Not provided
Not provided
Not provided
Not provided
Funding
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simulated/sham | Sham Comparator | 30 individuals receiving simulated/sham chiropractic interventions |
|
| Genuine/real | Experimental | 30 individuals receiving genuine/real chiropractic interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham adjustment | Procedure | Two manual high velocity, low amplitude (HVLA) simulated/sham chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Immediately post-session 2 (day 2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline |
| High-frequency Heart Rate Variability (HF-HRV) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tyson Perez, DC, PhD | Life University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Sid E. Williams Center for Chiropractic Research | Marietta | Georgia | 30067 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41894654 | Derived | Sliwka M, Perez T, Qazi A, Sullivan S. Spinal Manipulative Therapy on a Healthy Population: Protocol for a Randomized Blinding Feasibility Trial. JMIR Res Protoc. 2026 Mar 27;15:e85956. doi: 10.2196/85956. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D026882 | Manipulation, Chiropractic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
randomized, sham-controlled, pilot study
Not provided
Not provided
Lab coordinator
| Chiropractic adjustment | Procedure | Two manual high velocity, low amplitude (HVLA) genuine/real chiropractic interventions in the cervical, thoracic, and/or lumbopelvic regions |
|
3 sensors on torso. HF-HRV indexes fluctuations in the heart period that occur within the 0.12 to 0.5 Hz frequency range.
| 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). | baseline |
| 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). | 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 | 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 | 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 | 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 | 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) | baseline |
| Gait symmetry will be assessed again at post-session 2 as part of the gait analysis. | 16 inertial measurement unit (IMU) sensors (noraxon) | 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. | 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. | post-session 2 (day 2) |