Back to resultsA Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Back Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
home - exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
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
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
Adult patients < 50 years old who have multiple sclerosis and back pain who are undergoing home exercise
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05427045
Brief Title
A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis
Official Title
A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis and Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Incomplete follow up, low enrollment
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 5, 2023 (Actual)
Study Completion Date
May 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Adult patients < 50 years old who have multiple sclerosis and back pain who are undergoing home exercise
Intervention Type
Other
Intervention Name(s)
home - exercise program
Intervention Description
Home exercise program
Primary Outcome Measure Information:
Title
study the compliance of a home-exercise program in patients with MS
Description
we will evaluate how many exercise sessions patients do at home versus what was purposed to the patient.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
qualify the multifidus dysfunction in patients with MS - ultrasound
Description
evaluation of the change from baseline of a cross-section area of the multifidus muscle measured by ultrasound
Time Frame
6 months
Title
qualify the multifidus dysfunction in patients with MS - physical exam
Description
evaluation of the change from baseline of a cross-section area of the multifidus muscle measured by physical exam maneuvers
Time Frame
6 months
Title
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
Description
statistical analysis if compliance with home-exercise affects pain scores and change in area of multifidus muscle
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika Santos Horta, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis
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