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Completed

NCT Number: NCT01716767

Acute Effect of Topical Menthol on Carpal Tunnel Syndrome

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.

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Key information

Conditions

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

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Research Centre for the Working Environment

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Menthol

Other

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

Other names: Topical analgesic

Placebo

Other

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

Primary outcomes

  1. Change in arm/hand pain intensity (scale 0-10) during work

    Time frame: 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 outcomes

  1. GROC

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

National Research Centre for the Working Environment, Denmark

Other Gov

Collaborators

  • Marquette University

Registry information

Official study title

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

Acronym: IRMA

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 30, 2012
Registry last updated
Jun 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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