MTI University has announced plans for a clinical trial investigating the effectiveness of two device-based therapies for patients suffering from shoulder-related complications following a stroke. The trial, titled “Shockwave and Cryoflow for Shoulder Pain After Stroke,” aims to explore how Extracorporeal Shockwave Therapy (ESWT), Cryoflow Therapy, and traditional physical therapy techniques compare in addressing post-stroke shoulder pain, rotator cuff tendonitis, and shoulder spasticity. At the time of writing, the study is not yet recruiting participants.
What conditions are being addressed?
The study focuses on three prominent conditions often experienced by individuals recovering from a stroke:
- Post-stroke shoulder pain: Persistent discomfort and reduced mobility in the shoulder region, frequently caused by nerve damage and muscular complications after a stroke.
- Rotator cuff tendonitis: Inflammation or irritation of the rotator cuff tendons, which can contribute to pain and restrict shoulder movement.
- Shoulder spasticity: Muscular stiffness and spasms that impair joint function, often stemming from neurological impacts of stroke.
These conditions can significantly affect a patient’s quality of life and functional independence, making targeted therapeutic approaches vital for recovery.
What interventions are being tested?
The clinical trial will evaluate the following interventions:
- Extracorporeal Shockwave Therapy (ESWT): A non-invasive device that uses sound waves to stimulate healing in musculoskeletal tissue.
- Cryoflow Therapy: A device applying localized cooling to reduce inflammation, decrease sensitivity to pain, and improve muscular relaxation.
- Traditional Physical Therapy Program: A behavioral intervention that utilizes standardized exercises to rehabilitate and strengthen the shoulder.
- Placebo ESWT and Cryoflow: A control intervention providing simulated experiences without active therapeutic effects.
The trial seeks to determine which approach—or combination of approaches—delivers the best patient outcomes in terms of pain reduction, mobility improvement, and safety.
How will the study be conducted?
MTI University, the sponsor for this trial, has outlined a comprehensive study protocol designed to ensure reliable data collection and analysis:
- Participant criteria: The study will recruit individuals diagnosed with one or more of the targeted shoulder conditions as a direct aftermath of a stroke.
- Evaluation method: Researchers will monitor participants’ progress using standardized pain scales, mobility assessments, and patient-reported outcomes.
- Control mechanisms: The placebo arms will allow comparison against active therapeutic interventions to validate effectiveness.
The study is listed on ClinicalTrials.gov under ID number NCT07196267 and is expected to begin recruitment soon.
FAQ
1. When does recruitment for the study begin?
The study is currently labeled as “Not yet recruiting.” Interested parties should monitor the updates on ClinicalTrials.gov.
2. Are the devices FDA-approved?
Each device complies with applicable regulatory standards and is being tested for performance and safety in this trial. For full regulatory status, consult the study sponsors.
3. Can these therapies be combined with existing treatments?
The study will evaluate standalone and placebo-controlled approaches, but further clinical discussions are needed to explore combined therapeutic usage.
Conclusion
This upcoming trial represents a pivotal exploration of device-based therapies for addressing complex shoulder conditions in post-stroke patients. By comparing innovative interventions such as ESWT and Cryoflow Therapy with traditional approaches, MTI University aims to determine optimal treatment pathways that balance efficacy and safety.
Disclaimer
The information provided in this article is intended for clinical, quality, and regulatory professionals and is not legal advice. Readers should consult appropriate experts for specific applications.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07196267?term=medical+device