Trial of Mannitol Cream for Pain Relief After a Long Run

Pain Clinical Trial

— PainCream  

Official title:

Randomized Trial of Mannitol Cream for Pain Relief After a Long Run

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843088
• Other study ID #: H13-00106
• Status: Completed
• Phase: Phase 1
• First received: April 16, 2013
• Last updated: October 10, 2013
• Start date: May 2013
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 74 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• no major skin allergies

• no allergy to mannitol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Mannitol 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 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.

Locations

Country	Name	City	State
Canada	Dr. Helene Bertrand, University of British Columbia, Department of Family Practice	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	For six days following run	No
Secondary	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.	For six days, starting on day of race.	Yes