A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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This research study plans to evaluate if multifidus muscle dysfunction is associated with back pain in patients with Multiple Sclerosis (MS).

Detailed Description
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Since the multifidus muscle helps to stabilize the lumbar spine, the investigators hope to learn if there is dysfunction and/or atrophy of this muscle in MS patients who also have back pain. The main objective is to study if it is possible to do a home-exercise program in patients with MS younger then 50 years old and who do not need any assistance to walk. Another objective is to further characterize the multifidus function in those patients. This will be by by measuring the size of muscle at the beginning and end of the study, and also by physical exam. As an exploratory aim, the investigators would like to evaluate the relation between compliance with the home-exercise program and the change in the size of the multifidus muscle and the change in pain.

Official Title
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A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis and Back Pain

Conditions
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Multiple Sclerosis, Back Pain

Intervention / Treatment
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* Other: home - exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed diagnosis by an UAMS neuro-immunologist of relapsing-remitting MS or primary progressive MS or secondary progressive MS Age between 18 years old and 50 years old on consent Complain of low back pain or severe axial back pain English-speaking Exclusion Criteria: Patients that also have the diagnosis of thoracic or lumbar radiculopathy or history of prior thoracic or lumbar spinal surgery. Patients that are currently pregnant EDSS over 5.5 or less than 1.0 Patient younger than 18 years old or older than 50 years old Knee total extension of less than 100 degrees

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Adult patients < 50 years old who have multiple sclerosis and back pain who are undergoing home exercise | Other: home - exercise program<br>* Home exercise program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| study the compliance of a home-exercise program in patients with MS | we will evaluate how many exercise sessions patients do at home versus what was purposed to the patient. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| qualify the multifidus dysfunction in patients with MS - ultrasound | evaluation of the change from baseline of a cross-section area of the multifidus muscle measured by ultrasound | 6 months | 
| qualify the multifidus dysfunction in patients with MS - physical exam | evaluation of the change from baseline of a cross-section area of the multifidus muscle measured by physical exam maneuvers | 6 months | 
| Evaluate the relation between compliance with the home-exercise program and the change in the cross-section area of the multifidus muscle and the change in pain score using PROMIS scale | statistical analysis if compliance with home-exercise affects pain scores and change in area of multifidus muscle | 6 months |