SIRS-ESWT Trial: Shoulder Internal Rotator Spasticity Trial Treated With Extracorporeal Shock Wave Therapy Trial

July 27, 2025 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo-Controlled Shockwave Therapy
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.
Device: 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 therapy (ESWT)
Placebo shockwave therapy directed at subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.
Experimental: Focused Extracorporeal Shock Wave
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.
Device: 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 therapy (ESWT)
Placebo shockwave therapy directed at subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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.
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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)
pre-treatment; 1, 4, 12, and 24 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)
Time Frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
range from 0 (complete paralysis) to 66 (full function), assessing motor recovery in post-stroke upper extremities
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
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.
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Barthel index
Time Frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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.
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
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.
pre-treatment; 1, 4, 12, and 24 weeks post-treatment
ultrasound assessment
Time Frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
used strain elastography to assess elasticity of shoulder muscles
pre-treatment; 1, 4, 12, and 24 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Shu-mei Yang, MD, National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

November 3, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 27, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202409035RIND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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