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Acute Effect of Topical Menthol on Carpal Tunnel Syndrome (IRMA)

This study is not yet open for participant recruitment.
Verified December 2012 by National Research Centre for the Working Environment, Denmark
Sponsor:
Collaborator:
Marquette University
Information provided by (Responsible Party):
Lars L. Andersen, National Research Centre for the Working Environment, Denmark
ClinicalTrials.gov Identifier:
NCT01716767
First received: October 23, 2012
Last updated: December 5, 2012
Last verified: December 2012
History of Changes

October 23, 2012
December 5, 2012
December 2012
January 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 in arm/hand pain intensity (scale 0-10) during work [ Time Frame: change from before to 1 hour after application of the gel ] [ Designated as safety issue: No ]
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 1 hour after application of the gel
Complete list of historical versions of study NCT01716767 on ClinicalTrials.gov Archive Site
GROC [ Time Frame: 3 hours after application of the gel ] [ Designated as safety issue: No ]
Global Rating of Change (GROC) on a scale from - 5(much worsening of pain) to 5(much improvement of pain)
Same as current
Not Provided
Not Provided
 
Acute Effect of Topical Menthol on Carpal Tunnel Syndrome
Acute Effect of Topical Menthol on Pain Symptoms in Slaughterhouse Workers With Symptoms of Carpal Tunnel Syndrome: Randomized Controlled Trial

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Carpal Tunnel Syndrome
  • Other: Menthol
    The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm
    Other Name: Topical analgesic
  • Other: Placebo
    The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm
  • Experimental: Menthol
    Biofreeze topical gel containing 3.5% menthol
    Intervention: Other: Menthol
  • Placebo Comparator: Placebo
    Topical gel containing a menthol scent, but no active menthol
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
16
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 67 Years
Yes
Contact: Lars Andersen, PhD 4539165319 lla@nrcwe.dk
Denmark
 
NCT01716767
IRMA07
No
Lars L. Andersen, National Research Centre for the Working Environment, Denmark
National Research Centre for the Working Environment, Denmark
Marquette University
Principal Investigator: Lars L Andersen, PhD Senior Researcher
National Research Centre for the Working Environment, Denmark
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP