Dry Needling for Spasticity in Stroke

  • STATUS
    Recruiting
  • days left to enroll
    21
  • participants needed
    40
  • sponsor
    Medical University of South Carolina
Updated on 14 November 2021
Accepts healthy volunteers

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.

Details
Condition Spasticity, strokes, cerebral, cerebrovascular accidents, Stroke, Cerebrovascular accident
Treatment Dry needling
Clinical Study IdentifierNCT04535479
SponsorMedical University of South Carolina
Last Modified on14 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

For adults with no known neurological conditions
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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