Actively Recruiting
Pain Medication Tapering Before Spinal Cord Stimulation for Persistent Spinal Pain Syndrome Type 2
Led by Moens Maarten · Updated on 2023-10-18
195
Participants Needed
3
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
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
Brief Title
Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.
Research Team
M
Maarten Moens, Prof, Dr.
L
Lisa Goudman, Prof, Dr.
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