Acute Effect of Topical Menthol on Neck Pain

Musculoskeletal Disorders Clinical Trial

— IRMA04  

Official title:

Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01542827
• Other study ID #: IRMA04
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: June 2018

Study information

• Verified date: August 2018
• Source: National Research Centre for the Working Environment, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Musculoskeletal Disorders

Intervention

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

Locations

Country	Name	City	State
Denmark	National Research Centre for the Working Environment	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
National Research Centre for the Working Environment, Denmark	Marquette University, Sport and Spine Rehab Clinical Research Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	before and 20 min after application
Secondary	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.	before and 20 min after application

External Links

•   Company website