A new clinical trial aims to investigate the immediate effects of therapeutic ultrasound on passive muscle stiffness and neck pain in affected patients. The study, currently listed as ‘not yet recruiting,’ is sponsored collaboratively by Erzurum Technical University, Ataturk University, Amasya University, and Bangor University.
What changed?
The launch of this clinical trial represents a key step in evaluating non-invasive devices for managing chronic neck pain and muscle stiffness. By analyzing both therapeutic and sham ultrasound applications, researchers aim to determine the measurable impact of these interventions. Healthcare providers and clinical researchers tracking advancements in therapeutic devices should note this study.
Clinical trial design
Study objectives
The research focuses on patients suffering from neck pain. The objective is to measure immediate changes in muscle stiffness and pain levels following either therapeutic or sham ultrasound intervention. These devices are regulated and fall under medical-grade equipment classifications. Performance, safety, and efficacy data from this trial may influence future device approvals.
Key methodologies
Participants will be assigned to either the therapeutic or sham ultrasound group. Devices supplying therapeutic ultrasound emit sound waves designed to target muscle tissue and reduce stiffness. Sham ultrasound devices mimic the therapy without producing active therapeutic mechanisms, serving as a control for comparison.
Sponsorship and collaboration
The study benefits from a multi-institutional effort involving universities in Turkey (Erzurum Technical University, Ataturk University, Amasya University) and the UK (Bangor University). Such collaborations ensure transparency and adherence to international clinical trial standards.
Who is affected?
Patients with ongoing neck pain and muscle stiffness stand to benefit from evidence-based therapeutic advancements. Clinicians specializing in musculoskeletal health may find insights from this trial valuable for integrating ultrasound therapy into their practice.
Regulatory bodies will monitor the trial outcomes to assess device performance and risk-benefit ratios under applicable medical device regulations. Manufacturers aiming for device authorization or certification may use the findings as benchmarks for product claims.
FAQs
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What is therapeutic ultrasound?
Therapeutic ultrasound uses sound waves to treat soft tissue injuries or musculoskeletal pain by stimulating healing or reducing stiffness.
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What is sham ultrasound?
Sham ultrasound is a placebo-controlled device used in trials to ensure unbiased comparisons without active therapeutic impact.
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Who sponsors this study?
The trial is jointly sponsored by Erzurum Technical University, Ataturk University, Amasya University, and Bangor University.
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What stage is this trial?
The trial is listed as ‘not yet recruiting,’ meaning enrollment has not begun.
Conclusion
This clinical trial introduces a significant opportunity to advance therapeutic ultrasound as a non-invasive solution for neck pain and muscle stiffness. Healthcare teams, regulators, and device developers should monitor its outcomes for potential implications in evidence-based care.
Disclaimer
This blog post is intended for informational purposes only and does not constitute legal or regulatory advice. Consult relevant professionals for compliance guidance.
Full announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07203040?term=medical+device