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

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

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis; Back Pain
• Intervention / Treatment: Other: home - exercise program

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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
Correlation Between Compliance and Plain and Size of Muscle	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	6 months

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Erika Santos Horta, MD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Back Pain; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 263068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No