Dry Needling for Muscle Spasms After Stroke

Overseen By Blair Dellenbach, MSOT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Cardiac conditions, Cognitive impairment, Diabetes, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 93

Duration: 1 day

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Dry Needling for muscle spasms after stroke?

Research shows that dry needling can help reduce muscle tightness and improve movement in people who have had a stroke. It has been found to decrease muscle spasticity (tightness) and improve hand function and strength in stroke patients. ^{1 2 3 4 5}

Is dry needling safe for treating muscle spasms after a stroke?

Dry needling is generally well tolerated, but mild to severe complications can occur, such as an acute spinal epidural hematoma (a type of bleeding in the spine). It's important for practitioners to take precautions, especially when needling near the spine. ^{3 4 6 7 8}

How does dry needling treatment differ from other treatments for muscle spasms after stroke?

Dry needling is unique because it involves inserting a needle into muscle trigger points without using any drugs, which can immediately reduce muscle tightness and improve range of motion in spastic muscles after a stroke. ^{1 3 4 9 10}

What is the purpose of this trial?

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.

Research Team

Aiko K Thompson, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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.

Inclusion Criteria

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.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive dry needling treatment and undergo assessments of reflexes and limb function

1 day

2 visits (in-person)

Follow-up

Participants are monitored for changes in reflexes, limb movement, pain levels, and brain activity after treatment

3 days

Assessments at baseline, immediately after, 90 minutes after, and 72 hours after treatment

Treatment Details

Interventions

• Dry Needling

Trial Overview 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.

Participant Groups

Group I: Individuals with spasticity resulting from stroke Experimental Treatment 1 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 injury Experimental Treatment 1 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.

Dry Needling is already approved in United Kingdom, United States for the following indications:

Approved in United Kingdom as Dry Needling for:

• Knee osteoarthritis pain management
• Muscle strength improvement
• Leg function enhancement

Approved in United States as Dry Needling for:

• Chronic knee pain relief
• Musculoskeletal pain management
• Myofascial pain syndrome treatment

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Findings from Research

In a study involving nine rabbits, dry needling of myofascial trigger points significantly reduced spontaneous electrical activity (SEA) in the treated muscle, indicating its effectiveness in relieving myofascial pain.

The results suggest that eliciting local twitch responses during dry needling is crucial for reducing SEA, highlighting that this response, rather than just the needling itself, plays a key role in the treatment's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibitory effect of dry needling on the spontaneous electrical activity recorded from myofascial trigger spots of rabbit skeletal muscle. Chen, JT., Chung, KC., Hou, CR., et al.[2019]

In a study involving 39 physiotherapists and 7629 treatments, trigger point dry needling (TrP-DN) was found to have a high incidence of mild adverse events (AEs), with 1463 reported cases, but no significant AEs occurred, indicating a very low risk of serious complications (≤ 0.04%).

Common mild AEs included bruising (7.55%) and bleeding (4.65%), but the overall safety profile suggests that TrP-DN is a safe treatment option for myofascial pain when performed by trained physiotherapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events following trigger point dry needling: a prospective survey of chartered physiotherapists. Brady, S., McEvoy, J., Dommerholt, J., et al.[2022]

Dry needling is generally safe and well tolerated for treating myofascial pain, but there is a risk of severe complications, such as an acute spinal epidural hematoma, as highlighted in this case report.

Healthcare providers should exercise caution when performing dry needling near the spine, and any sudden neuropathic pain following the procedure should be evaluated immediately with advanced imaging to ensure spinal cord integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Spinal Epidural Hematoma as a Complication of Dry Needling: A Case Report. Berrigan, WA., Whitehair, CL., Zorowitz, RD.[2020]

A case study of a 62-year-old male with chronic shoulder spasticity post-stroke showed significant improvement in spasticity and shoulder range of motion after 9 sessions of dry needling targeting specific muscle trigger points.

The results suggest that dry needling can be an effective treatment for alleviating chronic post-stroke shoulder spasticity, providing a non-drug intervention option for patients with similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dry needling at myofascial trigger points mitigates chronic post-stroke shoulder spasticity. Tang, L., Li, Y., Huang, QM., et al.[2020]

Dry needling (DN) significantly reduced wrist flexor spasticity in stroke patients, as evidenced by a decrease in Modified Modified Ashworth Scale (MMAS) scores from a median of 2 at baseline to 1 immediately after treatment and one hour later.

The study, involving 29 stroke patients, also showed improvements in other measures of muscle function and excitability, indicating that DN may effectively lower muscle stiffness and enhance movement shortly after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single group, pretest-posttest clinical trial for the effects of dry needling on wrist flexors spasticity after stroke. Fakhari, Z., Ansari, NN., Naghdi, S., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Is Dry Needling Effective for the Management of Spasticity, Pain, and Motor Function in Post-Stroke Patients? A Systematic Review and Meta-Analysis. [2021]

2. Scotland pubmed.ncbi.nlm.nih.gov

Dry needling for the management of spasticity, pain, and range of movement in adults after stroke: A systematic review. [2021]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Concurrent Effects of Dry Needling and Electrical Stimulation in the Management of Upper Extremity Hemiparesis. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Are There Trigger Points in the Spastic Muscles? Electromyographical Evidence of Dry Needling Effects on Spastic Finger Flexors in Chronic Stroke. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Post-needling soreness and trigger point dry needling for hemiplegic shoulder pain following stroke. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Inhibitory effect of dry needling on the spontaneous electrical activity recorded from myofascial trigger spots of rabbit skeletal muscle. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Adverse events following trigger point dry needling: a prospective survey of chartered physiotherapists. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Acute Spinal Epidural Hematoma as a Complication of Dry Needling: A Case Report. [2020]

9. India pubmed.ncbi.nlm.nih.gov

Dry needling at myofascial trigger points mitigates chronic post-stroke shoulder spasticity. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

A single group, pretest-posttest clinical trial for the effects of dry needling on wrist flexors spasticity after stroke. [2018]