 1 week washout between each treatment. The participants will be given a brief survey immediately following their first and second sessions, as well as immediately prior to the second session. This survey captures their perceptions and experiences regarding the intervention they received. The participants will also complete a pre- and post-electrocardiogram (ECG), impedance cardiography (ICG), and gait analysis. The participant will wear electrical diodes to assess ECG and ICG. Additional sensors will be placed on the participant to assess gait patterns while walking on a treadmill.

Arms & Interventions

Arms

Sham Comparator: Simulated/sham

30 individuals receiving simulated/sham chiropractic interventions

Experimental: Genuine/real

30 individuals receiving genuine/real chiropractic interventions

Interventions

Procedure: - Sham adjustment

Two manual high velocity, low amplitude (HVLA) simulated/sham chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions

Procedure: - Chiropractic adjustment

Two manual high velocity, low amplitude (HVLA) genuine/real chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Marietta 4207783, Georgia 4197000

Status

Recruiting

Address

Dr. Sid E. Williams Center for Chiropractic Research

Marietta 4207783, Georgia 4197000, 30067

Site Contact

Daekiara Smith-Ireland, MPH

[email protected]

770-426-2639

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