Carpal Tunnel SyndromeIRMANCT01716767
Acute Effect of Topical Menthol on Carpal Tunnel Syndrome
A study testing Menthol in people with Carpal Tunnel Syndrome, 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 pain of the musculoskeletal system. 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
- Carpal Tunnel Syndrome
- What is being tested?
- Menthol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2012to Jan 2013
- 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
- positive Phalen test
- positive Tinel test
- nocturnal hand/wrist pain
- pain intensity of at least 4 in the hand/wrist
- the pain should have lasted at least 3 months
Who cannot join
- 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: Acute Effect of Topical Menthol on Pain Symptoms in Slaughterhouse Workers With Symptoms of Carpal Tunnel Syndrome: Randomized Controlled Trial
Topical menthol gels are classified 'topical analgesics' and are used to relieve pain of the musculoskeletal system. 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 pain symptoms in slaughterhouse workers with symptoms of Carpal Tunnel Syndrome.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Menthol, Placebo
- Keywords
- Carpal tunnel syndrome, hand pain, wrist pain, arm pain, topical menthol
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MentholOther
Also called Topical analgesic
The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm
PlaceboOther
The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm
| Study group | Role | What they receive |
|---|---|---|
| Menthol | Experimental | Biofreeze topical gel containing 3.5% menthol Receives: Other: Menthol |
| Placebo | Placebo comparator | Topical gel containing a menthol scent, but no active menthol Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arm/hand pain intensity (scale 0-10) during work
the participant rates "pain intensity during the last hour" on a scale from 0-10 immediately before, and 1,2,3 hours after application of the gel. The primary outcome is the change from before to after (average of 1,2 and 3 hours after) application of the gel
Measured: change from before to after (average of 1,2 and 3 hours after) application of the gel
Secondary outcomes (1)
GROC
Global Rating of Change (GROC) on a scale from - 5(much worsening of pain) to 5(much improvement of pain)
Measured: 3 hours after application of the gel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre for the Working Environment, Denmark
- Sponsor type
- Other government
- Collaborators
- Marquette University
- 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
- NCT01716767
- Sponsor's protocol ID
- IRMA07
- Acronym
- IRMA
- Status last verified
- Jun 2013
- First submitted
- 23 Oct 2012
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Topical Menthol on Pain Symptoms in Slaughterhouse Workers With Symptoms of Carpal Tunnel Syndrome: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01716767
- Acronym / sponsor ID
- IRMA / IRMA07
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal tunnel syndrome, hand pain, wrist pain, arm pain, topical menthol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Research Centre for the Working Environment, DenmarkOther government
- Collaborators
- Marquette University
- Study start
- Dec 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Oct 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 pain of the musculoskeletal system. 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 pain symptoms in slaughterhouse workers with symptoms of Carpal Tunnel Syndrome.
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 |
|---|---|---|
| Menthol | Experimental | Other: MentholBiofreeze topical gel containing 3.5% menthol |
| Placebo | Placebo comparator | Other: PlaceboTopical gel containing a menthol scent, but no active menthol |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- positive Phalen test
- positive Tinel test
- nocturnal hand/wrist pain
- pain intensity of at least 4 in the hand/wrist
- the pain should have lasted at least 3 months
Key exclusion criteria (2 listed)
- 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 |
|---|---|---|
| MentholAlso: Topical analgesicThe gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm | Other | Menthol |
| PlaceboThe gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm | Other | Placebo |
Primary outcome
Change in arm/hand pain intensity (scale 0-10) during work
Time frame: change from before to after (average of 1,2 and 3 hours after) application of the gel
the participant rates "pain intensity during the last hour" on a scale from 0-10 immediately before, and 1,2,3 hours after application of the gel. The primary outcome is the change from before to after (average of 1,2 and 3 hours after) application of the gel
1 secondary outcome
GROC
Time frame: 3 hours after application of the gel
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
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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 Menthol in people with Carpal Tunnel Syndrome, 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 28 Jun 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in arm/hand pain intensity (scale 0-10) during work (time frame: change from before to after (average of 1,2 and 3 hours after) application of the gel). 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 28 Jun 2013.