PainPhase 1PainCreamNCT01843088
Trial of Mannitol Cream for Pain Relief After a Long Run
A Phase 1 study testing Mannitol cream in people with Pain, run by University of British Columbia at 1 site in Canada.
Trial summary
Mannitol cream has been shown clinically to be effective for pain control. To determine if this effect is worth testing on a larger scale, 170 runners will receive a sample of 25% mannitol cream to apply on one leg, and the cream base without the mannitol on the other leg following a 10 km or longer run, and for the… Read more about this study
- Who is it for?
- Ages 19 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Mannitol cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Jul 2013
- Phase
- Phase 1
- 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 19 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- either:
- never ran 10 km or more, or;
- NRS pain level greater than 5/10 in both legs following a 10 km or more run
Who cannot join
- no major skin allergies
- no allergy to mannitol
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dr. Helene Bertrand, University of British Columbia, Department of Family Practice
Vancouver, British Columbia, V7M 2K2
About this study
Official title: Randomized Trial of Mannitol Cream for Pain Relief After a Long Run
Mannitol cream has been shown clinically to be effective for pain control. To determine if this effect is worth testing on a larger scale, 170 runners will receive a sample of 25% mannitol cream to apply on one leg, and the cream base without the mannitol on the other leg following a 10 km or longer run, and for the following five days. Mannitol and control legs will be chosen at random for each runner. Pain scores before and after cream application will be acquired each day for each leg. Means and standard deviations found will be used to determine the size of a larger study.
Read the detailed description
The hypothesis for this study is that Mannitol cream will reduce post long run pain more than vehicle cream alone. In this parallel design, 170 runners who usually experience a pain level greater than 5/10 on a numerical rating scale from 0 to 10 where zero is no pain and 10 is the worst pain ever, will be given a cream containing 25% mannitol to apply on one leg and the vehicle cream to apply on the other leg. The cream assignment will be randomized, and the runner, the person supplying the cream and the person inputting the data will be blinded as to which leg received which cream. Pain levels in each leg following the long run will be recorded, via an e-mail questionnaire, or, failing this, by telephone, the day of the run, and each day, for five days following the run. Mean and standard deviations for pain levels will be calculated for each treatment leg, and a repeated measures ANOVA (Analysis Of VAriance) will be done comparing the pain levels in each leg over the six days. Using this information, if the NRS (Numeric rating scale) pain levels differ by more than 1/10 between the two groups, a larger study will be conducted using the information gathered in this study to determine sample size.
- Conditions
- Pain
- Being tested
- Mannitol cream, Placebo Cream
- Keywords
- Pain, exercise, muscle
- Medical subject headings
- Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mannitol creamDrug
Also called Mannitol, PENcream, Commercially available proprietary cream.
25% mannitol in PENcream (See above) (See above) This will be applied as needed to one side of the body (blinded assignment) over painful painful areas of legs following a 10 km run, on the day of the run and for five days afterwards.
Placebo CreamDrug
Also called PENcream, commercially available proprietary cream.
This is the vehicle only cream (PENcream) (See above) This will be applied as needed to one side of the body (blinded assignment) over painful painful areas of legs following a 10 km run, on the day of the run and for five days afterwards.
| Study group | Role | What they receive |
|---|---|---|
| Mannitol cream | Experimental | cream containing 25% mannitol, applied as often and as much as needed to one leg ( chosen at random), on the day of a 10 km run, following the run and for five days afterwards Receives: Drug: Mannitol cream |
| Placebo cream | Placebo comparator | Same carrier cream as that containing the active ingredient, mannitol, but without the active ingredient. Placebo cream to be applied to the painful areas of the other leg, chosen at random, on the day of a 10 km or more race, following the race, and as needed for the five days after the race. It is to be noted that, as almost no mannitol is absorbed through the skin, it is highly unlikely that this would involve the pain levels in the placebo leg. Receives: Drug: Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NRS (Numeric rating scale) pain score
NRS (Numeric rating scale) pain score from zero, no pain, to 10 worst pain ever. Change in pain score will be measured daily starting on day of race, comparing pain following the race, prior to the first cream application, to the daily scores for the subsequent five days. Pain levels in leg given mannitol cream, and leg given placebo cream will be compared according to the change in their pain scores.
Measured: For six days following run
Secondary outcomes (1)
side effects of cream
Description of side effects by subjects. The only likely to side effect would be a contact dermatitis as percutaneous systemic absorption of mannitol is negligible. We will therefore monitor for contact dermatitis, and record its incidence, should it happen in this small sample. In our experience with over 400 recipients, there have been no cases of contact dermatitis.
Measured: For six days, starting on day of race.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene Bertrand, MD, CCFP, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843088
- Sponsor's protocol ID
- H13-00106
- Acronym
- PainCream
- Status last verified
- Oct 2013
- First submitted
- 16 Apr 2013
- Last updated
- 11 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cavone L, Calosi L, Cinci L, Moroni F, Chiarugi A. Topical mannitol reduces inflammatory edema in a rat model of arthritis. Pharmacology. 2012;89(1-2):18-21. doi: 10.1159/000335094. Epub 2012 Jan 10.
PubMed 22236612
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Mannitol Cream for Pain Relief After a Long Run
- ClinicalTrials.gov ID
- NCT01843088
- Acronym / sponsor ID
- PainCream / H13-00106
- Conditions
- Pain
- Keywords
- Pain, exercise, muscle
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Apr 2013 (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.
Mannitol cream has been shown clinically to be effective for pain control. To determine if this effect is worth testing on a larger scale, 170 runners will receive a sample of 25% mannitol cream to apply on one leg, and the cream base without the mannitol on the other leg following a 10 km or longer run, and for the following five days. Mannitol and control legs will be chosen at random for each runner. Pain scores before and after cream application will be acquired each day for each leg. Means and standard deviations found will be used to determine the size of a larger study.
Detailed description
The hypothesis for this study is that Mannitol cream will reduce post long run pain more than vehicle cream alone. In this parallel design, 170 runners who usually experience a pain level greater than 5/10 on a numerical rating scale from 0 to 10 where zero is no pain and 10 is the worst pain ever, will be given a cream containing 25% mannitol to apply on one leg and the vehicle cream to apply on the other leg. The cream assignment will be randomized, and the runner, the person supplying the cream and the person inputting the data will be blinded as to which leg received which cream. Pain levels in each leg following the long run will be recorded, via an e-mail questionnaire, or, failing this, by telephone, the day of the run, and each day, for five days following the run. Mean and standard deviations for pain levels will be calculated for each treatment leg, and a repeated measures ANOVA (Analysis Of VAriance) will be done comparing the pain levels in each leg over the six days. Using this information, if the NRS (Numeric rating scale) pain levels differ by more than 1/10 between the two groups, a larger study will be conducted using the information gathered in this study to determine sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mannitol cream | Experimental | Drug: Mannitol creamcream containing 25% mannitol, applied as often and as much as needed to one leg ( chosen at random), on the day of a 10 km run, following the run and for five days afterwards |
| Placebo cream | Placebo comparator | Drug: Placebo CreamSame carrier cream as that containing the active ingredient, mannitol, but without the active ingredient. Placebo cream to be applied to the painful areas of the other leg, chosen at random, on the day of a 10 km or more race, following the race, and as needed for the five days after the race. It is to be noted that, as almost no mannitol is absorbed through the skin, it is highly unlikely that this would involve the pain levels in the placebo leg. |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- never ran 10 km or more, or;
- NRS pain level greater than 5/10 in both legs following a 10 km or more run
Key exclusion criteria (2 listed)
- no major skin allergies
- no allergy to mannitol
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 |
|---|---|---|
| Mannitol creamAlso: Mannitol, PENcream, Commercially available proprietary cream.25% mannitol in PENcream (See above) (See above) This will be applied as needed to one side of the body (blinded assignment) over painful painful areas of legs following a 10 km run, on the day of the run and for five days afterwards. | Drug | Mannitol cream |
| Placebo CreamAlso: PENcream, commercially available proprietary cream.This is the vehicle only cream (PENcream) (See above) This will be applied as needed to one side of the body (blinded assignment) over painful painful areas of legs following a 10 km run, on the day of the run and for five days afterwards. | Drug | Placebo cream |
Primary outcome
Change in NRS (Numeric rating scale) pain score
Time frame: For six days following run
NRS (Numeric rating scale) pain score from zero, no pain, to 10 worst pain ever. Change in pain score will be measured daily starting on day of race, comparing pain following the race, prior to the first cream application, to the daily scores for the subsequent five days. Pain levels in leg given mannitol cream, and leg given placebo cream will be compared according to the change in their pain scores.
1 secondary outcome
side effects of cream
Time frame: For six days, starting on day of race.
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 11 Oct 2013.
- Results publication: PubMed 22236612Cavone L, Calosi L, Cinci L, Moroni F, Chiarugi A. Topical mannitol reduces inflammatory edema in a rat model of arthritis. Pharmacology. 2012;89(1-2):18-21. doi: 10.1159/000335094. Epub 2012 Jan 10.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Helene Bertrand, MD, CCFP principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mannitol cream in people with Pain, run by University of British Columbia at 1 site in Canada.
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 3 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 11 Oct 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NRS (Numeric rating scale) pain score (time frame: For six days following run). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01843088, which also lists 1 linked publication.
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 11 Oct 2013.