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The discontinuation of pain medication in patients with failed back surgery, treated with spinal cord stimulation.

Phase 1
Conditions
Persistent spinal pain syndrome type 2
Therapeutic 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
Inclusion Criteria

- 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

Exclusion Criteria

- 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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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