This report covers a not yet recruiting trial at Oslo University Hospital evaluating spinal cord stimulation within a multidisciplinary treatment bundle for severe chronic neuropathic pain, as of February 11, 2026.
The listing describes a program that combines device based spinal cord stimulation with rehabilitation exercises and acceptance and commitment therapy as components of a treatment bundle. Sponsorship is provided by Oslo University Hospital and the trial status is not yet recruiting. The ClinicalTrials.gov identifier is NCT07403331 and the public record is available at the link below.
What is being studied?
The ClinicalTrials.gov listing describes a treatment bundle that includes spinal cord stimulation in combination with multidisciplinary care for severe chronic neuropathic pain. The intervention components listed include rehabilitation exercises and acceptance and commitment therapy as part of the bundle. Sponsorship is provided by Oslo University Hospital and the record notes the trial status as not yet recruiting. The public record identifier is NCT07403331 and the entry is accessible at the provided public link: https://clinicaltrials.gov/study/NCT07403331?term=medical+device.
The trial design emphasizes a bundle approach rather than a single intervention, with the aim of coordinating device therapy with rehabilitation and psychological strategies in a real world care pathway.
Study design and status
This listing indicates a bundle based approach rather than a single device. The status is not yet recruiting and the sponsor is Oslo University Hospital. The trial identifier is NCT07403331 and the official record can be viewed at https://clinicaltrials.gov/study/NCT07403331?term=medical+device. The record underscores the involvement of multidisciplinary care components that extend beyond the device itself.
Implications for patients and regulators
If enrollment proceeds, the bundle may be evaluated in the context of a combined modality approach. Regulators and device makers will expect clear statements of intended use, safety and performance data, and risk management following MDR Annex XIV guidelines. Stakeholders should monitor the official record for updates and any forthcoming results. Updates may influence patient pathways and indicate how such bundles could be implemented in clinical practice while ensuring regulatory compliance.
Safety and regulatory considerations
Spinal cord stimulation devices are subject to safety and performance standards under European and national rules. Any future results will need to address safety signals and efficacy within the applicable regulatory framework. The sponsor’s statements reflect the registry listing and do not guarantee outcomes. Full documentation would be provided in the final protocol and consent materials if enrollment begins. Practitioners should review MDR requirements and national guidance when considering inclusion of SCS in a bundle.
FAQ
- Q1: What is the focus of this trial?
A1: The trial centers on a treatment bundle that includes spinal cord stimulation as part of multidisciplinary care for severe chronic neuropathic pain, with not yet recruiting status. - Q2: Where is the trial hosted?
A2: Oslo University Hospital is listed as the sponsor. - Q3: What is the current status?
A3: The record states not yet recruiting. - Q4: Where can I find the official record?
A4: The public record is on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07403331?term=medical+device.
Conclusion
The listing indicates ongoing interest in integrating spinal cord stimulation within a multidisciplinary care bundle for neuropathic pain. Regulators and device developers should monitor updates from Oslo University Hospital and the ClinicalTrials.gov entry for changes in scope, safety plans, and potential results. Stakeholders should track enrollment milestones and any communications from the sponsor.
Disclaimer
This article is for professionals and is not legal advice. It is not a substitute for regulatory counsel or formal guidance from authorities. Do not rely on this content as regulatory advice.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07403331?term=medical+device