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

NCT06674785 | Recruiting

• 1 other identifier: 202409035RIND
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Muscle Spasticity

Keywords

stroke; spasticity; shock wave; shoulder

Outcome Measures

Primary Outcomes (4)

• 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

  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)

  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

  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.

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

Secondary Outcomes (5)

• Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)

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

• Action Research Arm Test (ARAT)

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

• Barthel index

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

• Wolf Motor Function Test

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

• ultrasound assessment

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

Study Arms (2)

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.

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.

Device: focused extracorporeal shock wave therapy (ESWT)

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (4)

• 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.

  PMID: 38073721 BACKGROUND

• Wu 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.

  PMID: 29072044 BACKGROUND

• Yoon 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.

  PMID: 28971038 BACKGROUND

• Li 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.

  PMID: 31846499 BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Shu-mei Yang, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-mei Yang, MD

CONTACT

0972653675; b99401109@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant Care Provider Outcomes Assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 5, 2024
• Study Start: July 23, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 29, 2025

Record last verified: 2024-10

Locations

TW (1)