The Role of Arnica on Muscle Pain Following Eccentric Exercise

This study has been completed.
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00504010
First received: July 17, 2007
Last updated: January 6, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Muscles
Exercise
Arnica
Drug: Arnica Montana
Drug: placebo cream
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Arnica on Muscle Pain Following Eccentric Exercise

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Muscle soreness [ Time Frame: 24 - 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle tenderness [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Range of motion of ankle joint [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: August 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 17, 2007
Last Updated: January 6, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 14, 2014