Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation. (PIANISSIMO)
Persistent Spinal Pain Syndrome Type 2, Spinal Cord Stimulation
About this trial
This is an interventional treatment trial for Persistent Spinal Pain Syndrome Type 2
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.
Sites / Locations
- Universitair Ziekenhuis BrusselRecruiting
- Heilig Hart Ziekenhuis Lier
- AZ DeltaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
No pain medication tapering (usual care)
Standardized pain medication tapering
Personalized pain medication tapering
Usual care
Standardized pain medication tapering
Personalized pain medication tapering