Acute Effect of Topical Menthol on Neck Pain

NCT ID: NCT01542827

Last Updated: 2018-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Musculoskeletal Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Topical gel containing a menthol scent, but no active menthol

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Biofreeze

Biofreeze topical gel containing 3.5% menthol

Group Type EXPERIMENTAL

Biofreeze

Intervention Type OTHER

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

Interventions

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Biofreeze

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

Placebo

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

Other Intervention Names

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Topical analgesic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marquette University

OTHER

Sponsor Role collaborator

Sport and Spine Rehab Clinical Research Foundation

OTHER

Sponsor Role collaborator

National Research Centre for the Working Environment, Denmark

OTHER_GOV

Sponsor Role lead

Responsible Party

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Lars L. Andersen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars L Andersen, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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National Research Centre for the Working Environment

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Related Links

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Other Identifiers

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IRMA04

Identifier Type: -

Identifier Source: org_study_id

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