TBM (Applied Biomedical Research with a Primary Societal finality) project : Opioid detoxification for patients with Persistent Spinal Pain Syndrome Type II, treated with Spinal Cord Stimulation.

Project Details

Description

Persisting Spinal Pain Syndrome Type II (PSPS T2) is a condition in which
patients are suffering from persistent low back pain, despite previously
performed surgical interventions. Patients with PSPS T2 have chronic
pain with an enormous impact on the functioning, quality of life, general
well-being and medication use. One way to help patients to alleviate
their pain, is with Spinal Cord Stimulation (SCS).
SCS is able to provide pain relief and a decrease in disability but also to
decrease the amount of pain medication and more specifically opioid
intake. Nevertheless, the number of patients that can eventually totally
omit the use of opioids is rather limited.
In this project, we propose to start with an opioid tapering program
before starting the SCS trajectory as the new treatment strategy for
patients implanted with SCS. This allows us to tackle the high burden of
patients that are taken a lot of opioids by proceeding towards a more
logical treatment plan for a costly and debilitating condition.
A three-arm multicenter randomized controlled trial will be conducted
to evaluate whether an opioid tapering program before SCS
implantation (Intervention) is more effective in reducing disability
(Outcome) after 12 months in PSPS T2 patients scheduled for SCS
implantation (Patient) compared with usual care (Comparison). Two
different tapering programs will be evaluated in this project. Opioid
tapering will be provided to 220 patients during a hospital stay of 7 days,
compared to 110 patients who do not undergo opioid tapering before
SCS implantation. Besides disability as primary outcome measure,
several secondary outcome measurements will be collected namely pain
intensity, quality of life, participation, domains affected by substance
use, anxiety and depression, medication use and health expenditure.
Outcome measurements will be collected at baseline, and after 1
month, 3, 6 and 12 months of SCS.
AcronymFWOTBM10
StatusActive
Effective start/end date1/10/2230/09/26

Flemish discipline codes

  • Pain medicine anesthesiology

Keywords

  • Pain medicine anesthesiology
  • Neurosurgery