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Active, Not Recruiting

NCT Number: NCT04535479

Dry Needling for Spasticity in 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29405, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2020
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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