The Role of Arnica on Muscle Pain Following Eccentric Exercise (Arnica)
Primary Purpose
Muscles, Exercise, Arnica
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Arnica Montana
placebo cream
Sponsored by
About this trial
This is an interventional treatment trial for Muscles focused on measuring arnica, muscle soreness, exercise, eccentric
Eligibility Criteria
Inclusion Criteria:
- age 18 or older
- two fully functional legs
Exclusion Criteria:
- allergy or sensitivity to the ester family
- open wound or inflammatory condition on legs
- chronic or acute leg pain
- neuropathy involving one or both legs
Sites / Locations
- Memorial Family Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
arnica containing cream
carrier cream without arnica
Outcomes
Primary Outcome Measures
Muscle soreness
Secondary Outcome Measures
Muscle tenderness
Range of motion of ankle joint
Full Information
NCT ID
NCT00504010
First Posted
July 17, 2007
Last Updated
January 6, 2009
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT00504010
Brief Title
The Role of Arnica on Muscle Pain Following Eccentric Exercise
Acronym
Arnica
Official Title
The Role of Arnica on Muscle Pain Following Eccentric Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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:
The participant removes shoes.
Active range of motion of the ankle is measured bilaterally using a goniometer.
He or she places the metatarsal portion of his or her foot on a step that is 7 inches above the floor. Handrails are provided for safety and comfort
He or she then performs heel lifts by rising up on the stair using the foot on the stair, holds this for 2 seconds, then maximally dorsiflexes the foot for a count of 2 seconds. A metronome set to generate a tone every 2 seconds guides the pace of this.
This is repeated 25 times, or until the subject is unable to complete a full cycle.
He or she then performs the same sequence using the other leg.
A second set of 20 repetitions is performed in each leg, followed by a final 15 repetitions.
The gel is applied immediately after exercise to both lower legs. Subjects are instructed not to wash off the leg for at least one hour after application.
The pain score is completed for each leg 24 hours later, and the gel is applied to each leg. Again, subjects are instructed to leave the gel undisturbed for at least one hour.
Approximately 48 hours later the subject returns for measurement of ankle range of motion, again completes a pain score and applies the gel for a final time. Subjects are instructed to leave the gel on the legs for at least one hour.
To measure muscle tenderness, a 1cm sphere is placed on the subject's mid-calf, and compressed by a standardized 5 pound weight. The subject provides a tenderness score for each leg using the same pain score.
A final pain score is completed by each subject at approximately 72 hours.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscles, Exercise, Arnica
Keywords
arnica, muscle soreness, exercise, eccentric
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
arnica containing cream
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
carrier cream without arnica
Intervention Type
Drug
Intervention Name(s)
Arnica Montana
Intervention Description
Applied to lower extremity once a day for 3 days
Intervention Type
Drug
Intervention Name(s)
placebo cream
Intervention Description
placebo cream applied to leg daily for 3 days
Primary Outcome Measure Information:
Title
Muscle soreness
Time Frame
24 - 72 hours
Secondary Outcome Measure Information:
Title
Muscle tenderness
Time Frame
48 hours
Title
Range of motion of ankle joint
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18 or older
two fully functional legs
Exclusion Criteria:
allergy or sensitivity to the ester family
open wound or inflammatory condition on legs
chronic or acute leg pain
neuropathy involving one or both legs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Bauer, MD
Organizational Affiliation
Memorial Hermann
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Family Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
12. IPD Sharing Statement
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The Role of Arnica on Muscle Pain Following Eccentric Exercise
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