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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
60
Two manual high velocity, low amplitude (HVLA) simulated/sham chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions
Two manual high velocity, low amplitude (HVLA) genuine/real chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions
Dr. Sid E. Williams Center for Chiropractic Research
Marietta, Georgia, United States
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.
Time frame: Immediately post-session 1 (day 1)
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.
Time frame: Immediately pre-session 2 (day 2)
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.
Time frame: Immediately post-session 2 (day 2)
High-frequency Heart Rate Variability (HF-HRV)
3 sensors on torso. HF-HRV indexes fluctuations in the heart period that occur within the 0.12 to 0.5 Hz frequency range
Time frame: baseline
High-frequency Heart Rate Variability (HF-HRV)
3 sensors on torso. HF-HRV indexes fluctuations in the heart period that occur within the 0.12 to 0.5 Hz frequency range.
Time frame: post-session 2 (day 2)
Pre-ejection period (PEP)
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).
Time frame: baseline
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Pre-ejection period (PEP)
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).
Time frame: post-session 2 (day 2)
The speed of the participants will be assessed at baseline as part of the gait analysis.
16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements
Time frame: baseline
The speed of the participants will be assessed again at post-session 2 as part of the gait analysis.
16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements
Time frame: post-session 2 (day 2)
Force measurements generated during walking will be assessed at baseline as part of the gait analysis.
16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements
Time frame: baseline
Force measurements generated during walking will be assessed again at post-session 2 as part of the gait analysis.
16 inertial measurement unit (IMU) sensors (noraxon) and treadmill output measurements
Time frame: post-session 2 (day 2)
Gait symmetry will be assessed at baseline as part of the gait analysis.
16 inertial measurement unit (IMU) sensors (noraxon)
Time frame: baseline
Gait symmetry will be assessed again at post-session 2 as part of the gait analysis.
16 inertial measurement unit (IMU) sensors (noraxon)
Time frame: post-session 2 (day 2)
Root Mean Square of Successive Differences (RMSSD)
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.
Time frame: baseline
Root Mean Square of Successive Differences (RMSSD)
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.
Time frame: post-session 2 (day 2)