A groundbreaking clinical trial is set to investigate the comparative effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Percutaneous Electrical Nerve Stimulation (PENS) on radial nerve activation. Sponsored by the University of Castilla-La Mancha, the study will focus on evaluating pain modulation and sensorimotor functionality through advanced nerve stimulation methodologies. Healthcare professionals and regulatory experts will closely monitor these developments as recruitment for the study nears.
In this article:
- What changed?
- Clinical trial details
- Key objectives of the study
- Who is affected?
- FAQ
- Conclusion
- Disclaimer
- Announcement link
What changed?
The upcoming trial appears on ClinicalTrials.gov and focuses on innovative uses of TENS and PENS techniques for radial nerve stimulation. The University of Castilla-La Mancha, the trial sponsor, has announced that recruitment for the study has not yet begun. This announcement marks a significant step towards advancing the understanding of nerve stimulation technologies for pain modulation and sensorimotor enhancements.
Clinical trial details
The trial aims to compare safety and performance outcomes for four intervention groups. These include TENS devices, PENS devices, sham TENS, and sham PENS interventions. Investigators will evaluate how different methods affect pain response and sensorimotor functionality, potentially setting new benchmarks for these established nerve modulation technologies.
The trial will target individuals experiencing pain and related sensorimotor issues, though further inclusion criteria have yet to be disclosed. These findings could offer valuable clinical insights and influence regulatory pathways for nerve stimulation devices.
Key objectives of the study
The primary goal of this trial is to assess the efficacy of transcutaneous and percutaneous approaches to radial nerve stimulation. Secondary measures include safety evaluations, patient-reported outcomes, and potential advances in pain therapies.
The inclusion of sham groups ensures scientific rigor, enabling researchers to differentiate the genuine therapeutic impact of these interventions from placebo effects. Outcomes may provide evidence to shape clinical best practices and inform medical device regulations.
Who is affected?
This study is particularly relevant for clinical researchers, medical device manufacturers, and regulators focused on pain management therapies. Professionals working in pain modulation technology development may also benefit from tracking the trial’s progress.
In addition, healthcare providers and patients could see implications for more effective non-pharmacological interventions targeting pain and rehabilitation, especially involving radial nerve-related conditions.
FAQ
- 1. What conditions are being studied?
The trial focuses on pain modulation and sensorimotor function improvements through radial nerve stimulation. - 2. What devices are being tested?
TENS, PENS, sham TENS, and sham PENS devices will be examined for efficacy and safety. - 3. Is this trial currently recruiting?
No, recruitment for this study has not yet begun. - 4. Who is conducting the trial?
The trial is sponsored by the University of Castilla-La Mancha. - 5. Where can more details be found?
Complete information is available on ClinicalTrials.gov.
Conclusion
This upcoming trial represents a critical opportunity to evaluate comparative methods in radial nerve stimulation. The findings could influence pain management strategies, sensorimotor therapies, and future regulatory considerations. Stakeholders from clinical and regulatory domains should watch for updates.
Disclaimer
This article provides information for healthcare professionals and stakeholders. It is not intended as legal or clinical advice.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07247721?term=medical+device