Clinical trial NCT01843088: Trial of Mannitol Cream for Pain Relief After a Long Run
Official title: Randomized Trial of Mannitol Cream for Pain Relief After a Long Run
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: Pain
exercise
muscle
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 170
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in NRS (Numeric rating scale) pain score
timeFrame: For six days following run
Secondary outcomes:
measure: side effects of cream
timeFrame: For six days, starting on day of race.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Dr. Helene Bertrand, University of British Columbia, Department of Family Practice
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Helene Bertrand, MD, CCFP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.