Multiple SclerosisNCT05427045
A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis
A study testing home - exercise program in people with Multiple Sclerosis and Back Pain, run by University of Arkansas at 1 site in United States.
Trial summary
This research study plans to evaluate if multifidus muscle dysfunction is associated with back pain in patients with Multiple Sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis, Back Pain
- What is being tested?
- home - exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 5 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis and Back Pain
This research study plans to evaluate if multifidus muscle dysfunction is associated with back pain in patients with Multiple Sclerosis (MS).
Read the 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.
- Conditions
- Multiple Sclerosis, Back Pain
- Being tested
- home - exercise program
- Medical subject headings
- Multiple Sclerosis, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home - exercise programOther
Home exercise program
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Adult patients < 50 years old who have multiple sclerosis and back pain who are undergoing home exercise Receives: Other: home - exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 May 2022
- Primary completion5 May 2023
- Study completion5 May 2023
Why it stopped: Incomplete follow up, low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erika Santos Horta, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427045
- Sponsor's protocol ID
- 263068
- Status last verified
- Feb 2024
- First submitted
- 23 May 2022
- Last updated
- 7 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis and Back Pain
- ClinicalTrials.gov ID
- NCT05427045
- Acronym / sponsor ID
- 263068
- Conditions
- Multiple Sclerosis, Back Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Incomplete follow up, low enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Posted 7 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: home - exercise programAdult patients < 50 years old who have multiple sclerosis and back pain who are undergoing home exercise |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home - exercise programHome exercise program | Other | Intervention group |
Primary outcome
Study the Compliance of a Home-exercise Program in Patients With MS
Time frame: 6 months
we will evaluate how many exercise sessions patients do at home versus what was purposed to the patient.
3 secondary outcomes
Qualify the Multifidus Dysfunction in Patients With MS - Ultrasound
Time frame: 6 months
Qualify the Multifidus Dysfunction in Patients With MS - Physical Exam
Time frame: 6 months
Correlation Between Compliance and Plain and Size of Muscle
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Santos Horta, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home - exercise program in people with Multiple Sclerosis and Back Pain, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the Compliance of a Home-exercise Program in Patients With MS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.