Dry Needling for Spasticity in Stroke

Neurophysiological Characterization of Dry Needling in People With Spasticity Due to Stroke

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stroke; Muscle Spasticity
• Intervention / Treatment: Behavioral: Dry Needling

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29405
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
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.	baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
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.	baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 90 minutes after DDN, and 72 hours after DDN
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.	baseline, 90 minutes after DDN, and 72 hours after DDN
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.	baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
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.	baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
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.	baseline, during DDN, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Aiko K Thompson, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Dry Needling; Central Nervous System; Nervous System
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity
• Other Study ID Numbers: 00095077-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No