N/A
N=11
DDN in Stroke--COBRE
Stroke · Spasticity, Muscle · CVA
Bottom Line
View on ClinicalTrials.gov: NCT05196737 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Changes in the H-reflex Amplitude in Response to Nerve Stimulation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dry Needling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the H-reflex Amplitude in Response to Nerve Stimulation |
— | — |
| PRIMARY Changes in Cutaneous Reflexes Elicited by Non-noxious Stimulation of Cutaneous or Mix Nerves |
— | — |
| PRIMARY Changes in Perception of Cutaneous Stimuli as Measured by Perception and Radiating Threshold of Cutaneous Nerve Stimulation |
— | — |
| PRIMARY Ability to Move the Limb as Measured by Range of Motion (ROM) |
0.5; 0; 0; 0.5; 0; 3 | — |
| SECONDARY Ability to Move the Leg as Measured by the Fugl-Meyer Assessment (FMA) Lower Extremity |
22; 20; 24; 19.5; 22.5; 21 | — |
| SECONDARY Change in Spasticity as Measured by the Modified Ashworth Scale (mAS) |
3; 3; 3; 3; 3; 3 | — |
| SECONDARY Change in Pain Level as Measured by the Visual Analog Scale (VAS) for Pain |
— | — |
| SECONDARY Change in Time Needed to Walk 10 Meter (10 m Walk Test) |
9.525; 7.91; 9.515; 8.1; 8.175; 7.57 | — |
Summary
The study team is recruiting 20 adults with spasticity due to chronic stroke for a 7 day study over 2 weeks. 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 the skin to produce a muscle twitch response. It is intended to release a knot in the muscle and relieve pain.
The total study duration is 7 visits over 2 weeks. There will be 4 visits the first week, and 3 visits the second week. The first visit will take about 1.5 hours, during which study staff will determine the best placement of electrodes and create a cast of the participant's leg to aid them in quickly placing the electrodes on the remainder of the visits. The second and fifth visits will last about 3.5 hours, and all other visits will last about 1.5 hours. Dry needling will take place on the fifth visit only. During each visit the participant will be asked to participate in examinations of reflexes (muscle responses to non-invasive nerve stimulation) and leg function.
Eligibility Criteria
Inclusion Criteria
- ≥18 years old
- no known neurological injuries.
- 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
- botox injection in target muscle within 3 months prior to start of study
Data sourced from ClinicalTrials.gov (NCT05196737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.