The discontinuation of pain medication in patients with failed back surgery, treated with spinal cord stimulation.
- Conditions
- Persistent spinal pain syndrome type 2Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2022-003925-23-BE
- Lead Sponsor
- Vrije Universiteit Brussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 195
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method