CClinicalTrials.gg
CompletedNCT01716767IRMAUpdated Jun 28, 2013

Acute Effect of Topical Menthol on Carpal Tunnel Syndrome

An interventional study of Menthol and Placebo in Carpal Tunnel Syndrome, sponsored by National Research Centre for the Working Environment, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years to 67 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-28.

Sponsored by National Research Centre for the Working Environment, Denmark · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 67 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Carpal Tunnel Syndrome

Keywords

  • Carpal tunnel syndrome
  • hand pain
  • wrist pain
  • arm pain
  • topical menthol
03

In context

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

National Research Centre for the Working Environment, Denmark is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 67 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • pregnancy
  • life-threatening disease
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Menthol

    Biofreeze topical gel containing 3.5% menthol

    Other: Menthol

  • Placebo comparator
    Placebo

    Topical gel containing a menthol scent, but no active menthol

    Other: Placebo

Interventions

  • OtherMenthol

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

    Also known as: Topical analgesic

  • OtherPlacebo

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

06

What researchers measure

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

    Time frame: change from before to after (average of 1,2 and 3 hours after) application of the gel

Secondary outcomes

  1. GROC

    Global Rating of Change (GROC) on a scale from - 5(much worsening of pain) to 5(much improvement of pain)

    Time frame: 3 hours after application of the gel

07

Study locations

1 site
  • National Research Centre for the Working Environment
    Copenhagen, 2100, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01716767
Lead sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
Marquette University
Responsible party
Lars L. Andersen (Principal Investigator, National Research Centre for the Working Environment, Denmark) — Principal investigator
First posted
Oct 30, 2012
Start date
Dec 2012
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Jun 28, 2013

Study contacts

Lars L Andersen, PhD
principal investigator · Professor

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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