Clinical Trial

Pain Medication Tapering for Patients With Persistent Spinal Pain Syndrome Type 2, Treated With Spinal Cord Stimulation.

Study acronym: PIANISSIMO
Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-05-06.
Status change: Not Yet Recruiting → Recruiting 2023-10-17
Trial Details
NCT Number NCT05861609
Lead Sponsor Moens Maarten
Collaborators: Vrije Universiteit Brussel
Conditions Persistent Spinal Pain Syndrome Type 2, Spinal Cord Stimulation
Enrollment 195 participants
Start Date 2023-09-29
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2023-10-18