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Incomplete follow up, low enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Adult patients < 50 years old who have multiple sclerosis and back pain who are undergoing home exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home - exercise program | Other | Home exercise program |
|
| 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 |
| 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Erika Santos Horta, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Adult Patients < 50 years old who have multiple sclerosis and back pain who are undergoing home exercise |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Other: home - exercise program Home exercise program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patient never returned to Physical Therapy - no data was collected | Posted | 6 months |
|
|
1 year from the time a subject was enrolled
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Adult patients < 50 years old who have multiple sclerosis and back pain who are undergoing home exercise home - exercise program: Home exercise program |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Santos-Horta | UArkansas | 507-250-5880 | ESantoshorta@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 27, 2021 | Jul 25, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | No subject completed study- No data was collected as subject did not return for visit | Posted | 6 months | Change on Cross section | Change on Cross section |
|
|
| 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 | Subject never returned for PT- no data was collected | Posted | 6 months |
|
|
| Secondary | 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 | Subject never returned to clinic to complete pain score- No data was collected | Posted | 6 months |
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |