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

NCT05861609 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2023-10-18

No results posted yet for this study

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.

Conditions

  • Persistent Spinal Pain Syndrome Type 2
  • Spinal Cord Stimulation

Interventions

PROCEDURE

Usual care

Usual care with respect to Spinal Cord Stimulation implantation

PROCEDURE

Standardized pain medication tapering

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

PROCEDURE

Personalized pain medication tapering

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

Sponsors & Collaborators

  • Vrije Universiteit Brussel

    collaborator OTHER

  • Moens Maarten

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-29
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05861609 on ClinicalTrials.gov