The latest clinical study explores the acute effects of Transcutaneous Electrical Nerve Stimulation (TENS) on cervical muscle stiffness and pain management in patients with neck pain. This research could shape new approaches to treating chronic neck conditions with medical devices. The study is enrolling participants by invitation.
What changed?
The study investigates advancements in the application of TENS devices for neck pain, particularly in reducing muscle stiffness—a prevalent symptom in chronic neck conditions. Supported by multiple institutions, including Erzurum Technical University and Bangor University, this trial targets improvements in therapeutic outcomes using electrical nerve stimulation technology.
Study details
The trial aims to measure and compare acute changes in cervical muscle stiffness and pain relief between active TENS devices and sham TENS placebo devices. Participants will undergo controlled sessions, with outcomes analyzed through scientific protocols.
Primary sponsors
The study is backed by Erzurum Technical University, Amasya University, Bangor University, and Ataturk University. These institutions play key roles in design, execution, and analysis for regulatory-compliant outcomes.
Enrollment type
This trial is recruiting participants through direct invitation to ensure carefully selected candidates meet the study requirements.
Clinical implications
TENS devices are widely recognized for their pain mitigation capabilities. By systematically assessing their effect on muscle stiffness, this trial could further define the regulatory pathways for these devices. If proven effective, healthcare professionals might gain newer insights on treatment alignment under standardized care guidelines.
Patient impact
Millions of patients worldwide suffer from chronic neck pain. A validated method addressing both pain and stiffness would directly influence physical therapy programs and device recommendations.
Future regulatory frameworks
The outcomes may assist regulatory authorities in refining parameters for evaluating medical devices designed for pain management. As safety and performance remain critical under MDR standards, devices like TENS could benefit from clearer classification and labeling practices.
FAQ
- What is TENS?
TENS (Transcutaneous Electrical Nerve Stimulation) is a non-invasive device delivering electrical impulses for pain relief. - Who can participate?
Participants are invited based on medical criteria assessed by the sponsoring institutions. - Why is muscle stiffness important?
Stiffness reduces mobility and amplifies pain symptoms, influencing quality of life. - Are controls included?
Yes, sham devices ensure reliable comparisons to eliminate biases.
Conclusion
The study provides a significant opportunity to assess safe, innovative treatments for chronic neck pain. Enrollment is ongoing, and outcomes could influence both clinical practices and regulatory standards for TENS devices.
Disclaimer
This article is intended for healthcare and regulatory professionals. It does not constitute legal advice. For specific guidance, consult a qualified expert.
Announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07244861?term=medical+device