Subthreshold SCS or BMT (TRADITION)

  • STATUS
    Recruiting
  • End date
    Aug 9, 2024
  • participants needed
    114
  • sponsor
    Moens Maarten
Updated on 9 June 2022

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.

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.

Details
Condition Failed Back Surgery Syndrome
Treatment Best medical treatment, Subthreshold Spinal Cord Stimulation
Clinical Study IdentifierNCT05169047
SponsorMoens Maarten
Last Modified on9 June 2022

Eligibility

Yes No Not Sure

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 pain intensity of at least 4/10 on the Numeric Rating Scale, refractory to conservative treatment
PSPS-T2 patients eligible for subthreshold SCS
Age > 18 years
Patient has been informed of the study procedures and has given written informed consent
Patient willing to comply with study protocol including attending the study visits

Exclusion Criteria

Expected inability of patients to receive or properly operate the spinal cord stimulation system
Evidence of an active psychiatric disorder
Suffering from another chronic illness characterised by chronic generalized widespread pain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma)
Pregnancy
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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