A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis

NCT05427045 | Terminated Results

• 1 other identifier: 263068
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This research study plans to evaluate if multifidus muscle dysfunction is associated with back pain in patients with Multiple Sclerosis (MS).

Conditions

Multiple Sclerosis; Back Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Qualify the Multifidus Dysfunction in Patients With MS - Ultrasound

  6 months

• Qualify the Multifidus Dysfunction in Patients With MS - Physical Exam

  6 months

• Correlation Between Compliance and Plain and Size of Muscle

  6 months

Study Arms (1)

Intervention group

EXPERIMENTAL

Adult patients \< 50 years old who have multiple sclerosis and back pain who are undergoing home exercise

Other: home - exercise program

Interventions

home - exercise program OTHER

Home exercise program

Intervention group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Back Pain

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Santos-Horta
• Organization: UArkansas

ESantoshorta@uams.edu

507-250-5880

Study Officials

• Erika Santos Horta, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 22, 2022
• Study Start: May 1, 2022
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: November 7, 2024
• Results First Posted: November 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)