Acute Effect of Topical Menthol on Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

— IRMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716767
• Other study ID #: IRMA07
• Status: Completed
• Phase: N/A
• First received: October 23, 2012
• Last updated: June 27, 2013
• Start date: December 2012
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: National Research Centre for the Working Environment, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 67 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Other:
• Menthol
The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm
• Placebo
The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm

Locations

Country	Name	City	State
Denmark	National Research Centre for the Working Environment	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
National Research Centre for the Working Environment, Denmark	Marquette University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change from before to after (average of 1,2 and 3 hours after) application of the gel	No
Secondary	GROC	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	No