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TerminatedNCT01542827IRMA04Updated Aug 13, 2018

Acute Effect of Topical Menthol on Neck Pain

An interventional study of Biofreeze and Placebo in Musculoskeletal Disorders, sponsored by National Research Centre for the Working Environment, Denmark. Terminated at 1 site in Denmark. Open to participants aged 18 Years to 67 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-13.

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

Why this study was terminated
Lack of resources to perform the study
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 67 Years
Sex
All
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Study summary

Topical menthol gels are classified 'topical analgesics' and are used to relieve aching and tenderness of muscles and joints. 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 neck pain.

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Conditions studied

  • Musculoskeletal Disorders

Keywords

  • neck pain
  • menthol
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In context

Musculoskeletal Diseases

657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.

This study's planned enrollment of 20 is below the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases 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.

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Who can participate

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

Inclusion criteria

  • more than 30 days with neck pain during the last year
  • frequent pain or discomfort, defined as at least 3 days per week
  • pain intensity at least 4 on a scale of 0-10
  • working at least 30 hours per week

Exclusion criteria

Exclusion Criteria:

  • blood pressure above 160/100 mmHg
  • pregnancy
  • life-threatening disease
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Study design

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

Study arms

  • Placebo comparator
    Placebo

    Topical gel containing a menthol scent, but no active menthol

    Other: Placebo

  • Experimental
    Biofreeze

    Biofreeze topical gel containing 3.5% menthol

    Other: Biofreeze

Interventions

  • OtherBiofreeze

    The gel will be applied at 2.5 ml per 500 cm2 to the upper trapezius and neck muscles by a gloved technician

    Also known as: Topical analgesic

  • OtherPlacebo

    The gel will be applied at 2.5 ml per 500 cm2 to the upper trapezius and neck muscles by a gloved technician

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What researchers measure

Primary outcomes

  1. Neck pain intensity (scale 0-10)

    the participant rates pain intensity on a scale from 0-10 immediately before, and 0, 10, 20, 40 and 60 minutes after application of the gel. The primary efficacy endpoint is at 20 min

    Time frame: before and 20 min after application

Secondary outcomes

  1. Pressure pain threshold (PPT)

    pressure pain threshold of the upper trapezius muscle is measured by a handheld algometer immediately before, and 0, 10, 20, 40 and 60 minutes after application of the gel.

    Time frame: before and 20 min after application

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Study locations

1 site
  • National Research Centre for the Working Environment
    Copenhagen, 2100, Denmark
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References and documents

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01542827
Lead sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
Marquette University, Sport and Spine Rehab Clinical Research Foundation
Responsible party
Lars L. Andersen (Principal Investigator, National Research Centre for the Working Environment, Denmark) — Principal investigator
First posted
Mar 2, 2012
Start date
Jan 2016
Primary completion
Jun 2018
Completion
Jun 2018
Last update
Aug 13, 2018

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 terminated, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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