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Acute Effect of Topical Menthol on Neck Pain (IRMA04)

Primary Purpose

Musculoskeletal Disorders

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Biofreeze
Placebo
Sponsored by
National Research Centre for the Working Environment, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Disorders focused on measuring neck pain, menthol

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Research Centre for the Working Environment

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Biofreeze

Arm Description

Topical gel containing a menthol scent, but no active menthol

Biofreeze topical gel containing 3.5% menthol

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
February 27, 2012
Last Updated
August 10, 2018
Sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
Marquette University, Sport and Spine Rehab Clinical Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01542827
Brief Title
Acute Effect of Topical Menthol on Neck Pain
Acronym
IRMA04
Official Title
Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of resources to perform the study
Study Start Date
January 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre for the Working Environment, Denmark
Collaborators
Marquette University, Sport and Spine Rehab Clinical Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Disorders
Keywords
neck pain, menthol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Topical gel containing a menthol scent, but no active menthol
Arm Title
Biofreeze
Arm Type
Experimental
Arm Description
Biofreeze topical gel containing 3.5% menthol
Intervention Type
Other
Intervention Name(s)
Biofreeze
Other Intervention Name(s)
Topical analgesic
Intervention Description
The gel will be applied at 2.5 ml per 500 cm2 to the upper trapezius and neck muscles by a gloved technician
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The gel will be applied at 2.5 ml per 500 cm2 to the upper trapezius and neck muscles by a gloved technician
Primary Outcome Measure Information:
Title
Neck pain intensity (scale 0-10)
Description
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 Outcome Measure Information:
Title
Pressure pain threshold (PPT)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars L Andersen, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Research Centre for the Working Environment
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Links:
URL
http://arbejdsmiljoforskning.dk
Description
Company website

Learn more about this trial

Acute Effect of Topical Menthol on Neck Pain

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