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

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

Sponsors

Lead Sponsor: University of Arkansas

Source University of Arkansas
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.

Overall Status Recruiting
Start Date 2022-05-01
Completion Date 2024-05-01
Primary Completion Date 2023-05-01
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
study the compliance of a home-exercise program in patients with MS 6 months
Secondary Outcome
Measure Time Frame
qualify the multifidus dysfunction in patients with MS - ultrasound 6 months
qualify the multifidus dysfunction in patients with MS - physical exam 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 6 months
Enrollment 10
Condition
Intervention

Intervention Type: Other

Intervention Name: home - exercise program

Description: Home exercise program

Arm Group Label: Intervention group

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

50 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Erika Santos Horta, MD Principal Investigator University of Arkansas
Overall Contact

Last Name: Erika Santos Horta, MD

Phone: (501) 686-5135

Email: [email protected]

Location
Facility: Status: Contact: University of Arkansas for Medical Sciences Erika Santos Horta, MD [email protected]
Location Countries

United States

Verification Date

2022-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Intervention group

Type: Experimental

Description: Adult patients < 50 years old who have multiple sclerosis and back pain who are undergoing home exercise

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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