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NCT Number: NCT06674785

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital

Taipei, Taiwan

Location status: Recruiting

Location contact

Shu-mei Yang, MD

CONTACT

[email protected]

0972653675

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. ultrasound assessment

    Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment

    used strain elastography to assess elasticity of shoulder muscles

Study contacts

Contact information is provided by the study sponsor or research team.

Shu-mei Yang, MD

CONTACT

[email protected]

0972653675

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Effects of Extracorporeal Shock Wave Therapy on Shoulder Internal Rotator Spasticity in Post-Stroke Patients: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 5, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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