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Dry Needling for Spasticity in Stroke

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ClinicalTrials.gov Identifier: NCT04535479
Recruitment Status : Recruiting
First Posted : September 2, 2020
Last Update Posted : November 8, 2021
Sponsor:
Information provided by (Responsible Party):
Aiko Thompson, Medical University of South Carolina

Study Description
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Brief Summary:

The study team is recruiting 20 adults with spasticity due to chronic stroke and 20 adults with no neurological injuries for a 2 day study. In people with chronic stroke, one of the most common and disabling problems is spasticity (increased muscle tone or muscle stiffness). The purpose of this research study is to examine effects of dry needling on the nervous system (pathways between the muscle, spinal cord, and brain) in people with spasticity due to chronic stroke. Dry needling is a procedure in which a thin, stainless steel needle is inserted into your skin to produce a muscle twitch response. It is intended to release a knot in your muscle and relieve pain.

The total study duration is 2 days. The first visit will take about 3 hours, during which dry needling will take place, and the second visit will take about 1 hour. During both visits you will be asked to participate in examinations of reflexes (muscle responses to non-invasive nerve stimulation) and arm/leg function.


Condition or disease Intervention/treatment Phase
Stroke Muscle Spasticity Behavioral: Dry Needling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neurophysiological Characterization of Dry Needling in People With Spasticity Due to Stroke
Actual Study Start Date : September 8, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Individuals with spasticity resulting from stroke
This is an experimental intervention in which individuals will receive dry needling to relieve spasticity in the target muscle. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to, immediately after, 90 minutes after, and 72 hours after dry needling. These assessments will examine how you move your arm or leg and how your nervous system responds to non-invasive nerve stimulation.
 Behavioral: Dry Needling
Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.
Experimental: Individuals with no known neurological injury
This is an experimental intervention in which individuals will receive dry needling of an arm or leg muscle. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to, immediately after, 90 minutes after, and 72 hours after dry needling. These assessments will examine how you move your arm or leg and how your nervous system responds to non-invasive nerve stimulation.
 Behavioral: Dry Needling
Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in the H-reflex amplitude in response to nerve stimulation [ Time Frame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN ]
    H-reflex amplitude (mV) reflects the excitability of its reflex pathway. Changes in the H-reflex amplitude indicate that DDN influences the spinal reflex excitability. In the lower extremity this will be measured in the tibialis anterior and the triceps surae. In the upper extremity this will be measured in flexor carpi ulnaris and flexor carpi radialis.

  2. 2. Changes in cutaneous reflexes elicited by non-noxious stimulation of cutaneous or mix nerves [ Time Frame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN ]
    Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.

  3. 3. Changes in perception of cutaneous stimuli as measured by perception and radiating threshold of cutaneous nerve stimulation [ Time Frame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN ]
    Changes in thresholds of cutaneous nerve stimulation would imply that DDN can affect the perception of cutaneous input.


Secondary Outcome Measures :
  1. Change in ability to move the arm or leg as measured by the Fugl-Meyer Assessment (FMA) [ Time Frame: baseline, 90 minutes after DDN, and 72 hours after DDN ]
    An increase in the FMA score indicates better movement of the arm or leg.

  2. Change in spasticity as measured by the Modified Ashworth Scale (mAS) [ Time Frame: baseline, 90 minutes after DDN, and 72 hours after DDN ]
    The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity.

  3. Change in the ability to move the limb as measured by range of motion (ROM) [ Time Frame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN ]
    ROM is measured in degrees using a standard goniometer. Increased ROM, which will be measured both passively (moved by the assessor) and actively (participant moves the arm themselves), indicates improved ability to move the limb.

  4. Change in pain level as measured by the visual analog scale (VAS) for pain [ Time Frame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN ]
    Pain is rated by the participant on a scale from 0 (no pain) to 10 (worst pain imaginable). Decreased score on the VAS for pain indicates decreased pain.

  5. Changes in brain activity as measured by electroencephalography (EEG) [ Time Frame: baseline, during DDN, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN ]
    Changes in EEG (brain wave) activity in response to DDN would suggest that the intervention has an effect on the central nervous system and the brain. Knowing if and how the brain activity changes will help investigators understand the potential impact of this type of intervention.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For adults with no known neurological conditions:

  • ≥18 years old
  • no known neurological injuries.

For individuals after stroke:

  • neurologically stable for >6 months (and >1 yr post stroke)
  • medical clearance to participate
  • unilateral ankle and/or wrist spasticity, confirmed by Modified Ashworth Scale (MAS) > 1 and the presence of spastic hyperreflexia

Exclusion Criteria:

  • motoneuron injury (i.e. the neurons that give rise to the axons innervating the muscles) with inadequate response to stimulation
  • a cardiac condition ( history of myocardial infarction, congestive heart failure, pacemaker use, coronary artery disease, atrial fibrillation, congenital heart disease, uncontrolled hypertension)
  • a medically unstable condition (including temporary infections and pregnancy)
  • age <18 years old
  • cognitive impairment sufficient to interfere with informed consent or successful completion of the protocol
  • metal allergies
  • needle phobias
  • lymphedema over a limb (due to risk of infection/cellulitis)
  • abnormal bleeding tendencies
  • compromised immune system
  • vascular disease
  • uncontrolled diabetes
  • history of epilepsy (as DDN generates strong somatosensory sensation)
  • anxiety disorders or in distress.
Contacts and Locations
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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): NCT04535479


Contacts
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Contact: Blair Dellenbach, MSOT 843-792-6313 stecb@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29405
Contact: Blair Dellenbach, MSOT    843-792-6313    stecb@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Aiko K Thompson, PhD Medical University of South Carolina
More Information
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Responsible Party: Aiko Thompson, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04535479    
Other Study ID Numbers: 00095077-A
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: November 8, 2021
Last Verified: November 2021
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
Keywords provided by Aiko Thompson, Medical University of South Carolina:
Dry Needling
Nervous System
Central Nervous System
Additional relevant MeSH terms:
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Muscle Spasticity
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations