Clinical trial NCT04403594: Functional Intermuscular Reduction of Spasticity
Official title: Functional Intermuscular Reduction of SpasTicity in MS (MS-FIRST)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Oklahoma Medical Research Foundation
First posted: 2020-05-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with a diagnosis of MS and spasticity

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 6 minute walk test
timeFrame: up to 7 weeks
measure: 25-foot walk
timeFrame: up to 7 weeks
measure: Berg Balance Scale
timeFrame: up to 7 weeks
measure: Modified Fatigue Impact Scale
timeFrame: up to 7 weeks
measure: Toe taps on force plate
timeFrame: up to 7 weeks
measure: EMG data of both lower extremities
timeFrame: up to 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Shirley James, PhD
role: PRINCIPAL_INVESTIGATOR
References: