Treatment of shoulder spasticity in stroke patients using shock wave therapy
Effects of Extracorporeal Shock Wave Therapy on Shoulder Internal Rotator Spasticity in Post-Stroke Patients: A Randomized Controlled Trial
NA · National Taiwan University Hospital · NCT06674785
This study is testing if shock wave therapy can help stroke patients with tight shoulder muscles feel better and move their arms more easily.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital (other) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06674785 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of focused extracorporeal shock wave therapy (ESWT) on shoulder internal rotator spasticity in patients who have suffered a stroke. Participants are randomly assigned to receive either the actual ESWT treatment or a placebo treatment that mimics the therapy. The treatment is administered twice weekly over two weeks, totaling four sessions, and various assessments are conducted to measure outcomes such as range of motion, pain levels, and functional abilities. The study aims to determine both the immediate and long-term effects of the therapy on shoulder function and spasticity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a unilateral cerebral stroke and exhibit significant shoulder internal rotator spasticity.
Not a fit: Patients with a history of multiple strokes, other central nervous system disorders, or those who have recently received similar treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve shoulder function and reduce spasticity in stroke survivors, enhancing their quality of life.
How similar studies have performed: Previous studies have shown promise for extracorporeal shock wave therapy in reducing spasticity, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Taipei
- Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)
Study contacts
- Principal investigator: Shu-mei Yang, MD — National Taiwan University Hospital
- Study coordinator: Shu-mei Yang, MD
- Email: b99401109@gmail.com
- Phone: 0972653675
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Muscle Spasticity, stroke, spasticity, shock wave, shoulder