Subluxation
Conditions
Keywords
randomized, sham-controlled, chiropractic, blinding, gait analysis, impedance cardiography, movement parameters, electrocardiography, autonomic nervous system, Heart Rate Variability
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.
Interventions
PROCEDURESham adjustment
Two manual high velocity, low amplitude (HVLA) simulated/sham chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions
PROCEDUREChiropractic adjustment
Two manual high velocity, low amplitude (HVLA) genuine/real chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions
Sponsors
Life University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Lab coordinator
Intervention model description
randomized, sham-controlled, pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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 diagnosed condition that causes fainting during postural changes, such as POTS or orthostatic hypotension * No history of cervical, thoracic, or lumbar spine surgery * No uncontrolled high blood pressure or vascular disease * No current use of anticoagulant therapy * No current use of short-acting benzodiazepines, including midazolam \& triazolam * No change in medications in the past 6 weeks or intentions to change medications during the study * Inability to walk unassisted on a treadmill * No pacemakers or known heart conditions that influence the electrical or mechanical function of the heart, such as severe heart valve disease * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant blinding | Immediately post-session 1 (day 1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High-frequency Heart Rate Variability (HF-HRV) | baseline | 3 sensors on torso. HF-HRV indexes fluctuations in the heart period that occur within the 0.12 to 0.5 Hz frequency range |
| Pre-ejection period (PEP) | baseline | 3 ECG sensors on the torso + 4 ICG sensors (2 sensors on chest and 2 sensors on back). The PEP is the time interval between the electrical depolarization of the heart (Q-wave on ECG) and the beginning of blood ejection from the heart (B-point on ICG). |
| The speed of the participants will be assessed at baseline as part of the gait analysis. | baseline | 16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements |
| The speed of the participants will be assessed again at post-session 2 as part of the gait analysis. | post-session 2 (day 2) | 16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements |
| Force measurements generated during walking will be assessed at baseline as part of the gait analysis. | baseline | 16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements |
| Force measurements generated during walking will be assessed again at post-session 2 as part of the gait analysis. | post-session 2 (day 2) | 16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements |
| Gait symmetry will be assessed at baseline as part of the gait analysis. | baseline | 16 inertial measurement unit (IMU) sensors (noraxon) |
| Gait symmetry will be assessed again at post-session 2 as part of the gait analysis. | post-session 2 (day 2) | 16 inertial measurement unit (IMU) sensors (noraxon) |
| Root Mean Square of Successive Differences (RMSSD) | baseline | 3 sensors on torso. RMSSD is a measure of heart rate variability (HRV) that focuses on short-term beat-to-beat changes in the heart period. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTyson Perez, DC, PhD
Life University
Outcome results
None listed