Actively Recruiting
Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.
Led by Moens Maarten · Updated on 2023-10-18
195
Participants Needed
3
Research Sites
152 weeks
Total Duration
On this page
Sponsors
M
Moens Maarten
Lead Sponsor
V
Vrije Universiteit Brussel
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with Persistent Spinal Pain Syndrome Type 2, experiencing neuropathic pain in the lower back and/or legs with a pain intensity of at least 4 out of 10
- Pain lasting at least 6 months after at least one successful spinal surgery
- Pain not responding to conservative treatment
- Scheduled for Spinal Cord Stimulation implantation
- Currently taking opioids
- Aged 18 years or older
- Able to speak and read Dutch or French
You will not qualify if you...
- Actively being treated for cancer
- Life expectancy less than 6 months
- Receiving intrathecal drug delivery
- Contraindications for Clonidine (such as known hypotension requiring medication)
- Contraindications for Buprenorphine/Naloxone (such as severe respiratory or liver insufficiency)
- Epilepsy treated with Pregabalin
- Using benzodiazepines at doses higher than 40 mg diazepam-equivalents daily
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Universitair Ziekenhuis Brussel
Jette, Belgium, 1090
Actively Recruiting
2
Heilig Hart Ziekenhuis Lier
Lier, Belgium, 2500
Not Yet Recruiting
3
AZ Delta
Roeselare, Belgium, 8800
Actively Recruiting
Research Team
M
Maarten Moens, Prof, Dr.
CONTACT
L
Lisa Goudman, Prof, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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