Dry Needling for Spasticity in Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04535479
• Other study ID #: 00095077-A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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