Effect of Acetominophen an Gait Fatigue in Multiple Sclerosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorHunter College of City University of New York

About this trial

The goal of this observational study is to compare the impact of an antipyretic, acetaminophen to a placebo on gait fatigue in persons with multiple sclerosis (MS). The primary question this study is asking is the following: will the antipyretic effects of acetaminophen result in less gait fatigue in persons with MS? Participants will be asked to come for two sessions over a 1 week period. In the first week, subjects will be blind-randomized into either the acetaminophen or placebo group. They will then undergo a test to determine their gait speed by performing two 25 foot walks at their best comfortable pace. The walks will be 1 minute apart. The average speed from those 2 walks will be obtained. Subjects will then take either the acetaminophen or the placebo. Following a 45 minute rest period they will then get on a treadmill and will walk at the previously determined speed for as long as they can. Walking will stop if the subject can no longer maintain the speed or if they wish to no longer continue. The subjects will wear a safety harness at all times during the walk to prevent falls. Heart rate and core body temperature will be measured via skin sensors. One week later the subjects will return and repeat the procedure but this time in the opposite condition. Subjects who took the acetaminophen will take the placebo and subjects who took the placebo will take the acetaminophen. The difference between distance walked in the 2 conditions will be compared.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A definitive MS diagnosis confirmed by self-report,

The ability to walk for 2 minutes continuously with or without assistive device ---Age 18-65

Provide a blood test within the last 6 months to 1 year reflecting normal liver and renal profile (normal liver enzymes and normal creatinine level).

Disqualifiers

Any current or recent exacerbations

Any adverse reaction to antipyretics

Recent use of steroids

Any non-MS conditions that interfere with walking performance.

Trial population

ambulatory persons with MS

Trial design

Design model

Case-crossover

Time perspective

Retrospective

Treatments tested in this trial

  • 1000mg acetaminophen or placebo

    Drug

    Acetaminophen or placebo

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Persons with Multiple Sclerosis1 intervention

Trial outcomes

Primary outcomes

1

Treadmill walk time to fatigue

Time frame
From enrollment to end of treatment at 1 week
2

Treadmill time to fatigue

Participants will walk on a treadmill until either they wish to stop, or, if they are unable to maintain a specific speed. Treadmill speed will be based on the speed they achieve during a 25 foot walk test where they would be asked to walk at their best comfortable speed over the distance of 25 feet. Subjects will receive either acetaminophen or placebo before the treadmill walk . One minute after the first treadmill walk the subjects will return and repeat the walk , this time taking whichever pill they dod not take the first time (acetaminophen or placebo)

Time frame
from enrollment to end of data collection for each participant will be one week

Secondary outcomes

Other outcomes

Sponsors and contacts

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