Functional Intermuscular Reduction of Spasticity (MS-FIRST)

University of Oklahoma (OU)

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: dry needling

Study type: Observational

Funder types: Other

Identifiers

NCT04403594

19-21

Details and patient eligibility

About

Investigators will use muscular dry needling in the calf of one lower extremity, followed by treadmill training with functional electrical stimulation.

Full description

This study will be the first to combine a novel two-pronged approach to the management of spasticity (tightness of the muscle) in the calf muscles. First, investigators will decrease spasticity in an innovative way through dry needling. Second, investigators will follow this spasticity reduction technique using external electrical stimulation applied to the calf, while the participant walks on a harnessed treadmill (for safety). The investigators believe modulating tone in the calf with dry needling will allow for improved strength with electrical stimulation, while simultaneously improving the efficiency of the muscles during walking. The investigators hypothesize that decreasing spasticity will result in enhanced gait efficiency, and lower fatigue, all while allowing the participant to meet their personal mobility goals.10 The investigators are proposing an innovative study design. Assessing changes in muscle spasticity using electromyography and the Modified Ashworth scale before and after each portion of our two-pronged intervention will enable them to understand the immediate effects of dry needling, as well as the combined effects of function electrical stimulation with with treadmill training. Following the intervention assessments with pre-post functional tests will allow us to determine long term changes. This proposal offers a unique approach to management of spasticity in people with Multiple Sclerosis (MS), with the advantage of being minimally invasive and inexpensive. Results of this pilot study will inform the potential use in MS, and will allow for a larger study examining optimal intervention parameters for future use.

Enrollment: 16 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of MS based on MRI
2. Ability walk 25 feet
3. Spasticity of one lower extremity

Exclusion criteria

1. Blood clot within the last 6 months
2. Bleeding disorder
3. Active cancer
4. Botox in the lower extremities within 6 months

Trial design

16 participants in 1 patient group

MS with spasticity of one lower extremity

Description:

A person diagnosed with Multiple Sclerosis and spasticty of one lower extremity. The person must be able to walk 25 feet and cannot have had Botox in the lower extremity on the last 6 months.

Treatment:

Other: dry needling