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Subthreshold SCS or BMT

Study acronym: TRADITION
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 7, 2025 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jan 2024 to Aug 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Aug 2024 to Aug 2026
    • Site details revised at 5 of 5 sites
    v5
  2. Site details revised at 2 of 5 sitesv4
  3. Site details revised at 2 of 5 sitesv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2021 to Feb 7, 2022
    • Site details revised at 5 of 5 sites
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Given the substantial socioeconomic impact of Spinal Cord Stimulation (SCS) implantations and given that currently no direct high-quality evidence with a relevant outcome measurement is available to guide the treatment choice between subthreshold SCS versus best medical treatment in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS-T2), we here propose a scientifically well-constructed randomized controlled trial to answer this question. The primary scientific objective is to examine whether subthreshold SCS, compared to best medical treatment, provided to patients with PSPS-T2 results in a higher percentage of clinical holistic responders at 6 months. The secondary objective of the study is to examine if subthreshold SCS compared with BMT is having more efficacy in improving patients' individual competencies for self-management, increasing the likelihood to return to work, work status and healthcare expenditure, improving pain relief, obtaining pain medication reduction, decreasing anxiety and depression, increasing quality of life and decreasing disability.
Trial Details
NCT Number NCT05169047
Lead Sponsor Moens Maarten
Conditions
(from sponsor)		 Failed Back Surgery Syndrome
Related terms Failed Back Surgery Syndrome
Enrollment 114 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov