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

Not Applicable

Terminated

• Conditions: Multiple Sclerosis; Back Pain
• Interventions: Other: home - exercise program

• Registration Number: NCT05427045
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Primary Completion: 2023-05-05
• Study Completion: 2023-05-05
• Status Verified: 2024-02
• Results First Submitted: 2024-02-08
• Results First Submitted QC: 2024-11-05
• Last Update Submitted: 2024-11-05
• Results First Posted: 2024-11-07
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	home - exercise program	Adult patients \< 50 years old who have multiple sclerosis and back pain who are undergoing home exercise

Primary Outcome Measures

Name	Time	Method
Study the Compliance of a Home-exercise Program in Patients With MS	6 months	we will evaluate how many exercise sessions patients do at home versus what was purposed to the patient.

Secondary Outcome Measures

Name	Time	Method
Qualify the Multifidus Dysfunction in Patients With MS - Ultrasound	6 months	evaluation of the change from baseline of a cross-section area of the multifidus muscle measured by ultrasound
Qualify the Multifidus Dysfunction in Patients With MS - Physical Exam	6 months	evaluation of the change from baseline of a cross-section area of the multifidus muscle measured by physical exam maneuvers
Correlation Between Compliance and Plain and Size of Muscle	6 months	statistical analysis will be done to verify 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

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States