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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05427045
• Other study ID #: 263068
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 5, 2023

Study information

• Verified date: May 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 5, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• home - exercise program
Home exercise program

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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