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Pain medication tapering for patients with Persistent Spinal Pain Syndrome Type II, treated with Spinal Cord Stimulation.

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516647-79-00
Enrollment
195
Registered
2024-10-18
Start date
2023-06-28
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Spinal Pain Syndrome Type II (PSPS T2)

Brief summary

The primary endpoint is to observe whether there is a difference in the ODI score in patients with chronic lower back pain 12 months after an intervention focusing on pain relief for axial problems between the three arms. A longitudinal mixed model analysis will be used with timepoints defined at baseline, 1 month, 3 months, 6 months, and 12 months after the intervention.

Interventions

DRUGCatapressan 150 microgrammes /1 ml solution injectable/solution pour perfusion
DRUGOxyNorm Instant 5 mg
DRUGcomprimés orodispersibles
DRUGOxyNorm Instant 10 mg
DRUGLibroxar 8 mg / 2 mg comprimés sublinguaux
DRUGLibroxar 2 mg/0.5 mg Sublingualtabletten
DRUGCatapressan 150 microgrammes comprimés
DRUGOxyNorm Instant 20 mg

Sponsors

Vrije Universiteit Brussel
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is to observe whether there is a difference in the ODI score in patients with chronic lower back pain 12 months after an intervention focusing on pain relief for axial problems between the three arms. A longitudinal mixed model analysis will be used with timepoints defined at baseline, 1 month, 3 months, 6 months, and 12 months after the intervention.

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026