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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 90 minutes after ddn, and 72 hours after ddn
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, immediately after ddn, 90 minutes after ddn, and 72 hours after ddn
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately after ddn, 90 minutes after ddn, and 72 hours after ddn
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
968 Previous Clinical Trials
7,399,668 Total Patients Enrolled
72 Trials studying Stroke
62,144 Patients Enrolled for Stroke
Aiko K Thompson, PhDPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
44 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My diabetes is not under control.My motor nerves are damaged and don't respond well to treatment.I have a severe fear of needles.I am over 18 and do not have any known brain injuries or conditions.I had a stroke over a year ago, have stable health, and experience stiffness in my ankle or wrist.I have a condition affecting my blood vessels.I am under 18 years old.I experience unusual bleeding.My immune system is weak.I am experiencing anxiety or distress.I have a heart condition such as a past heart attack, heart failure, or use a pacemaker.I have swelling in my arm or leg due to lymphedema.I am able to understand and follow the study's requirements.I have a history of epilepsy.I am allergic to certain metals.
Research Study Groups:
This trial has the following groups:- Group 1: Individuals with spasticity resulting from stroke
- Group 2: Individuals with no known neurological injury
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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