Subthreshold SCS or BMT
TRADITION
The Holistic Response of Patients With Persistent Spinal Pain Syndrome Type II by Subthreshold Spinal Cord Stimulation Compared to Best Medical Treatment, Investigated by a Multicentric Randomized Controlled Trial
1 other identifier
interventional
114
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2021
CompletedFirst Posted
Study publicly available on registry
December 23, 2021
CompletedStudy Start
First participant enrolled
February 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
October 7, 2025
October 1, 2025
4.5 years
November 29, 2021
October 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical holistic responder status
The clinical holistic responder status as a composite measure represents the global effect of a treatment, based on a combination of questionnaires.
The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Secondary Outcomes (9)
Overall pain intensity with Visual Analogue Scale (VAS)
The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Pain medication use
The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Functional disability
The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Health related quality of life
The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Patient global impression of change
Evaluated at 1 month, 6 months and 12 months.
- +4 more secondary outcomes
Study Arms (2)
Best Medical Treatment
ACTIVE COMPARATORSubthreshold Spinal Cord Stimulation
ACTIVE COMPARATORInterventions
For each patient who is randomized to BMT, an optimal individual treatment plan will be developed by the treating physician.
SCS will be programmed at subthreshold stimulation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moens Maartenlead
Study Sites (5)
Jessa Ziekenhuis
Hasselt, Belgium
Universitair Ziekenhuis Brussel
Jette, 1090, Belgium
Emmaüs, AZ Sint-Maarten
Mechelen, Belgium
AZ Delta
Roeselare, Belgium
AZ Turnhout
Turnhout, Belgium
Related Publications (1)
Goudman L, Putman K, Van Doorslaer L, Billot M, Roulaud M, Rigoard P; TRADITION consortium; Moens M. Proportion of clinical holistic responders in patients with persistent spinal pain syndrome type II treated by subthreshold spinal cord stimulation compared to best medical treatment: a study protocol for a multicentric randomised controlled trial (TRADITION). Trials. 2023 Feb 20;24(1):120. doi: 10.1186/s13063-023-07140-3.
PMID: 36803412DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
November 29, 2021
First Posted
December 23, 2021
Study Start
February 7, 2022
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
October 7, 2025
Record last verified: 2025-10