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Clinical Trials/NCT05427045
NCT05427045
Terminated
Not Applicable

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

University of Arkansas1 site in 1 country7 target enrollmentMay 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Arkansas
Enrollment
7
Locations
1
Primary Endpoint
Study the Compliance of a Home-exercise Program in Patients With MS
Status
Terminated
Last Updated
last year

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
May 5, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Study the Compliance of a Home-exercise Program in Patients With MS

Time Frame: 6 months

we will evaluate how many exercise sessions patients do at home versus what was purposed to the patient.

Secondary Outcomes

  • Qualify the Multifidus Dysfunction in Patients With MS - Ultrasound(6 months)
  • Qualify the Multifidus Dysfunction in Patients With MS - Physical Exam(6 months)
  • Correlation Between Compliance and Plain and Size of Muscle(6 months)

Study Sites (1)

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