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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-23

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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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

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Stroke Muscle Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participant Care Provider Outcomes Assessor

Study Groups

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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.

Group Type EXPERIMENTAL

focused extracorporeal shock wave therapy (ESWT)

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

focused extracorporeal shock wave therapy (ESWT)

Intervention Type DEVICE

Placebo shockwave therapy directed at subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.

Interventions

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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.

Intervention Type DEVICE

focused extracorporeal shock wave therapy (ESWT)

Placebo shockwave therapy directed at subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No