Functional Intermuscular Reduction of Spasticity

Multiple Sclerosis Clinical Trial

— MS-FIRST  

Official title:

Functional Intermuscular Reduction of SpasTicity in MS (MS-FIRST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04403594
• Other study ID #: 19-21
• Status: Completed
• Start date: August 19, 2019
• Est. completion date: April 18, 2021

Study information

• Verified date: September 2021
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 18, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Other:
• dry needling
dry needling followed by functional electrical stimulation and treadmill training

Locations

Country	Name	City	State
United States	Oklahoma Medical Research Foundation	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Oklahoma Medical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walk test	distance walked over 6 minutes assessed at the start of the study and after 6 weeks.	up to 7 weeks
Primary	25-foot walk	time to walk 25 feet assessed at the start of the study and after 6 weeks.	up to 7 weeks
Primary	Berg Balance Scale	Balance test conducted at the start of the study and after 6 weeks.	up to 7 weeks
Primary	Modified Fatigue Impact Scale	patient-reported questionnaire collected at the start of the study and after 6 weeks.	up to 7 weeks
Primary	Toe taps on force plate	number of toe taps in 10 seconds counted at the start of the study and after 6 weeks.	up to 7 weeks
Primary	EMG data of both lower extremities	Electromyography (EMG) will be conducted at the start of the study and after 6 weeks. EMG is an electrodiagnostic technique for evaluating and recording the electrical activity produced by skeletal muscles. This is completed using electrodes that are placed on the skin, which detects the electric potential generated by muscle cells when these cells are electrically or neurologically activated. These action potentials are measured and recorded on a computer.	up to 7 weeks