Acute Effect of Topical Menthol on Neck Pain (IRMA04)

This study is not yet open for participant recruitment.
Verified June 2013 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: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Musculoskeletal Disorders
Other: Biofreeze
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace

Resource links provided by NLM:


Further study details as provided by National Research Centre for the Working Environment, Denmark:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Topical gel containing a menthol scent, but no active menthol
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
Experimental: Biofreeze
Biofreeze topical gel containing 3.5% menthol
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

  Eligibility

Ages Eligible for Study:   18 Years to 67 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542827

Contacts
Contact: Lars Andersen, PhD 4539165319 lla@nrcwe.dk

Locations
Denmark
National Research Centre for the Working Environment Not yet recruiting
Copenhagen, Denmark, 2100
Contact: Lars L Andersen, PhD    39165319 ext 0045    lla@nrcwe.dk   
Sponsors and Collaborators
National Research Centre for the Working Environment, Denmark
Marquette University
Sport and Spine Rehab Clinical Research Foundation
Investigators
Principal Investigator: Lars L Andersen, PhD Professor
  More Information

Additional Information:
No publications provided

Responsible Party: Lars L. Andersen, Principal Investigator, National Research Centre for the Working Environment, Denmark
ClinicalTrials.gov Identifier: NCT01542827     History of Changes
Other Study ID Numbers: IRMA04
Study First Received: February 27, 2012
Last Updated: June 27, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by National Research Centre for the Working Environment, Denmark:
neck pain
menthol

Additional relevant MeSH terms:
Musculoskeletal Diseases
Menthol
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014