A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis and Back Pain
Phase: NA
Conditions: Multiple Sclerosis, Back Pain
Sponsor: University of Arkansas

Title: 
Pilot Project for Multifidus Muscle Evaluation in Patients with Multiple Sclerosis and Back 
Pain 
PI: 
Erika Santos Horta, MD 
Institution: University of Arkansas for Medical Sciences 
 
Version #: 3 
Protocol 
IRB# 263068 
Date: 12/27/2021 
Page 1 
Protocol template version dated 04.16.2021 
 
 
 
Study Title: A Pilot Project for Multifidus Muscle Evaluation in Patients with 
Multiple Sclerosis and Back Pain 
 
 
Principal Investigator:  
Erika Santos Horta 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 721-5 
Little Rock, AR 72205 
Telephone:  501.686.8530 
Email:  esantoshorta@uams.edu 
 
 
Sub-Investigator (s): 
Johnathan Goree 
University of Arkansas for Medical Sciences 
501 Jack Stephens Drive, Mail Slot # 515 
Little Rock, AR 72205 
Telephone:  501-686-8818 
Email: jhgoree@uams.edu 
 
Leah Tobey 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot #798 
Little Rock, AR, 72205 
Telephone: 501-603-1299 
Email: lrtobey@uams.edu 
 
Study location 
University of Arkansas for Medical Sciences 
4301 W. Markham Street  
Little Rock, AR 72205 
 
 

Title: 
Pilot Project for Multifidus Muscle Evaluation in Patients with Multiple Sclerosis and Back 
Pain 
PI: 
Erika Santos Horta, MD 
Institution: University of Arkansas for Medical Sciences 
 
Version #: 3 
Protocol 
IRB# 263068 
Date: 12/27/2021 
Page 2 
Protocol template version dated 04.16.2021 
Background and Rationale 
Multiple sclerosis (MS) is an inflammatory disease affecting over 400,000 Americans 
that causes brain, optic nerve and spinal cord demyelination culminating in neurological 
symptoms.1,2 Currently, MS is the most common non-traumatic cause of disability in 
patients between 20 to 50 years old.1,2  Over 80% of MS patients have pain that largely 
affects their physical and mental quality of life, increasing disability.1,2 Almost one-half of 
patients with MS and pain report that it interferes with social activities, work, or sleep.1 
As there is no cure for MS, approaches that improve quality of life while decreasing pain 
are needed.  Moderate physical exercise has anti-inflammatory effects and decrease 
the sensation of pain in patients with MS, as it brings other benefits as better bone 
health and improvement in fatigue and balance.2 
Low back pain is present in 42-52% of MS patients, reaching 76% of patients in a 
French cohort.3 The multifidus muscle stabilizes the lumbar spine and its atrophy is 
associated to chronic back pain.4,5 Oriented rehabilitation can increase the size and 
control of this muscle, improving lower back pain.6,7  
As physical exercise can increase multifidus muscle performance and it has beneficial 
impact in MS, we propose a pilot study to evaluate the feasibility of a home-exercise 
program for the diagnosis and treatment of low back pain in MS patients focused on the 
multifidus muscle. If shown to be feasible, this novel tool can be taught in person or in 
online appointments, adding to the care of MS patients. 
Specific Aims 
We propose a pilot study to evaluate the feasibility of a home-exercise program for the 
treatment of low back pain in MS patients that are not pregnant or do not have a prior 
diagnosis of lumbar radiculopathy or fibromyalgia. This novel tool would target the 
multifidus muscle and could be taught in person or in online appointments.  
Aims/Objectives 
• Primary aim: study the feasibility of a home-exercise program in patients with MS 
younger then 50 years old with expanded disability status scale (EDSS) between 
1.5 to 5.5.8 Feasibility will be evaluated by the percentage of patients that finish 
the study as also by the compliance measured in hours with the home-exercise 
program. 
• 
Secondary aim: qualify the multifidus dysfunction in patients with MS through 
evaluation of the cross-section area of the multifidus muscle measured by 
ultrasound at the beginning and end of the study, and by physical exam 
maneuvers (multifidus lift and prone instability tests). 

Title: 
Pilot Project for Multifidus Muscle Evaluation in Patients with Multiple Sclerosis and Back 
Pain 
PI: 
Erika Santos Horta, MD 
Institution: University of Arkansas for Medical Sciences 
 
Version #: 3 
Protocol 
IRB# 263068 
Date: 12/27/2021 
Page 3 
Protocol template version dated 04.16.2021 
• 
Exploratory aim: 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.9 
Study Design and Procedures 
This is a prospective pilot project to evaluate the feasibility of a home-exercise program 
to improve the function of the multifidus muscle with the intention to decrease back pain 
in patients with Multiple Sclerosis. Figure 1 summarizes the study design and 
procedures. 
Figure 1 
PROMIS: Patient-Reported Outcomes Measurement Information System, US : 
ultrasound, PE: Physical exam, PT: physical Therapy. 
Adult patients with MS and back pain, further described in the study population section, 
will be asked to participate in this study during an appointment with their neuro-
immunologist. It is standard of care to refer patients with back pain to the pain clinic. 
After patient consent at the neuro-immunology appointment, the study participant will be 
contacted by UAMS Pain clinic staff for an appointment.  In that appointment, the 
participant will fill PROMIS scale that evaluates patient’s quality of life, depression 
symptoms and pain levels.It is standard of care to ask patients regarding pain and how 
pain affects their mood and their daily life. In this study, we are standardizing those 
questions with PROMIS scale. 
Next, the participant will undergo a physical exam that will include standard of care 
physical exam plus  physical maneuvers that evaluate multifidus muscle performance.  
After that, a physical therapist, who is a pain clinc staff,  will teach a series of exercises 
focused at this muscle. This is not standard of care, and it is specific for the patients that 
are enrolled in this study.  
Neuro-immunology 
appointment
Consent
PT Appointment
PROMIS
US
PE
Teach Home Exercises
Home Exercises
12 weeks
Week 2 (+ 2 weeks)
Week 14 (+ 2 weeks)
Week 0
PT Appointment
PROMIS
US
PE
Stephens Spine Center
Stephens Spine Center

Title: 
Pilot Project for Multifidus Muscle Evaluation in Patients with Multiple Sclerosis and Back 
Pain 
PI: 
Erika Santos Horta, MD 
Institution: University of Arkansas for Medical Sciences 
 
Version #: 3 
Protocol 
IRB# 263068 
Date: 12/27/2021 
Page 4 
Protocol template version dated 04.16.2021 
On the same day, an ultrasound will measure the cross-section of the multifidus muscle. 
It is standard of care for patients in the pain clinic undergo ultrasound, for the 
participants in this clinical trial, we will include the multifidus muscle measurements.    
After 3 months of home exercise, but not more than 4 months from the consent, the 
patient will return to repeat the same evaluations, with the same staff. 
Office visits (including physical exam, ultrasound and the PROMIS scale) and physical 
therapy services are considered routine care for this patient population.  Data will be 
collected from patient medical record for research.   
The study will be closed for recruitment after ten patients complete the final 
assessment. Data analysis will then start. Medical charts will be reviewed in all patients 
that gave consent. The review of the medical charts will finish after one year of study 
enrollment. Therefore, patient participation will be less than 2 years.   
 
Study Population 
Patients following in the two neuro-immunology clinics at UAMS will be recruited to this 
study. It is protocol in the neuro-immunology clinic to ask patients with MS about pain. 
An email to other UAMS neurologists as also neurologists that are outside of UAMS will 
be sent to advertise that UAMS will be providing this pilot project. If their patients want 
to participate to this program, a referral will be needed for those patients to be seen in 
the neuro-immunology clinic. 
The study population will comprise of adult patients with MS who have back pain and 
that are following at the neuro-immunology clinic at University of Arkansas for Medical 
Sciences (UAMS).  We anticipate including up to 10 participants in this pilot study. 
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. 

Title: 
Pilot Project for Multifidus Muscle Evaluation in Patients with Multiple Sclerosis and Back 
Pain 
PI: 
Erika Santos Horta, MD 
Institution: University of Arkansas for Medical Sciences 
 
Version #: 3 
Protocol 
IRB# 263068 
Date: 12/27/2021 
Page 5 
Protocol template version dated 04.16.2021 
• 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  
Risks and Benefits 
A risk to study participants is the potential for loss of confidentiality of study data.  
Measures to protect the confidentiality of study data will be implemented as described in 
the Data Handling and Recordkeeping section below.  
Another potential risk is discomfort during the home-exercises. This will be low-risk. All 
exercises are low impact, and they will be taught by a physical therapist and can be 
reviewed and any moment through an app that patient will download.  
Potential benefits include decrease in low back pain and improve in stabilization of the 
spine and in balance, as gait. 
Data Handling and Recordkeeping 
The Principal Investigator will carefully monitor study procedures to protect the safety of 
research subjects, the quality of the data and the integrity of the study. 
When a participant enrolls in the study, a registration form will be completed by the 
physical therapist in their appointment. A study file containing the subject’s name, 
medical record number, date of birth, sex, phone number, and address will be created. 
All study participant materials will kept at the Stephen’s Spine Center. All questionnaires 
answered will be scanned into the participants’ study files and electronic medical chart. 
Data will be collected from the patient’s medical record. 
A password-protected electronic file in a safe digital UAMS-maintained server will be 
used to store and manage data that include demographics, relevant personal 
information, diagnosis, current and prior treatments, and questionnaire results. The 
Principal Investigator, Dr.  Horta, will carefully monitor study procedures to protect the 
safety of research subjects, the quality of the data, and the integrity of the study. Six 
months after the study has been completed, information will be de-identified and stored 
in a safe digital UMAS-maintained server. 
Data Analysis 
Since this is a feasibility study, power analysis was not conducted.  
Specific Aim 1: Primary aim: study the feasibility of a home-exercise program in patients 
with MS younger then 50 years old with expanded disability status scale between 1.5 to 
5.5. 

Title: 
Pilot Project for Multifidus Muscle Evaluation in Patients with Multiple Sclerosis and Back 
Pain 
PI: 
Erika Santos Horta, MD 
Institution: University of Arkansas for Medical Sciences 
 
Version #: 3 
Protocol 
IRB# 263068 
Date: 12/27/2021 
Page 6 
Protocol template version dated 04.16.2021 
Data Analysis Strategy: Analysis will be descriptive. Feasibility will be evaluated by the 
percentage of patients that finish the study as also by the compliance in logged hours of 
exercise.   
Specific Aim 2: qualify the multifidus dysfunction in patients with MS through evaluation 
of the cross-section area of the multifidus muscle measured by ultrasound at the 
beginning and end of the study, and by multifidus lift test and prone instability)  
Data Analysis Strategy: As there is no literature in the evaluation of multifidus muscle in 
patients with MS, this will be a qualitative description of cross-section area and muscle 
performance on physical exam.  
Specific Aim 3: 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. Variables to also be considered will be 
EDSS of the patient.  
Data Analysis Strategy: multiple linear regression will be used to evaluate if there is an 
association between the change in the multifidus cross-section area with compliance 
with home-exercise program, EDSS and pain level.  ROC curve analysis will be done 
evaluating average hours of exercise per week and change in the cross-section area of 
a muscle.  
This pilot project will end after 10 patients finish the home-exercise program of after one 
year. 
Ethical Considerations 
This study will be conducted in accordance with all applicable government regulations 
and University of Arkansas for Medical Sciences research policies and procedures. This 
protocol and any amendments will be submitted and approved by the IRB as required. 
Patients will not be compensated.  
The formal consent of each subject, using IRB-approved consent forms, will be obtained 
before any study procedures. All subjects for this study will be provided a paper consent 
form describing this study in language understandable to the study population. Consent 
materials will provide sufficient information for subjects to make an informed decision 
about their participation in this study. The person obtaining consent will thoroughly 
explain what the subjects need to know about the study, including study requirements, 
study risks and benefits, and possible alternative treatment(s).   
The consent process will take place during their neuroimmunology clinic appointment. 
Participation privacy will be maintained and questions regarding participation will be 
answered. No coercion or undue influence will be used in the consent process. This 
consent form must be signed by the subject. The participant will receive a paper copy of 

Title: 
Pilot Project for Multifidus Muscle Evaluation in Patients with Multiple Sclerosis and Back 
Pain 
PI: 
Erika Santos Horta, MD 
Institution: University of Arkansas for Medical Sciences 
 
Version #: 3 
Protocol 
IRB# 263068 
Date: 12/27/2021 
Page 7 
Protocol template version dated 04.16.2021 
the signed consent form and the informed consent process will be documented in the 
research record. 
Dissemination of Data 
Results of this study may be used for presentations, posters, and publications. The 
publications will not contain any identifiable information that could be linked to a 
participant. The study will be listed on clinicaltrials.gov in accordance with FDA 
requirements. The final, anonymized dataset will be made publicly available at the 
clinicaltrials.gov website. 
 
 

Title: 
Pilot Project for Multifidus Muscle Evaluation in Patients with Multiple Sclerosis and Back 
Pain 
PI: 
Erika Santos Horta, MD 
Institution: University of Arkansas for Medical Sciences 
 
Version #: 3 
Protocol 
IRB# 263068 
Date: 12/27/2021 
Page 8 
Protocol template version dated 04.16.2021 
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3.  
Massot C, Donze C, Guyot MA, Leteneur S. Low back pain in patients with 
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4.  
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