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Clinical Trial: Impact of cold compression on fatigue, pain and functional performance in MS

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Details
Type of MS: RRMS|SPMS
Treatment mode of action: To affect fatigue, pain and functional performance
Number of Subjects: 60
Medication: cooling device
Location: Kentucky
Institutions: Bellarmine University Physical Therapy Program
2001 Newburg Road,
Louisville, KY 40205  Contact Information
Laura Miller, PT, EdD
502-272-7915
lmiller2@bellarmine.edu

Funding:

n/a

Description

Heat sensitivity is a common negative condition in people with Multiple Sclerosis and physical fatigue is one of the most frequently reported symptoms that can affect quality of life. Increases in body temperature may make fatigue and heat-related symptoms worse. Decreasing body temperature via cooling devices may decrease these symptoms and improve physical abilities and quality of life. The purpose of this study is to investigate the beneficial effects of acute bilateral lower extremity cooling on fatigue, pain and functional performance including endurance, balance, and strength in individuals with mild to moderate sign/ symptoms of MS.

Procedures
In this study, you will be asked to use the Aquilo cold-compression Pants for 15 minutes circulating either cold water or tap water.  One treatment condition on either of 2 separate sessions a week apart for about an hour. The following outcome measures will be evaluated before and after the use of the 15-minute session: heart rate, blood pressure, pulse oximetry, skin temperature, pain algometry (pain pressure threshold). 

Functional performance measure will include: 2-minute walk test (2MWT), Gait Speed (10-meter walk test), Timed Up and Go (TUG) w/cognitive challenge, Hand grip strength and measures of leg strength.  
You will also self-rate your pain levels on a scale from 0-10 before the therapy, 5  and 10 minutes into the therapy, at the end of therapy just after pants are removed. 

Just prior to and immediately after the cold compression session with the assistance of a study researcher you will be asked to complete a fatigue (modified Fatigue Impact Scale, MFIS) and 2 pain questionnaires (Brief Pain Inventory (BPI)  and Douleur Neuropathique 4 Questions (DN4)). 

You will also be asked to complete 48 hours after treatment the  Modified Fatigue Impact Scale (mFIS) and Brief Pain Inventory (BPI). Your participation in this study will last for 9 days.

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