Actively Recruiting
Led by Moens Maarten · Updated on 2023-10-18
195
Participants Needed
3
Research Sites
N/A
Total Duration
M
Moens Maarten
Lead Sponsor
V
Vrije Universiteit Brussel
Collaborating Sponsor
This research aims to compare the effects of different pain medication tapering approaches before Spinal Cord Stimulation (SCS) implantation in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS T2), a condition causing ongoing low back and leg pain after spinal surgery. The study evaluates whether standardized tapering, personalized tapering, or no tapering affects disability and other health outcomes over 12 months. Researchers are interested in how these approaches influence pain intensity, quality of life, medication use, psychological health, sleep, and healthcare costs. Participants are randomly assigned to one of three groups: usual care without tapering, a standardized pain medication tapering program before SCS implantation, or a personalized tapering program tailored to the patient. Pain medication tapering occurs during a hospital stay prior to the SCS implant. The study involves 195 patients, with 130 receiving tapering protocols and 65 receiving usual care. The trial uses a double-blind design to compare these approaches over one year. Throughout the study, participants are evaluated at baseline and at 1, 3, 6, and 12 months after receiving SCS. Assessments include disability scores as the primary outcome and various secondary measures such as pain intensity, health-related quality of life, participation in daily activities, substance use effects, anxiety and depression levels, medication use, psychological factors, sleep quality, central sensitization symptoms, and healthcare use. This comprehensive monitoring helps determine the impact of tapering strategies on overall patient well-being and resource use.
CONDITIONS
Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During a hospital stay prior to Spinal Cord Stimulation implantation
Participants undergo either a standardized or personalized pain medication tapering program before Spinal Cord Stimulation implantation, or receive usual care with no tapering.
Hospital stay visits depending on tapering program assignment
Duration - 12 months
Participants receive Spinal Cord Stimulation implantation and begin treatment for persistent spinal pain.
Visits at baseline, and 1 month, 3 months, 6 months, and 12 months after implantation
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
M
Maarten Moens, Prof, Dr.
L
Lisa Goudman, Prof, Dr.
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Maarten Moens, Cleo Lina Crunelle, Koen Putman...
https://pubmed.ncbi.nlm.nih.gov/39133680