StrokeNCT06674785
SIRS-ESWT Trial: Shoulder Internal Rotator Spasticity Trial Treated With Extracorporeal Shock Wave Therapy Trial
A study testing focused extracorporeal shock wave therapy (ESWT) in people with Stroke and Muscle Spasticity, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Extracorporeal shock wave therapy (ESWT) has shown potential in reducing post-stroke limb spasticity. This study aims to evaluate the efficacy of focused ESWT on shoulder internal rotator spasticity in post-stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Muscle Spasticity
- What is being tested?
- focused extracorporeal shock wave therapy (ESWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Jul 2025to 31 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older with unilateral cerebral stroke.
- Restricted passive external rotation of the spastic shoulder by more than 20 degrees.
- A Modified Ashworth Scale score of 1 or higher for shoulder internal rotator spasticity.
- Stable medical condition and vital signs.
- Clear consciousness, able to follow instructions.
Who cannot join
- History of two or more strokes, traumatic brain injury, brain tumors, or other cerebral disorders.
- Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal conditions affecting muscle tone assessment.
- Ineligibility for shock wave intervention due to malignancies, coagulation disorders, localized infections, or presence of a pacemaker.
- Prior shock wave intervention or botulinum toxin injection for post-stroke spasticity within the past three months.
- Inability to participate in interventions or functional assessments due to cognitive, consciousness, or language impairments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital
Taipei
Shu-mei Yang, MD, 0972653675, b99401109@gmail.com
About this study
Official title: Effects of Extracorporeal Shock Wave Therapy on Shoulder Internal Rotator Spasticity in Post-Stroke Patients: A Randomized Controlled Trial
Extracorporeal shock wave therapy (ESWT) has shown potential in reducing post-stroke limb spasticity. This study aims to evaluate the efficacy of focused ESWT on shoulder internal rotator spasticity in post-stroke patients.
Read the detailed description
This study aimed to evaluate the effects of focused extracorporeal shock wave therapy (ESWT) on shoulder internal rotator spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific shoulder internal rotators, and a control group receiving placebo treatments mimicking the shockwave therapy, with treatments administered twice weekly over two weeks for a total of four sessions.
The efficacy of the treatment was measured using a comprehensive set of assessment tools, including range of motion, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, and ultrasound strain elastography. The outcomes were evaluated at multiple points in time: before treatment, and 1, 4, 12, and 24 weeks after the therapy concluded, to assess both immediate and sustained effects of the treatment on shoulder function and spasticity in stroke survivors.
- Conditions
- Stroke, Muscle Spasticity
- Being tested
- focused extracorporeal shock wave therapy (ESWT)
- Keywords
- stroke, spasticity, shock wave, shoulder
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focused extracorporeal shock wave therapy (ESWT)Device
The focused shockwaves are directed at the affected muscles in the upper limb, specifically targeting the subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.
focused extracorporeal shock wave therapy (ESWT)Device
Placebo shockwave therapy directed at subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.
| Study group | Role | What they receive |
|---|---|---|
| Focused Extracorporeal Shock Wave | Experimental | Participants in this arm will receive focused Extracorporeal Shock Wave Therapy (ESWT) targeting four specific muscles: subscapularis, pectoralis major, latissimus dorsi, and teres major muscles. Each muscle will receive 1,000 shockwave shots per session, accumulating to a total of 4,000 shots across all targeted muscles in each session. The treatment will be administered twice a week for two consecutive weeks, resulting in a total of four treatment sessions. Receives: Device: focused extracorporeal shock wave therapy (ESWT) |
| Placebo-Controlled Shockwave Therapy | Placebo comparator | Participants in this arm will receive placebo-controlled focused ESWT, mirroring the treatment protocol of the experimental group but without the application of active shockwaves. Receives: Device: focused extracorporeal shock wave therapy (ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
passive range of motion for the shoulder joints
the extent to which a joint can be moved without the patient actively participating in the movement
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
shoulder strength
the muscle power generated by the shoulder muscles, quantified using the Medical Research Council (MRC) scale, which grades muscle strength from 0 (no visible contraction) to 5 (normal strength against full resistance)
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Visual Analogue Scale (VAS)
individuals rate their pain from 0 to 10, where 0 represents 'no pain' and 10 signifies 'the worst pain imaginable
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
modified Ashworth scale (MAS)
Evaluate spasticity in individuals with neurological conditions. The scale ranges from 0, indicating no increase in muscle tone, to 4, which represents severe spasticity with affected parts rigid in flexion or extension.
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Secondary outcomes (5)
Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)
range from 0 (complete paralysis) to 66 (full function), assessing motor recovery in post-stroke upper extremities
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Action Research Arm Test (ARAT)
a standardized measure evaluating upper limb motor ability in stroke patients, scoring from 0 (no movement) to 57 (normal arm function). It assesses grasp, grip, pinch, and gross arm movement.
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Barthel index
measures a person's daily living abilities, focusing on ten areas of self-care and mobility. Scores range from 0 to 100, with higher scores denoting greater independence.
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Wolf Motor Function Test
assess upper extremity function in individuals with neurological impairments, using 17 tasks divided into sections of time, functional ability, and strength. Scoring is on a 6-point ordinal scale, ranging from 0 ("Does not attempt with upper extremity being tested," indicating severe impairment) to 5 ("Movement appears to be normal," suggesting full functionality). Lower scores indicate greater impairment.
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
ultrasound assessment
used strain elastography to assess elasticity of shoulder muscles
Measured: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start23 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-mei Yang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674785
- Sponsor's protocol ID
- 202409035RIND
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haghighat S, Khosravi M, Saadatnia M, Hashemijaazi M. Effect of Extracorporeal Shockwave Therapy on Pain Management of Patients with Post-Stroke Hemiplegic Shoulder Pain: A Prospective Randomized Controlled Trial. Adv Biomed Res. 2023 Aug 31;12:216. doi: 10.4103/abr.abr_279_21. eCollection 2023.
PubMed 38073721Wu YT, Chang CN, Chen YM, Hu GC. Comparison of the effect of focused and radial extracorporeal shock waves on spastic equinus in patients with stroke: a randomized controlled trial. Eur J Phys Rehabil Med. 2018 Aug;54(4):518-525. doi: 10.23736/S1973-9087.17.04801-8. Epub 2017 Oct 25.
PubMed 29072044Yoon SH, Shin MK, Choi EJ, Kang HJ. Effective Site for the Application of Extracorporeal Shock-Wave Therapy on Spasticity in Chronic Stroke: Muscle Belly or Myotendinous Junction. Ann Rehabil Med. 2017 Aug;41(4):547-555. doi: 10.5535/arm.2017.41.4.547. Epub 2017 Aug 31.
PubMed 28971038Li G, Yuan W, Liu G, Qiao L, Zhang Y, Wang Y, Wang W, Zhao M, Wang Y, Wang J. Effects of radial extracorporeal shockwave therapy on spasticity of upper-limb agonist/antagonist muscles in patients affected by stroke: a randomized, single-blind clinical trial. Age Ageing. 2020 Feb 27;49(2):246-252. doi: 10.1093/ageing/afz159.
PubMed 31846499
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Extracorporeal Shock Wave Therapy on Shoulder Internal Rotator Spasticity in Post-Stroke Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06674785
- Acronym / sponsor ID
- 202409035RIND
- Conditions
- Stroke, Muscle Spasticity
- Keywords
- stroke, spasticity, shock wave, shoulder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 23 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Nov 2024 (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.
Extracorporeal shock wave therapy (ESWT) has shown potential in reducing post-stroke limb spasticity. This study aims to evaluate the efficacy of focused ESWT on shoulder internal rotator spasticity in post-stroke patients.
Detailed description
This study aimed to evaluate the effects of focused extracorporeal shock wave therapy (ESWT) on shoulder internal rotator spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific shoulder internal rotators, and a control group receiving placebo treatments mimicking the shockwave therapy, with treatments administered twice weekly over two weeks for a total of four sessions.
The efficacy of the treatment was measured using a comprehensive set of assessment tools, including range of motion, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, and ultrasound strain elastography. The outcomes were evaluated at multiple points in time: before treatment, and 1, 4, 12, and 24 weeks after the therapy concluded, to assess both immediate and sustained effects of the treatment on shoulder function and spasticity in stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focused Extracorporeal Shock Wave | Experimental | Device: focused extracorporeal shock wave therapy (ESWT)Participants in this arm will receive focused Extracorporeal Shock Wave Therapy (ESWT) targeting four specific muscles: subscapularis, pectoralis major, latissimus dorsi, and teres major muscles. Each muscle will receive 1,000 shockwave shots per session, accumulating to a total of 4,000 shots across all targeted muscles in each session. The treatment will be administered twice a week for two consecutive weeks, resulting in a total of four treatment sessions. |
| Placebo-Controlled Shockwave Therapy | Placebo comparator | Device: focused extracorporeal shock wave therapy (ESWT)Participants in this arm will receive placebo-controlled focused ESWT, mirroring the treatment protocol of the experimental group but without the application of active shockwaves. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years or older with unilateral cerebral stroke.
- Restricted passive external rotation of the spastic shoulder by more than 20 degrees.
- A Modified Ashworth Scale score of 1 or higher for shoulder internal rotator spasticity.
- Stable medical condition and vital signs.
- Clear consciousness, able to follow instructions.
Key exclusion criteria (5 listed)
- History of two or more strokes, traumatic brain injury, brain tumors, or other cerebral disorders.
- Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal conditions affecting muscle tone assessment.
- Ineligibility for shock wave intervention due to malignancies, coagulation disorders, localized infections, or presence of a pacemaker.
- Prior shock wave intervention or botulinum toxin injection for post-stroke spasticity within the past three months.
- Inability to participate in interventions or functional assessments due to cognitive, consciousness, or language impairments.
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 |
|---|---|---|
| focused extracorporeal shock wave therapy (ESWT)The focused shockwaves are directed at the affected muscles in the upper limb, specifically targeting the subscapularis, pectoralis major, latissimus dorsi, and teres major muscles. | Device | Focused Extracorporeal Shock Wave |
| focused extracorporeal shock wave therapy (ESWT)Placebo shockwave therapy directed at subscapularis, pectoralis major, latissimus dorsi, and teres major muscles. | Device | Placebo-Controlled Shockwave Therapy |
Primary outcome
passive range of motion for the shoulder joints
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
the extent to which a joint can be moved without the patient actively participating in the movement
shoulder strength
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
the muscle power generated by the shoulder muscles, quantified using the Medical Research Council (MRC) scale, which grades muscle strength from 0 (no visible contraction) to 5 (normal strength against full resistance)
Visual Analogue Scale (VAS)
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
individuals rate their pain from 0 to 10, where 0 represents 'no pain' and 10 signifies 'the worst pain imaginable
modified Ashworth scale (MAS)
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Evaluate spasticity in individuals with neurological conditions. The scale ranges from 0, indicating no increase in muscle tone, to 4, which represents severe spasticity with affected parts rigid in flexion or extension.
5 secondary outcomes
Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Action Research Arm Test (ARAT)
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Barthel index
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Wolf Motor Function Test
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
ultrasound assessment
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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 29 Jul 2025.
- Background: PubMed 38073721Haghighat S, Khosravi M, Saadatnia M, Hashemijaazi M. Effect of Extracorporeal Shockwave Therapy on Pain Management of Patients with Post-Stroke Hemiplegic Shoulder Pain: A Prospective Randomized Controlled Trial. Adv Biomed Res. 2023 Aug 31;12:216. doi: 10.4103/abr.abr_279_21. eCollection 2023.
- Background: PubMed 29072044Wu YT, Chang CN, Chen YM, Hu GC. Comparison of the effect of focused and radial extracorporeal shock waves on spastic equinus in patients with stroke: a randomized controlled trial. Eur J Phys Rehabil Med. 2018 Aug;54(4):518-525. doi: 10.23736/S1973-9087.17.04801-8. Epub 2017 Oct 25.
- Background: PubMed 28971038Yoon SH, Shin MK, Choi EJ, Kang HJ. Effective Site for the Application of Extracorporeal Shock-Wave Therapy on Spasticity in Chronic Stroke: Muscle Belly or Myotendinous Junction. Ann Rehabil Med. 2017 Aug;41(4):547-555. doi: 10.5535/arm.2017.41.4.547. Epub 2017 Aug 31.
- Background: PubMed 31846499Li G, Yuan W, Liu G, Qiao L, Zhang Y, Wang Y, Wang W, Zhao M, Wang Y, Wang J. Effects of radial extracorporeal shockwave therapy on spasticity of upper-limb agonist/antagonist muscles in patients affected by stroke: a randomized, single-blind clinical trial. Age Ageing. 2020 Feb 27;49(2):246-252. doi: 10.1093/ageing/afz159.
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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.
Shu-mei Yang, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing focused extracorporeal shock wave therapy (ESWT) in people with Stroke and Muscle Spasticity, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Jul 2025. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Contact Shu-mei Yang, MD (0972653675, b99401109@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
passive range of motion for the shoulder joints (time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06674785, which also lists 4 linked publications.
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 29 Jul 2025.