Pain medication tapering for patients with Persistent Spinal PainSyndrome Type II, treated with Spinal Cord Stimulation. - PIANISSIMO

Vrije Universiteit Brussel0 个研究点目标入组 195 人开始时间: 2023年1月17日最近更新: 2024年8月12日

适应症

试验速览

暂无简介。

•- Patients being diagnosed with persistent spinal cord stimulation type 2, 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 156
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 39

•- Being actively treated for cancer,
•- Having a life expectancy below 6 months,
•- Receiving intrathecal drug delivery,
•- Having contraindications for Clonidine (e.g., known hypotension which requires medication) or for Buprenorphine/Naloxone (e.g., severe respiratory insufficiency, hepatic insufficiency)
•- Having epilepsy currently treated by Pregabalin,
•- Currently using benzodiazepines at doses more than 40 mg diazepam-equivalents per day.

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