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| Name | Class |
|---|---|
| Sport and Spine Rehab Clinical Research Foundation | OTHER |
| Parker University | OTHER |
| Brentwood Spine Clinic, Brentwood, MO, USA | UNKNOWN |
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The purpose of this multisite randomized controlled trial (RCT) is to compare the short-term (6 week) and long-term (6 month) effect of chiropractic care combined with a specific nutritional supplement regimen to chiropractic care with a placebo supplement for patients with ankle sprains, in terms of improvement in physical function and pain.
Specific Aim 1: to compare the short-term (6 week) effect of chiropractic care combined with a specific nutritional supplement regimen to chiropractic care with a placebo nutritional supplement for patients with ankle sprains, in terms of speed and amount of improvement in physical function and pain. Our hypothesis is that chiropractic care plus nutritional supplements designed to supply necessary nutrients for ligament healing will have improved outcomes in pain and disability, compared to chiropractic care plus placebo. We will use the Foot and Ankle Ability Measure Activities of Daily Living Subscale (FAAM ADLS) to measure outcomes.
Specific aim 2: to compare the long-term (6 month) effect of chiropractic care combined with a specific nutritional supplement regimen to chiropractic care with a placebo nutritional supplement for patients with ankle sprains, in terms of speed and amount of improvement in physical function and pain. Our hypothesis is that chiropractic care plus nutritional supplements designed to supply necessary nutrients for ligament healing will have improved outcomes as measured by the FAAM ADLS, compared to chiropractic care plus placebo.
Specific aim 3: to explore any changes in the attitude, knowledge and behavior of chiropractic interns and practitioners of the role of nutrition in treating musculoskeletal injuries, pre- and post-intervention. We will also compare their responses to those of a population of students and practitioners who did not participate in the project, as a comparison group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Acute phase (1st treatment through Week 4): Placebo. 2 capsules 3 x day. Chronic phase (Weeks 5-16): Placebo. 1 capsule 3 x day. |
|
| dietary supplement | Experimental | Acute phase (1st treatment through Week 4): Ligaplex 1. Ligaplex 1 supplies nutrients to support connective tissue and reduce inflammation. The protocol is commonly used in chiropractic practice and suggested by Standard Process: 2 capsules 3 x day. Chronic phase (Weeks 5-16): Glucosamine Synergy. This supplement maintains connective tissue and joint health. The protocol is commonly used in chiropractic practice and suggested by Standard Process: 1 capsule 3 x day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS) | baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Foot and Ankle Ability Measure (FAAM) Activities of Daily Living Subscale (ADLS) | baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl K Hawk, DC, PhD | Logan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sport and Spine Rehab | Columbia | Maryland | 21044 | United States | ||
| Sport and Spine Rehab |
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| Ft. Washington |
| Maryland |
| 20744 |
| United States |
| Sport and Spine Rehab | Landover | Maryland | 20785 | United States |
| Sport and Spine Rehab | Rockville | Maryland | 20852 | United States |
| Brentwood Spine Clinic | Brentwood | Missouri | 63144 | United States |
| Logan University | Chesterfield | Missouri | 63017 | United States |
| Sport and Spine Rehab | Fairfax | Virginia | 22030 | United States |
| Sport and Spine Rehab | McLean | Virginia | 22101 | United States |
| Sport and Spine Rehab | Sterling | Virginia | 20164 | United States |
| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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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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