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Dry Needling for Spasticity in Stroke

Primary Purpose

Stroke, Muscle Spasticity

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry Needling
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Dry Needling, Nervous System, Central Nervous System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Individuals with spasticity resulting from stroke

Individuals with no known neurological injury

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in the H-reflex amplitude in response to nerve stimulation
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. Changes in cutaneous reflexes elicited by non-noxious stimulation of cutaneous or mix nerves
Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.
3. Changes in perception of cutaneous stimuli as measured by perception and radiating threshold of cutaneous nerve stimulation
Changes in thresholds of cutaneous nerve stimulation would imply that DDN can affect the perception of cutaneous input.

Secondary Outcome Measures

Change in ability to move the arm or leg as measured by the Fugl-Meyer Assessment (FMA)
An increase in the FMA score indicates better movement of the arm or leg.
Change in spasticity as measured by the Modified Ashworth Scale (mAS)
The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity.
Change in the ability to move the limb as measured by range of motion (ROM)
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.
Change in pain level as measured by the visual analog scale (VAS) for pain
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.
Changes in brain activity as measured by electroencephalography (EEG)
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.

Full Information

First Posted
August 27, 2020
Last Updated
July 13, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT04535479
Brief Title
Dry Needling for Spasticity in Stroke
Official Title
Neurophysiological Characterization of Dry Needling in People With Spasticity Due to Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Muscle Spasticity
Keywords
Dry Needling, Nervous System, Central Nervous System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Individuals with spasticity resulting from stroke
Arm Type
Experimental
Arm Description
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.
Arm Title
Individuals with no known neurological injury
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dry Needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the H-reflex amplitude in response to nerve stimulation
Description
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.
Time Frame
baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
Title
2. Changes in cutaneous reflexes elicited by non-noxious stimulation of cutaneous or mix nerves
Description
Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.
Time Frame
baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
Title
3. Changes in perception of cutaneous stimuli as measured by perception and radiating threshold of cutaneous nerve stimulation
Description
Changes in thresholds of cutaneous nerve stimulation would imply that DDN can affect the perception of cutaneous input.
Time Frame
baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
Secondary Outcome Measure Information:
Title
Change in ability to move the arm or leg as measured by the Fugl-Meyer Assessment (FMA)
Description
An increase in the FMA score indicates better movement of the arm or leg.
Time Frame
baseline, 90 minutes after DDN, and 72 hours after DDN
Title
Change in spasticity as measured by the Modified Ashworth Scale (mAS)
Description
The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity.
Time Frame
baseline, 90 minutes after DDN, and 72 hours after DDN
Title
Change in the ability to move the limb as measured by range of motion (ROM)
Description
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.
Time Frame
baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
Title
Change in pain level as measured by the visual analog scale (VAS) for pain
Description
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.
Time Frame
baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
Title
Changes in brain activity as measured by electroencephalography (EEG)
Description
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.
Time Frame
baseline, during DDN, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiko K Thompson, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dry Needling for Spasticity in Stroke

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