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Completed

NCT Number: NCT01843088

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.

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Key information

Conditions

Pain Behavior Motor Activity Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dr. Helene Bertrand, University of British Columbia, Department of Family Practice

Vancouver, British Columbia, V7M 2K2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mannitol cream

Drug

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.

Other names: Mannitol, PENcream, Commercially available proprietary cream.

placebo cream

Drug

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.

Other names: PENcream, commercially available proprietary cream.

Primary outcomes

  1. 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.

Secondary outcomes

  1. side effects of cream

    Time frame: For six days, starting on day of race.

    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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Acronym: PainCream

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 30, 2013
Registry last updated
Oct 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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