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Arnica in a topical gel formulation will be compared to a placebo to determine whether it decreases muscle soreness following leg exercise when applied to the legs.
Design: The design is a randomized, placebo-controlled, double-blind trial. Each participant will receive 2 containers of gel. One container will be marked "LEFT" and one "RIGHT." One container will contain a commercially available arnica gel formulation, and the other will contain a placebo gel, identical in appearance to the arnica. Subjects will not know which container contains which product. Each participant will also be given a form containing an analog pain scale for each leg. The participant will rate his or her pain in each leg separately on the day before exercise. Each subject will then be asked to perform calf raises using the following protocol:
Neither subjects nor the researchers doing the data collection or analysis will know which gel is associated with which formulation (placebo vs. Arnica). Controls are within-subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | arnica containing cream |
|
| 2 | Placebo Comparator | carrier cream without arnica |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arnica Montana | Drug | Applied to lower extremity once a day for 3 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle soreness | 24 - 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle tenderness | 48 hours | |
| Range of motion of ankle joint | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W Bauer, MD | Memorial Hermann | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Family Medicine | Houston | Texas | 77074 | United States |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D063806 | Myalgia |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| C000712347 | Arnicae flos extract |
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| placebo cream |
| Drug |
placebo cream applied to leg daily for 3 days |
|
| D009422 |
| Nervous System Diseases |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |