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The Role of Arnica on Muscle Pain Following Eccentric Exercise (Arnica)

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ClinicalTrials.gov Identifier: NCT00504010
Recruitment Status : Completed
First Posted : July 19, 2007
Last Update Posted : January 7, 2009
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston

Study Description
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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.

Condition or disease Intervention/treatment Phase
Muscles Exercise Arnica Drug: Arnica Montana Drug: placebo cream Phase 1

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Arnica on Muscle Pain Following Eccentric Exercise
Study Start Date : August 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
arnica containing cream
 Drug: Arnica Montana
Applied to lower extremity once a day for 3 days
Placebo Comparator: 2
carrier cream without arnica
 Drug: placebo cream
placebo cream applied to leg daily for 3 days


Outcome Measures
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Primary Outcome Measures :
  1. Muscle soreness [ Time Frame: 24 - 72 hours ]

Secondary Outcome Measures :
  1. Muscle tenderness [ Time Frame: 48 hours ]
  2. Range of motion of ankle joint [ Time Frame: 48 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504010


Locations
United States, Texas
Memorial Family Medicine
Houston, Texas, United States, 77074
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: David W Bauer, MD Memorial Hermann
More Information
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Responsible Party: David W. Bauer, MD, Memorial Hermann Healthcare System
ClinicalTrials.gov Identifier: NCT00504010     History of Changes
Other Study ID Numbers: HSC-MH-07-0202
First Posted: July 19, 2007    Key Record Dates
Last Update Posted: January 7, 2009
Last Verified: January 2009

Keywords provided by The University of Texas Health Science Center, Houston:
arnica
muscle soreness
exercise
eccentric

Additional relevant MeSH terms:
Myalgia
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms