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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 17, 2007
First Posted Date  ICMJE July 19, 2007
Last Update Posted Date January 7, 2009
Study Start Date  ICMJE August 2007
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2007)
Muscle soreness [ Time Frame: 24 - 72 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2007)
  • Muscle tenderness [ Time Frame: 48 hours ]
  • Range of motion of ankle joint [ Time Frame: 48 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Role of Arnica on Muscle Pain Following Eccentric Exercise
Official Title  ICMJE The Role of Arnica on Muscle Pain Following Eccentric Exercise
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Muscles
  • Exercise
  • Arnica
Intervention  ICMJE
  • Drug: Arnica Montana
    Applied to lower extremity once a day for 3 days
  • Drug: placebo cream
    placebo cream applied to leg daily for 3 days
Study Arms  ICMJE
  • Active Comparator: 1
    arnica containing cream
    Intervention: Drug: Arnica Montana
  • Placebo Comparator: 2
    carrier cream without arnica
    Intervention: Drug: placebo cream
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2009)
55
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2007)
100
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00504010
Other Study ID Numbers  ICMJE HSC-MH-07-0202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David W. Bauer, MD, Memorial Hermann Healthcare System
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David W Bauer, MD Memorial Hermann
PRS Account The University of Texas Health Science Center, Houston
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP