RecruitingNot ApplicableNCT05861609

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


Sponsor

Moens Maarten

Enrollment

195 participants

Start Date

Sep 29, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a structured opioid tapering program for patients with persistent spinal pain after back surgery who are being treated with spinal cord stimulation (SCS). Many patients with failed back surgery syndrome become dependent on opioid pain medications, but opioids can blunt the effectiveness of spinal cord stimulation. This trial evaluates whether a guided, medication-assisted taper — using drugs like buprenorphine/naloxone and clonidine to manage withdrawal — can help patients successfully reduce or stop opioids while their pain is managed by SCS. Eligible participants are adults with neuropathic leg and/or back pain after at least one spine surgery, scheduled for spinal cord stimulator implantation, and currently taking opioids. Participants must speak Dutch or French. People being treated for active cancer, with terminal illness, receiving intrathecal drug delivery, or with contraindications to the tapering medications are excluded. Participants follow the tapering protocol and are monitored for pain scores, opioid use, and quality of life. This research addresses a significant problem in chronic pain management: many patients after back surgery end up on long-term opioids with diminishing returns, and spinal cord stimulation works better when opioid use is reduced. A systematic, safe tapering protocol could help patients achieve better pain control with lower medication burden.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREUsual care

Usual care with respect to Spinal Cord Stimulation implantation

PROCEDUREStandardized pain medication tapering

A standardized pain medication tapering program before Spinal Cord Stimulator implantation.

PROCEDUREPersonalized pain medication tapering

A personalized pain medication tapering program before Spinal Cord Stimulator implantation.


Locations(3)

Universitair Ziekenhuis Brussel

Jette, Belgium

Heilig Hart Ziekenhuis Lier

Lier, Belgium

AZ Delta

Roeselare, Belgium

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NCT05861609


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