Acute Effect of Topical Menthol on Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Other: Placebo; Other: Menthol

• Registration Number: NCT01716767
• Lead Sponsor: National Research Centre for the Working Environment, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-30
• Study Start: 2012-12
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-27
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Topical gel containing a menthol scent, but no active menthol
Menthol	Menthol	Biofreeze topical gel containing 3.5% menthol

Primary Outcome Measures

Name	Time	Method
Change in arm/hand pain intensity (scale 0-10) during work	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

Secondary Outcome Measures

Name	Time	Method
GROC	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)

Trial Locations

Locations (1)

National Research Centre for the Working Environment; 🇩🇰 Copenhagen, Denmark