StrokeNCT04535479
Dry Needling for Spasticity in Stroke
A study testing Dry Needling in people with Stroke and Muscle Spasticity, run by Medical University of South Carolina at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Muscle Spasticity
- What is being tested?
- Dry Needling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2020to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29405
About this study
Official title: Neurophysiological Characterization of Dry Needling in People With Spasticity Due to Stroke
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.
- Conditions
- Stroke, Muscle Spasticity
- Being tested
- Dry Needling
- Keywords
- Dry Needling, Nervous System, Central Nervous System
- Medical subject headings
- Stroke, Muscle Spasticity, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingBehavioural
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 a muscle and relieve pain.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with spasticity resulting from stroke | Experimental | 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. Receives: Behavioral: Dry Needling |
| Individuals with no known neurological injury | Experimental | 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. Receives: Behavioral: Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the H-reflex amplitude in response to nerve stimulation
H-reflex amplitude (mV) reflects the excitability of its reflex pathway. Changes in the H-reflex amplitude indicate that DDN influences the spinal reflex excitability. In the lower extremity this will be measured in the tibialis anterior and the triceps surae. In the upper extremity this will be measured in flexor carpi ulnaris and flexor carpi radialis.
Measured: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
2. Changes in cutaneous reflexes elicited by non-noxious stimulation of cutaneous or mix nerves
Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.
Measured: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
3. Changes in perception of cutaneous stimuli as measured by perception and radiating threshold of cutaneous nerve stimulation
Changes in thresholds of cutaneous nerve stimulation would imply that DDN can affect the perception of cutaneous input.
Measured: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
Secondary outcomes (4)
Change in ability to move the arm or leg as measured by the Fugl-Meyer Assessment (FMA)
An increase in the FMA score indicates better movement of the arm or leg.
Measured: baseline, 90 minutes after DDN, and 72 hours after DDN
Change in spasticity as measured by the Modified Ashworth Scale (mAS)
The mAS score ranges from 0: normal muscle tone to 4: rigid in flexion or extension. A decrease in mAS indicates decreased spasticity.
Measured: baseline, 90 minutes after DDN, and 72 hours after DDN
Change in the ability to move the limb as measured by range of motion (ROM)
ROM is measured in degrees using a standard goniometer. Increased ROM, which will be measured both passively (moved by the assessor) and actively (participant moves the arm themselves), indicates improved ability to move the limb.
Measured: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
Change in pain level as measured by the visual analog scale (VAS) for pain
Pain is rated by the participant on a scale from 0 (no pain) to 10 (worst pain imaginable). Decreased score on the VAS for pain indicates decreased pain.
Measured: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start8 Sep 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiko Thompson, Medical University of South Carolina
- Investigators
- Aiko K Thompson, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535479
- Sponsor's protocol ID
- 00095077-A
- Status last verified
- Jul 2026
- First submitted
- 27 Aug 2020
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Characterization of Dry Needling in People With Spasticity Due to Stroke
- ClinicalTrials.gov ID
- NCT04535479
- Acronym / sponsor ID
- 00095077-A
- Conditions
- Stroke, Muscle Spasticity
- Keywords
- Dry Needling, Nervous System, Central Nervous System
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with spasticity resulting from stroke | Experimental | Behavioral: Dry NeedlingThis 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. |
| Individuals with no known neurological injury | Experimental | Behavioral: Dry NeedlingThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry NeedlingDry 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 a muscle and relieve pain. | Behavioural | Individuals with no known neurological injury, Individuals with spasticity resulting from stroke |
Primary outcome
Changes in the H-reflex amplitude in response to nerve stimulation
Time frame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
H-reflex amplitude (mV) reflects the excitability of its reflex pathway. Changes in the H-reflex amplitude indicate that DDN influences the spinal reflex excitability. In the lower extremity this will be measured in the tibialis anterior and the triceps surae. In the upper extremity this will be measured in flexor carpi ulnaris and flexor carpi radialis.
2. Changes in cutaneous reflexes elicited by non-noxious stimulation of cutaneous or mix nerves
Time frame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
Changes in the cutaneous reflex amplitudes would indicate that DDN can influence the spinal processing of cutaneous information.
3. Changes in perception of cutaneous stimuli as measured by perception and radiating threshold of cutaneous nerve stimulation
Time frame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
Changes in thresholds of cutaneous nerve stimulation would imply that DDN can affect the perception of cutaneous input.
4 secondary outcomes
Change in ability to move the arm or leg as measured by the Fugl-Meyer Assessment (FMA)
Time frame: baseline, 90 minutes after DDN, and 72 hours after DDN
Change in spasticity as measured by the Modified Ashworth Scale (mAS)
Time frame: baseline, 90 minutes after DDN, and 72 hours after DDN
Change in the ability to move the limb as measured by range of motion (ROM)
Time frame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
Change in pain level as measured by the visual analog scale (VAS) for pain
Time frame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aiko K Thompson, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling in people with Stroke and Muscle Spasticity, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the H-reflex amplitude in response to nerve stimulation (time frame: baseline, immediately after DDN, 90 minutes after DDN, and 72 hours after DDN). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.