Pain medication tapering for patients with persistent spinal pain treated with spinal cord stimulation
Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.
NA · Universitair Ziekenhuis Brussel · NCT05861609
This study is testing different ways to reduce pain medication for people with persistent spinal pain who are getting spinal cord stimulation to see which method helps them feel better and improve their daily life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 195 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel (other) |
| Locations | 3 sites (Jette and 2 other locations) |
| Trial ID | NCT05861609 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of different pain medication tapering protocols on disability in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS T2) who are undergoing Spinal Cord Stimulation (SCS). Participants will be randomly assigned to one of three groups: a standardized tapering protocol, a personalized tapering protocol, or no tapering protocol before SCS implantation. The study aims to assess changes in disability, pain intensity, quality of life, and other psychological and health-related factors over a 12-month period. By evaluating these approaches, the trial seeks to optimize pain management strategies for patients with chronic pain conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with PSPS T2 who are currently taking opioids and scheduled for SCS.
Not a fit: Patients actively treated for cancer or with a life expectancy of less than 6 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and reduced disability for patients with persistent spinal pain.
How similar studies have performed: While the approach of tapering pain medication before SCS is innovative, similar studies have shown varying degrees of success in managing chronic pain conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jette and 2 other locations
- Universitair Ziekenhuis Brussel — Jette, Belgium (RECRUITING)
- Heilig Hart Ziekenhuis Lier — Lier, Belgium (NOT_YET_RECRUITING)
- AZ Delta — Roeselare, Belgium (RECRUITING)
Study contacts
- Study coordinator: Maarten Moens, Prof, Dr.
- Email: stimulusresearchgroup@gmail.com
- Phone: +3224775514
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Persistent Spinal Pain Syndrome Type 2, Spinal Cord Stimulation