Dry Needling for Spasticity in Stroke

NCT ID: NCT04535479

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-08
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dry Needling

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Dry Needling

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Aiko Thompson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aiko K Thompson, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

00095077-A

Identifier Type: -

Identifier Source: org_study_id