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Dry Needling for Muscle Spasms After Stroke

N/A
Waitlist Available
Led By Aiko K Thompson, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 90 minutes after ddn, and 72 hours after ddn
Awards & highlights

Study Summary

This trial is testing the effects of dry needling on spasticity in people with chronic stroke.

Who is the study for?
This trial is for adults over 18 years old with muscle stiffness from a stroke that happened more than a year ago and are medically stable. It's also for those without neurological injuries. People can't join if they have certain medical conditions like uncontrolled diabetes, bleeding issues, severe anxiety, metal allergies, or heart problems.Check my eligibility
What is being tested?
The study tests dry needling—a technique where a thin needle is used to relieve muscle knots and pain in people with spasticity after stroke. Participants will undergo this procedure once and then be evaluated on reflexes and limb function over two days.See study design
What are the potential side effects?
Dry needling may cause some discomfort at the needle site, minor bleeding or bruising, temporary soreness in the muscles treated, or an allergic reaction if one has metal allergies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and do not have any known brain injuries or conditions.
Select...
I had a stroke over a year ago, have stable health, and experience stiffness in my ankle or wrist.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately after ddn, 90 minutes after ddn, and 72 hours after ddn
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediately after ddn, 90 minutes after ddn, and 72 hours after ddn for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
2. Changes in cutaneous reflexes elicited by non-noxious stimulation of cutaneous or mix nerves
3. Changes in perception of cutaneous stimuli as measured by perception and radiating threshold of cutaneous nerve stimulation
Changes in the H-reflex amplitude in response to nerve stimulation
Secondary outcome measures
Change in ability to move the arm or leg as measured by the Fugl-Meyer Assessment (FMA)
Pain
Change in spasticity as measured by the Modified Ashworth Scale (mAS)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Individuals with spasticity resulting from strokeExperimental Treatment1 Intervention
This is an experimental intervention in which individuals will receive dry needling to relieve spasticity in the target muscle. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to, immediately after, 90 minutes after, and 72 hours after dry needling. These assessments will examine how you move your arm or leg and how your nervous system responds to non-invasive nerve stimulation.
Group II: Individuals with no known neurological injuryExperimental Treatment1 Intervention
This is an experimental intervention in which individuals will receive dry needling of an arm or leg muscle. The study team will examine the effects of this treatment on the nervous system by performing assessments just prior to, immediately after, 90 minutes after, and 72 hours after dry needling. These assessments will examine how you move your arm or leg and how your nervous system responds to non-invasive nerve stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dry Needling
2020
Completed Phase 2
~1090

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
929 Previous Clinical Trials
7,393,781 Total Patients Enrolled
67 Trials studying Stroke
60,011 Patients Enrolled for Stroke
Aiko K Thompson, PhDPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
44 Total Patients Enrolled

Media Library

Dry Needling (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04535479 — N/A
Stroke Research Study Groups: Individuals with spasticity resulting from stroke, Individuals with no known neurological injury
Stroke Clinical Trial 2023: Dry Needling Highlights & Side Effects. Trial Name: NCT04535479 — N/A
Dry Needling (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04535479 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there room in this research endeavor for additional participants?

"Indeed, the information on clinicaltrials.gov advertises this trial as actively recruiting participants. It was first publicised on September 8th 2020 and most recently modified on July 22nd 2022, with 40 patients sought from one site."

Answered by AI

What objectives are being sought to be achieved with this trial?

"The main outcome of this clinical trial, which will be monitored at baseline, immediately after DDN, 90 minutes afterwards and 72 hours later, is evaluating the participants' perception of cutaneous stimuli using perception thresholds. Other objectives include assessing spasticity with Modified Ashworth Scale (mAS), pain levels via Visual Analog Scale (VAS) and brain activity through Electroencephalography (EEG). A reduction in mAS indicates a decrease in spasticity, lower VAS score signals lowered pain intensity whereas altered EEG patterns signify potential changes to CNS functionality from the intervention."

Answered by AI

What is the enrollment size of this trial thus far?

"Affirmative. The clinicaltrials.gov website shows that this trial, which was published on September 8th 2020, is actively recruiting patients. Approximately 40 individuals must be recruited from 1 specific medical facility."

Answered by AI
~3 spots leftby Jun 2024