Reducing Fatigue in People With Multiple Sclerosis by Treatment With TENS
ConditionMultiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Colorado, Boulder
About this trial
The objective of the randomized, sham-controlled trial will be to evaluate the effectiveness of treatment with transcutaneous electrical nerve stimulation (TENS) at reducing the level of fatigue experienced by people with MS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women18-65 yrs
Able to read, understand, and speak English to ensure safe participation in the project
Clinical diagnosis of relapsing-remitting MS
Self-reported difficulty with walking
Disqualifiers
Vision or hearing problems that have not been corrected
Problems with sensations to temperature, pressure, or pain
Any arm or leg problems that would influence the ability to hold a weight
Surgery to the arms or legs that continues to bother the participant
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous electrical nerve stimulation
DeviceElectrical stimulation applied over selected leg muscle will activate sensory receptors that will transmit signals back into the central nervous system.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Effective doseExperimental treatment 1 intervention
Group B: Sham doseSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fatigue
Questionnaire scores - PROMIS Fatigue (MS) 8a
Time frame
Changes at Weeks 4, 7, and 112
Walking limitations
Questionnaire scores - MS Walking Scale-12
Time frame
Changes at Weeks 4, 7, and 113
Walking endurance
6-min walk test in meters
Time frame
Changes at Weeks 4, 7, and 114
Mobility
Assessment of static and dynamic balance with Mobility Lab, APDM Inc
Time frame
Changes at Weeks 4, 7, and 11Secondary outcomes
1
Quality of life questionnaire
Questionnaire scores
Time frame
Changes at Weeks 4, 7, and 112
Muscle strength
Maximal force in newtons applied by the dorsiflexors and hip flexors of each leg
Time frame
Changes at Weeks 4, 7, and 11Sponsors and contacts
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Source ClinicalTrials.gov