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

June 27, 2013 updated by: Lars L. Andersen, National Research Centre for the Working Environment, Denmark

Acute Effect of Topical Menthol on Pain Symptoms in Slaughterhouse Workers With Symptoms of Carpal Tunnel Syndrome: Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • National Research Centre for the Working Environment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
change from before to after (average of 1,2 and 3 hours after) application of the gel

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GROC
Time Frame: 3 hours after application of the gel
Global Rating of Change (GROC) on a scale from - 5(much worsening of pain) to 5(much improvement of pain)
3 hours after application of the gel

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Centre for the Working Environment, Denmark

Collaborators

Marquette University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (ESTIMATE)

October 30, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 28, 2013

Last Update Submitted That Met QC Criteria

June 27, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRMA07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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