Acute Effect of Topical Menthol on Carpal Tunnel Syndrome

NCT01716767 | Completed

• 1 other identifier: IRMA07
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal tunnel syndrome; hand pain; wrist pain; arm pain; topical menthol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• GROC

  3 hours after application of the gel

Study Arms (2)

Menthol

EXPERIMENTAL

Biofreeze topical gel containing 3.5% menthol

Other: Menthol

Placebo

PLACEBO COMPARATOR

Topical gel containing a menthol scent, but no active menthol

Other: Placebo

Interventions

Menthol OTHER

The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm

Also known as: Topical analgesic

Menthol

Placebo OTHER

The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm

Placebo

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnancy
• life-threatening disease

Sponsors & Collaborators

• National Research Centre for the Working Environment, Denmark: lead
• Marquette University: collaborator

Study Sites (1)

National Research Centre for the Working Environment

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Menthol; Analgesics

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Lars L Andersen, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: October 30, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

DK (1)