Acute Effect of Topical Menthol on Neck Pain (IRMA04)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by National Research Centre for the Working Environment, Denmark
Sponsor:
Collaborators:
Marquette University
Sport and Spine Rehab Clinical Research Foundation
Information provided by (Responsible Party):
Lars L. Andersen, National Research Centre for the Working Environment, Denmark
ClinicalTrials.gov Identifier:
NCT01542827
First received: February 27, 2012
Last updated: September 29, 2014
Last verified: September 2014

February 27, 2012
September 29, 2014
January 2015
June 2015   (final data collection date for primary outcome measure)
Neck pain intensity (scale 0-10) [ Time Frame: before and 20 min after application ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01542827 on ClinicalTrials.gov Archive Site
Pressure pain threshold (PPT) [ Time Frame: before and 20 min after application ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Acute Effect of Topical Menthol on Neck Pain
Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace

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.

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
Musculoskeletal Disorders
  • Other: Biofreeze
    The gel will be applied at 2.5 ml per 500 cm2 to the upper trapezius and neck muscles by a gloved technician
    Other Name: Topical analgesic
  • Other: Placebo
    The gel will be applied at 2.5 ml per 500 cm2 to the upper trapezius and neck muscles by a gloved technician
  • Placebo Comparator: Placebo
    Topical gel containing a menthol scent, but no active menthol
    Intervention: Other: Placebo
  • Experimental: Biofreeze
    Biofreeze topical gel containing 3.5% menthol
    Intervention: Other: Biofreeze
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
20
June 2015
June 2015   (final data collection date for primary outcome measure)

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:

  • blood pressure above 160/100 mmHg
  • pregnancy
  • life-threatening disease
Both
18 Years to 67 Years
Yes
Contact: Lars Andersen, PhD 4539165319 lla@nrcwe.dk
Denmark
 
NCT01542827
IRMA04
No
Lars L. Andersen, National Research Centre for the Working Environment, Denmark
National Research Centre for the Working Environment, Denmark
  • Marquette University
  • Sport and Spine Rehab Clinical Research Foundation
Principal Investigator: Lars L Andersen, PhD Professor
National Research Centre for the Working Environment, Denmark
September 2014

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