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Completed

NCT Number: NCT04403594

Functional Intermuscular Reduction of Spasticity

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of MS based on MRI
  • Ability walk 25 feet
  • Spasticity of one lower extremity

Exclusion criteria

  • Blood clot within the last 6 months
  • Bleeding disorder
  • Active cancer
  • Botox in the lower extremities within 6 months

Treatment and study plan

dry needling

Other

dry needling followed by functional electrical stimulation and treadmill training

Other names: functional electrical stimulation

Primary outcomes

  1. 6 minute walk test

    Time frame: up to 7 weeks

    distance walked over 6 minutes assessed at the start of the study and after 6 weeks.

  2. 25-foot walk

    Time frame: up to 7 weeks

    time to walk 25 feet assessed at the start of the study and after 6 weeks.

  3. Berg Balance Scale

    Time frame: up to 7 weeks

    Balance test conducted at the start of the study and after 6 weeks.

  4. Modified Fatigue Impact Scale

    Time frame: up to 7 weeks

    patient-reported questionnaire collected at the start of the study and after 6 weeks.

  5. Toe taps on force plate

    Time frame: up to 7 weeks

    number of toe taps in 10 seconds counted at the start of the study and after 6 weeks.

  6. EMG data of both lower extremities

    Time frame: up to 7 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Oklahoma Medical Research Foundation

Registry information

Official study title

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

Acronym: MS-FIRST

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 27, 2020
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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