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Acute Effect of Topical Menthol on Carpal Tunnel Syndrome

NCT ID: NCT01716767

Last Updated: 2013-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Carpal Tunnel Syndrome

Keywords

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Carpal tunnel syndrome hand pain wrist pain arm pain topical menthol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Menthol

Biofreeze topical gel containing 3.5% menthol

Group Type EXPERIMENTAL

Menthol

Intervention Type OTHER

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

Placebo

Topical gel containing a menthol scent, but no active menthol

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Menthol

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

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Topical analgesic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marquette University

OTHER

Sponsor Role collaborator

National Research Centre for the Working Environment, Denmark

OTHER_GOV

Sponsor Role lead

Responsible Party

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Lars L. Andersen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars L Andersen, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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National Research Centre for the Working Environment

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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IRMA07

Identifier Type: -

Identifier Source: org_study_id