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

National Taiwan University

Status: Enrolling

Conditions: Stroke; Muscle Spasticity

Treatments: Device: focused extracorporeal shock wave therapy (ESWT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06674785

202409035RIND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Focused Extracorporeal Shock Wave

Experimental group

Description:

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.

Treatment:

Device: focused extracorporeal shock wave therapy (ESWT)

Device: focused extracorporeal shock wave therapy (ESWT)

Placebo-Controlled Shockwave Therapy

Placebo Comparator group

Description:

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.

Treatment:

Device: focused extracorporeal shock wave therapy (ESWT)

Device: focused extracorporeal shock wave therapy (ESWT)