Clinical trial NCT06931600: Patient Perceptions and Experiences Following Multiple Sessions of Simulated or Genuine HVLA Manual Chiropractic Adjustments
Official title: Blinding Integrity Following Multiple Sessions of Simulated or Genuine High Velocity, Low Amplitude (HVLA) Manual Chiropractic Adjustments: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Subluxation
Keywords: randomized
sham-controlled
chiropractic
blinding
gait analysis
impedance cardiography
movement parameters
electrocardiography
autonomic nervous system
Heart Rate Variability
Lead sponsor: Life University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, sham-controlled, pilot study
Primary purpose: OTHER

Brief summary: 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.

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, 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.

Eligibility 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)

Primary outcomes:
measure: Participant blinding
timeFrame: Immediately post-session 1 (day 1)
measure: Participant blinding
timeFrame: Immediately pre-session 2 (day 2)
measure: Participant blinding
timeFrame: Immediately post-session 2 (day 2)
Secondary outcomes:
measure: High-frequency Heart Rate Variability (HF-HRV)
timeFrame: baseline
measure: High-frequency Heart Rate Variability (HF-HRV)
timeFrame: post-session 2 (day 2)
measure: Pre-ejection period (PEP)
timeFrame: baseline
measure: Pre-ejection period (PEP)
timeFrame: post-session 2 (day 2)
measure: The speed of the participants will be assessed at baseline as part of the gait analysis.
timeFrame: baseline
measure: The speed of the participants will be assessed again at post-session 2 as part of the gait analysis.
timeFrame: post-session 2 (day 2)
measure: Force measurements generated during walking will be assessed at baseline as part of the gait analysis.
timeFrame: baseline
measure: Force measurements generated during walking will be assessed again at post-session 2 as part of the gait analysis.
timeFrame: post-session 2 (day 2)
measure: Gait symmetry will be assessed at baseline as part of the gait analysis.
timeFrame: baseline
measure: Gait symmetry will be assessed again at post-session 2 as part of the gait analysis.
timeFrame: post-session 2 (day 2)
measure: Root Mean Square of Successive Differences (RMSSD)
timeFrame: baseline
measure: Root Mean Square of Successive Differences (RMSSD)
timeFrame: post-session 2 (day 2)
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Dr. Sid E. Williams Center for Chiropractic Research
state: Georgia
Study officials:
affiliation: Life University
name: Margaret Sliwka, DC
role: PRINCIPAL_INVESTIGATOR
References: