Dry Needling for Spasticity in Stroke (NCT04535479) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Dry Needling for Spasticity in Stroke
United States32 participantsStarted 2020-09-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in the H-reflex amplitude in response to nerve stimulation
Timeframe: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
2
2. Changes in cutaneous reflexes elicited by non-noxious stimulation of cutaneous or mix nerves
Timeframe: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
3
3. Changes in perception of cutaneous stimuli as measured by perception and radiating threshold of cutaneous nerve stimulation
Timeframe: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN