Subthreshold SCS or BMT

Last updated: December 11, 2023
Sponsor: Moens Maarten
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Best Medical Treatment

Subthreshold Spinal Cord Stimulation

Clinical Study ID

NCT05169047
TRADITION
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Persistent Spinal Pain Syndrome Type II (PSPS-T2)
  • Chronic pain as a result of PSPS-T2 that exists for at least 6 months with a painintensity of at least 4/10 on the Numeric Rating Scale, refractory to conservativetreatment.
  • PSPS-T2 patients eligible for subthreshold SCS
  • Age > 18 years
  • Patient has been informed of the study procedures and has given written informedconsent
  • Patient willing to comply with study protocol including attending the study visits

Exclusion

Exclusion Criteria:

  • Expected inability of patients to receive or properly operate the spinal cordstimulation system
  • Evidence of an active psychiatric disorder
  • Suffering from another chronic illness characterised by chronic generalized widespreadpain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma).
  • Pregnancy

Study Design

Total Participants: 114
Treatment Group(s): 2
Primary Treatment: Best Medical Treatment
Phase:
Study Start date:
February 07, 2022
Estimated Completion Date:
August 31, 2024

Study Description

After filling in the questionnaires at the 6 months follow-up visit, patients could change treatment groups (in both directions). This decision will be a shared decisions between patient and treating physician in case the randomized intervention did not provided enough pain relief.

Connect with a study center

  • Jessa Ziekenhuis

    Hasselt,
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Brussel

    Jette, 1090
    Belgium

    Active - Recruiting

  • Emmaüs, AZ Sint-Maarten

    Mechelen,
    Belgium

    Active - Recruiting

  • AZ Delta

    Roeselare,
    Belgium

    Active - Recruiting

  • AZ Turnhout

    Turnhout,
    Belgium

    Active - Recruiting

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