NCT05861609 Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.
| NCT ID | NCT05861609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Moens Maarten |
| Condition | Persistent Spinal Pain Syndrome Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 195 participants |
| Start Date | 2023-09-29 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 195 participants in total. It began in 2023-09-29 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of the study is to examine whether there is a difference in disability after 12 months of Spinal Cord Stimulation (SCS) in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS T2) after receiving a standardized pain medication tapering protocol before SCS implantation, a personalized pain medication tapering protocol before SCS implantation, or no tapering protocol before SCS implantation. The secondary objective of the study is to examine whether there is a difference after 12 months of SCS in PSPS T2 patients after receiving a standardized pain medication tapering protocol before SCS implantation, a personalized pain medication tapering protocol before SCS implantation, or no tapering protocol before SCS implantation on pain intensity, health-related quality of life, participation, domains affected by substance use, anxiety and depression, medication use, psychological constructs, sleep, central sensitization, and healthcare expenditure.
Eligibility Criteria
Inclusion Criteria: * Patients with PSPS T2, defined as patients suffering from neuropathic pain of radicular origin with pain in the lower back and/or leg(s), of an intensity of at least 4/10 on the Numeric Rating Scale, for a period of at least 6 months after a minimum of one anatomically successful spinal surgery and being refractory to conservative treatment (according to Belgian reimbursement rules from January 1st, 2018) * Patients need to be scheduled for SCS to be eligible for participation in the study * Currently taking opioids * 18 years and older * Speaking and reading Dutch or French Exclusion Criteria: * Being actively treated for cancer. * Having a life expectancy below 6 months. * Receiving intrathecal drug delivery. * Patients with contraindications for Clonidine (e.g., known hypotension which requires medication) or for Buprenorphine/Naloxone (e.g., severe respiratory insufficiency, hepatic insufficiency). * Epilepsy treated by Pregabalin. * Currently using benzodiazepines at more than 40 mg diazepam-equivalents per day.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05861609 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Persistent Spinal Pain Syndrome Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05861609 currently recruiting?
Yes, NCT05861609 is actively recruiting participants. Contact the research team at stimulusresearchgroup@gmail.com for enrollment information.
Where is the NCT05861609 trial being conducted?
This trial is being conducted at Jette, Belgium, Lier, Belgium, Roeselare, Belgium.
Who is sponsoring the NCT05861609 clinical trial?
NCT05861609 is sponsored by Moens Maarten. The trial plans to enroll 195 participants.