An interventional study of home - exercise program in Multiple Sclerosis and Back Pain, sponsored by University of Arkansas. Terminated at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by University of Arkansas · Not applicable, Interventional, and Treatment
This research study plans to evaluate if multifidus muscle dysfunction is associated with back pain in patients with Multiple Sclerosis (MS).
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.
3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.
This study's enrollment of 7 is below the median of 50 across 2,386 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Arkansas is the lead sponsor of 398 studies on the registry; 37 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
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Exclusion Criteria:
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
Adult patients \< 50 years old who have multiple sclerosis and back pain who are undergoing home exercise
Other: home - exercise program
Home exercise program
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.
Time frame: 6 months
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
Time frame: 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
Time frame: 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
Time frame: 6 months
| Milestone | Intervention Group |
|---|---|
| Started | 7 |
| Completed | 1 |
| Not completed | 6 |
we will evaluate how many exercise sessions patients do at home versus what was purposed to the patient.
No measurements were reported for this outcome.
evaluation of the change from baseline of a cross-section area of the multifidus muscle measured by ultrasound
No measurements were reported for this outcome.
evaluation of the change from baseline of a cross-section area of the multifidus muscle measured by physical exam maneuvers
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
Collected over 1 year from the time a subject was enrolled. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Intervention Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Intervention Group |
|---|---|
| Female | 0 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | Intervention Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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Plan to share: No
This study is terminated, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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