Trial Outcomes & Findings for A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis (NCT NCT05427045)

NCT ID: NCT05427045

Last Updated: 2024-11-07

Results Overview

we will evaluate how many exercise sessions patients do at home versus what was purposed to the patient.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-11-07

Participant Flow

Participant milestones

Measure	Intervention Group Adult Patients \< 50 years old who have multiple sclerosis and back pain who are undergoing home exercise
Overall Study STARTED	7
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intervention Group n=1 Participants Other: home - exercise program Home exercise program
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Patient never returned to Physical Therapy - no data was collected

we will evaluate how many exercise sessions patients do at home versus what was purposed to the patient.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No subject completed study- No data was collected as subject did not return for visit

evaluation of the change from baseline of a cross-section area of the multifidus muscle measured by ultrasound

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Subject never returned for PT- no data was collected

evaluation of the change from baseline of a cross-section area of the multifidus muscle measured by physical exam maneuvers

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Subject never returned to clinic to complete pain score- No data was collected

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

Outcome measures

Outcome data not reported

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Santos-Horta

UArkansas

Phone: 507-250-5880

Email: ESantoshorta@uams.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place