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Active Not RecruitingNANCT05169047

Subthreshold SCS or BMT

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 g...

Lead sponsor: Moens Maarten•5 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Moens Maarten

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 7, 2025Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

PhaseNA

Enrollment114

Start dateFeb 2022

Last updatedOct 7, 2025

Condition

Failed Back Surgery Syndrome

Locations shown

Jessa Ziekenhuis

Hasselt

Universitair Ziekenhuis Brussel

Jette

Emmaüs, AZ Sint-Maarten

Mechelen

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 7, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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