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Evaluating the effect of a combined therapy of chiropractic sessions plus nutritional supplement containing hemp, omega-3 fatty acids, and broccoli extract oil in patients experiencing chronic pain and inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants consume 1 serving of Placebo daily and attend weekly chiropractor sessions for 12 weeks. |
|
| Treatment Group | Experimental | Participants consume 1 serving of the Nutrional supplement daily and attend weekly chiropractor sessions for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional Supplement | Dietary Supplement | Nutritional Supplement + Chiropract sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Pain level using the Brief Pain Inventory (BPI) after 12 weeks. | The BPI is a validated self-reporting instrument assessing pain. Possible score range 0-10 with higher scores indicating higher pain levels. The instrument contains 9 items. | Baseline and 12 weeks |
| Change from baseline in Pain intensity using the 11-Point Numeric Rating Scale (11-NRS) after 12 weeks. | The 11-NRS is a validated self-reporting instrument assessing pain level. Possible score ranges from '0' representing "no pain" to '10' representing "worst pain imaginable". | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reactive oxygen species (ROS) status | Reactive oxygen species (ROS) status in the peripheral blood mononuclear cells was used to assess participant's inflammation biomarkers. | At baseline and after 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Randolph Chiropractic Health Center | Charlotte | North Carolina | 28207 | United States | ||
| Trull Chiropractic PA |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Placebo | Other | Placebo + Chiropractic sessions |
|
|
| Kannapolis |
| North Carolina |
| 28083 |
| United States |
| Combined Chiropractic & Acupuncture PLLC | Mooresville | North Carolina | 28117 | United States |