Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.
Moens Maarten
195 participants
Sep 29, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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
- years and older
- Speaking and reading Dutch or French
Exclusion Criteria6
- 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.
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Interventions
Usual care with respect to Spinal Cord Stimulation implantation
A standardized pain medication tapering program before Spinal Cord Stimulator implantation.
A personalized pain medication tapering program before Spinal Cord Stimulator implantation.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT05861609