Musculoskeletal DisordersIRMA04NCT01542827
Acute Effect of Topical Menthol on Neck Pain
A study testing Biofreeze in people with Musculoskeletal Disorders, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Disorders
- What is being tested?
- Biofreeze
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- blood pressure above 160/100 mmHg
- pregnancy
- life-threatening disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National Research Centre for the Working Environment
Copenhagen, 2100
About this study
Official title: Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace
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
- Being tested
- Biofreeze, Placebo
- Keywords
- neck pain, menthol
- Medical subject headings
- Musculoskeletal Diseases, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofreezeOther
Also called Topical analgesic
The gel will be applied at 2.5 ml per 500 cm2 to the upper trapezius and neck muscles by a gloved technician
PlaceboOther
The gel will be applied at 2.5 ml per 500 cm2 to the upper trapezius and neck muscles by a gloved technician
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Topical gel containing a menthol scent, but no active menthol Receives: Other: Placebo |
| Biofreeze | Experimental | Biofreeze topical gel containing 3.5% menthol Receives: Other: Biofreeze |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before and 20 min after application
Secondary outcomes (1)
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.
Measured: before and 20 min after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startJan 2016
- Primary completionJun 2018
- Study completionJun 2018
Why it stopped: Lack of resources to perform the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- Collaborators
- Marquette University, Sport and Spine Rehab Clinical Research Foundation
- Responsible party
- Principal investigator, Lars L. Andersen, National Research Centre for the Working Environment, Denmark
- Investigators
- Lars L Andersen, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542827
- Sponsor's protocol ID
- IRMA04
- Acronym
- IRMA04
- Status last verified
- Aug 2018
- First submitted
- 27 Feb 2012
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish: Integreret Motion på Arbejdspladsen (IRMA) English: Implementation of Exercise at the Workplace
- ClinicalTrials.gov ID
- NCT01542827
- Acronym / sponsor ID
- IRMA04 / IRMA04
- Conditions
- Musculoskeletal Disorders
- Keywords
- neck pain, menthol
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of resources to perform the study
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Collaborators
- Marquette University, Sport and Spine Rehab Clinical Research Foundation
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboTopical gel containing a menthol scent, but no active menthol |
| Biofreeze | Experimental | Other: BiofreezeBiofreeze topical gel containing 3.5% menthol |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- blood pressure above 160/100 mmHg
- pregnancy
- life-threatening disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiofreezeAlso: Topical analgesicThe gel will be applied at 2.5 ml per 500 cm2 to the upper trapezius and neck muscles by a gloved technician | Other | Biofreeze |
| PlaceboThe gel will be applied at 2.5 ml per 500 cm2 to the upper trapezius and neck muscles by a gloved technician | Other | Placebo |
Primary outcome
Neck pain intensity (scale 0-10)
Time frame: 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
1 secondary outcome
Pressure pain threshold (PPT)
Time frame: before and 20 min after application
Results and safety
The study was stopped early (reason given: Lack of resources to perform the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Company websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars L Andersen, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofreeze in people with Musculoskeletal Disorders, run by National Research Centre for the Working Environment, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of resources to perform the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain intensity (scale 0-10) (time frame: before and 20 min after application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.