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

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Menthol
Placebo
Sponsored by
National Research Centre for the Working Environment, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal tunnel syndrome, hand pain, wrist pain, arm pain, topical menthol

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Research Centre for the Working Environment

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Menthol

Placebo

Arm Description

Biofreeze topical gel containing 3.5% menthol

Topical gel containing a menthol scent, but no active menthol

Outcomes

Primary Outcome Measures

Change in arm/hand pain intensity (scale 0-10) during work
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
Global Rating of Change (GROC) on a scale from - 5(much worsening of pain) to 5(much improvement of pain)

Full Information

First Posted
October 23, 2012
Last Updated
June 27, 2013
Sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
Marquette University
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1. Study Identification

Unique Protocol Identification Number
NCT01716767
Brief Title
Acute Effect of Topical Menthol on Carpal Tunnel Syndrome
Acronym
IRMA
Official Title
Acute Effect of Topical Menthol on Pain Symptoms in Slaughterhouse Workers With Symptoms of Carpal Tunnel Syndrome: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
Marquette University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal tunnel syndrome, hand pain, wrist pain, arm pain, topical menthol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Menthol
Arm Type
Experimental
Arm Description
Biofreeze topical gel containing 3.5% menthol
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Topical gel containing a menthol scent, but no active menthol
Intervention Type
Other
Intervention Name(s)
Menthol
Other Intervention Name(s)
Topical analgesic
Intervention Description
The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm
Primary Outcome Measure Information:
Title
Change in arm/hand pain intensity (scale 0-10) during work
Description
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
Time Frame
change from before to after (average of 1,2 and 3 hours after) application of the gel
Secondary Outcome Measure Information:
Title
GROC
Description
Global Rating of Change (GROC) on a scale from - 5(much worsening of pain) to 5(much improvement of pain)
Time Frame
3 hours after application of the gel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars L Andersen, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Research Centre for the Working Environment
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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Acute Effect of Topical Menthol on Carpal Tunnel Syndrome

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