Dry Needling for Spasticity in Stroke

NCT04535479 | Active Not Recruiting

• 1 other identifier: 00095077-A
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Muscle Spasticity

Keywords

Dry Needling; Nervous System; Central Nervous System

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Change in ability to move the arm or leg as measured by the Fugl-Meyer Assessment (FMA)

  baseline, 90 minutes after DDN, and 72 hours after DDN

• Change in spasticity as measured by the Modified Ashworth Scale (mAS)

  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)

  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

  baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN

Study Arms (2)

Individuals with spasticity resulting from stroke

EXPERIMENTAL

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

Individuals with no known neurological injury

EXPERIMENTAL

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

Interventions

Dry Needling BEHAVIORAL

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.

Individuals with no known neurological injury; Individuals with spasticity resulting from stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29405, United States

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity; Neurologic Manifestations

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Aiko K Thompson, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 2, 2020
• Study Start: September 8, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)