Acute Effect of Topical Menthol on Neck Pain

NCT01542827 | Terminated

• 1 other identifier: IRMA04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Disorders

Keywords

neck pain; menthol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pressure pain threshold (PPT)

  before and 20 min after application

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Topical gel containing a menthol scent, but no active menthol

Other: Placebo

Biofreeze

EXPERIMENTAL

Biofreeze topical gel containing 3.5% menthol

Other: Biofreeze

Interventions

Biofreeze OTHER

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

Also known as: Topical analgesic

Biofreeze

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Research Centre for the Working Environment, Denmark: lead
• Marquette University: collaborator
• Sport and Spine Rehab Clinical Research Foundation: collaborator

Study Sites (1)

National Research Centre for the Working Environment

Copenhagen, 2100, Denmark

Location

Related Links

• Company website

MeSH Terms

Conditions

Musculoskeletal Diseases; Neck Pain

Interventions

Analgesics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Lars L Andersen, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 2, 2012
• Study Start: January 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

DK (1)