Acute Effect of Topical Menthol on Neck Pain

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01542827

Acronym

IRMA04

Enrollment

Registered

2012-03-02

Start date

2016-01-31

Completion date

2018-06-30

Last updated

2018-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Disorders

Keywords

neck pain, menthol

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.

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

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 67 Years

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

* blood pressure above 160/100 mmHg * pregnancy * life-threatening disease

Design outcomes

Primary

Measure	Time frame	Description
Neck pain intensity (scale 0-10)	before and 20 min after application	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

Measure	Time frame	Description
Pressure pain threshold (PPT)	before and 20 min after application	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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026