Back Pain, Multiple Sclerosis
Conditions
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.
Interventions
OTHERhome - exercise program
Home exercise program
Sponsors
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study the Compliance of a Home-exercise Program in Patients With MS | 6 months | we will evaluate how many exercise sessions patients do at home versus what was purposed to the patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualify the Multifidus Dysfunction in Patients With MS - Ultrasound | 6 months | 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 | 6 months | evaluation of the change from baseline of a cross-section area of the multifidus muscle measured by physical exam maneuvers |
| Correlation Between Compliance and Plain and Size of Muscle | 6 months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Other: home - exercise program Home exercise program | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Intervention Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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.
Time frame: 6 months
Population: Patient never returned to Physical Therapy - no data was collected
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
Time frame: 6 months
Population: Subject never returned to clinic to complete pain score- No data was collected
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
Time frame: 6 months
Population: Subject never returned for PT- no data was collected
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
Time frame: 6 months
Population: No subject completed study- No data was collected as subject did not return for visit