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Functional Intermuscular Reduction of Spasticity (MS-FIRST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04403594
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
Oklahoma Medical Research Foundation
Information provided by (Responsible Party):
University of Oklahoma

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

Condition or disease Intervention/treatment
Multiple Sclerosis Other: dry needling

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.

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Study Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Functional Intermuscular Reduction of SpasTicity in MS (MS-FIRST)
Actual Study Start Date : August 19, 2019
Estimated Primary Completion Date : December 18, 2020
Estimated Study Completion Date : December 18, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MS with spasticity of one lower extremity
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.
Other: dry needling
dry needling followed by functional electrical stimulation and treadmill training
Other Name: functional electrical stimulation




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with a diagnosis of MS and spasticity
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04403594


Contacts
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Contact: Bobbette Miller, DPT 715-581-4415 bobbette-miller@ouhsc.edu
Contact: Shirley James, PhD 405-271-2132 ext 46812 shirley-james@ouhsc.edu

Locations
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United States, Oklahoma
Oklahoma Medical Research Foundation Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Bobbette Miller, DPT       bobbette-miller@ouhsc.edu   
Contact: Shirley James, PhD    405-271-2131 ext 46812    shilrey-james@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
Oklahoma Medical Research Foundation
Investigators
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Principal Investigator: Shirley James, PhD University of Oklahoma
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT04403594    
Other Study ID Numbers: 19-21
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases