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Acute Effect of Topical Menthol on Carpal Tunnel Syndrome (IRMA)

This study is not yet open for participant recruitment.
Verified December 2012 by National Research Centre for the Working Environment, Denmark
Sponsor:
Collaborator:
Marquette University
Information provided by (Responsible Party):
Lars L. Andersen, National Research Centre for the Working Environment, Denmark
ClinicalTrials.gov Identifier:
NCT01716767
First received: October 23, 2012
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

Topical menthol gels are classified 'topical analgesics' and are used to relieve pain of the musculoskeletal system. However, double-blind randomized controlled trials are lacking. Here the investigators examine - in a double-blind randomized controlled cross-over trial - the acute effect of topical menthol (Biofreeze) and placebo (gel with a menthol scent) on pain symptoms in slaughterhouse workers with symptoms of Carpal Tunnel Syndrome.


Condition Intervention
Carpal Tunnel Syndrome
 Other: Menthol
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Effect of Topical Menthol on Pain Symptoms in Slaughterhouse Workers With Symptoms of Carpal Tunnel Syndrome: Randomized Controlled Trial

Resource links provided by NLM:

Drug Information available for: Menthol
U.S. FDA Resources

Further study details as provided by National Research Centre for the Working Environment, Denmark:

Primary Outcome Measures:
  • Change in arm/hand pain intensity (scale 0-10) during work [ Time Frame: change from before to after (average of 1,2 and 3 hours after) application of the gel ] [ Designated as safety issue: No ]
    the participant rates "pain intensity during the last hour" on a scale from 0-10 immediately before, and 1,2,3 hours after application of the gel. The primary outcome is the change from before to after (average of 1,2 and 3 hours after) application of the gel


Secondary Outcome Measures:
  • GROC [ Time Frame: 3 hours after application of the gel ] [ Designated as safety issue: No ]
    Global Rating of Change (GROC) on a scale from - 5(much worsening of pain) to 5(much improvement of pain)


Estimated Enrollment: 16
Study Start Date: December 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Menthol
Biofreeze topical gel containing 3.5% menthol
 Other: Menthol
The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm
Other Name: Topical analgesic
Placebo Comparator: Placebo
Topical gel containing a menthol scent, but no active menthol
 Other: Placebo
The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • positive Phalen test
  • positive Tinel test
  • nocturnal hand/wrist pain
  • pain intensity of at least 4 in the hand/wrist
  • the pain should have lasted at least 3 months

Exclusion Criteria:

  • pregnancy
  • life-threatening disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716767

Contacts
Contact: Lars Andersen, PhD 4539165319 lla@nrcwe.dk

Locations
Denmark
National Research Centre for the Working Environment Not yet recruiting
Copenhagen, Denmark, 2100
Contact: Lars L Andersen, PhD     39165319 ext 0045     lla@nrcwe.dk    
Sponsors and Collaborators
National Research Centre for the Working Environment, Denmark
Marquette University
Investigators
Principal Investigator: Lars L Andersen, PhD Senior Researcher
  More Information

No publications provided

Responsible Party: Lars L. Andersen, Principal Investigator, National Research Centre for the Working Environment, Denmark
ClinicalTrials.gov Identifier: NCT01716767     History of Changes
Other Study ID Numbers: IRMA07
Study First Received: October 23, 2012
Last Updated: December 5, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by National Research Centre for the Working Environment, Denmark:
Carpal tunnel syndrome
hand pain
wrist pain
arm pain
topical menthol

Additional relevant MeSH terms:
Cumulative Trauma Disorders
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
 Sprains and Strains
Wounds and Injuries
Menthol
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013