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Reviewing protocol
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The project is a randomized, two-arm trial assessing the immediate impact of upper and lower cervical chiropractic adjustments on brain and heart patterns. Thirty individuals (15 per arm) will be recruited from the general population to participate in the study. Qualified participants will undergo a chiropractic physical exam, assessing for cervical subluxations, and a health history review with a Georgia licensed chiropractor. Individuals will be randomized to either an adjustment group or sham group. The adjustment group will receive an upper and lower cervical adjustment with an instrument designed to provide a gentle, targeted adjustment. The sham group will receive a touch sham at similar cervical locations with the same instrument. Both groups will have a 1-hour recording session with an EEG and ECG set-up plus a series of baseline recordings, interventions, and post recordings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjustment | Experimental | Individuals with a subluxation who receive a true chiropractic adjustment |
|
| Sham | Sham Comparator | Individuals with a subluxation who receive a light touch-only sham |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjustment | Procedure | Instrument-assisted, high velocity, low amplitude adjustment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| EEG resting state effective connectivity | Baseline EEG recording for the first intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG. | 0 minutes |
| EEG resting state effective connectivity | EEG recording immediately after the first intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG. | 8 minutes |
| EEG resting state effective connectivity | Baseline EEG recording for the second intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG. | 15 minutes |
| EEG resting state effective connectivity | EEG recording immediately after the second intervention or sham procedure. A 64-channel hydronet will be on the head to capture EEG. | 23 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| ECG R-R interval | Baseline recording for the first intervention or sham procedure. Three leads will on the torso to capture a Lead II ECG. | 0 minutes |
| ECG R-R interval | ECG recording immediately after the first intervention or sham procedure. Three leads will on the torso to capture a Lead II ECG. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Sullivan, DC, PhD | Life University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Sid E. Williams Center for Chiropractic Research | Marietta | Georgia | 30067 | United States |
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| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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Randomized, sham-controlled trial
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Blind to intervention
| Sham |
| Procedure |
Instrument-assisted light touch to neck |
|
| 8 minutes |
| ECG R-R interval | Baseline ECG recording for the second intervention or sham procedure. Three leads will on the torso to capture a Lead II ECG. | 15 minutes |
| ECG R-R interval | ECG recording immediately after the second intervention or sham procedure. Three leads will on the torso to capture a Lead II ECG. | 23 minutes |