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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Failed Back Surgery Syndrome
• Intervention / Treatment: Other: Best Medical Treatment; Other: Subthreshold Spinal Cord Stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Hasselt, Belgium
    • Jessa Ziekenhuis
  • Jette, Belgium, 1090
    • Universitair Ziekenhuis Brussel
  • Mechelen, Belgium
    • Emmaüs, AZ Sint-Maarten
  • Roeselare, Belgium
    • AZ Delta
  • Turnhout, Belgium
    • AZ Turnhout

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Best Medical Treatment	Other: Best Medical Treatment; For each patient who is randomized to BMT, an optimal individual treatment plan will be developed by the treating physician.
Active Comparator: Subthreshold Spinal Cord Stimulation	Other: Subthreshold Spinal Cord Stimulation; SCS will be programmed at subthreshold stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall pain intensity with Visual Analogue Scale (VAS)	Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm)	The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Pain medication use	Open question regarding the dosage, frequency and type of pain medication	The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Functional disability	The functional disabilities will be assessed with the Oswestry Disability Index (ODI)	The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Health related quality of life	Health related quality of life, evaluated with the EuroQol with five dimensions and 5 levels	The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Patient global impression of change	Patients will be asked to quantify the impression of change after treatment using the Patient Global Impression of Change scale (PGIC).	Evaluated at 1 month, 6 months and 12 months.
Work status	Work status is evaluated with a self-designed questionnaire	The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Patients' individual competencies for self-management	Patient activation measure-13 (PAM) is a 13-item instrument which assesses self-reported behaviour, knowledge, and confidence for self-management of one's health.	The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Healthcare utilisation.	Healthcare expenditure will be investigated by self-reporting methods.	The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Anxiety and Depression.	The hospital Anxiety and Depression Scale (HADS) will measure symptoms of anxiety and depression	The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.

Collaborators and Investigators

• Sponsor: Moens Maarten

Publications and helpful links

General Publications

• 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.

Helpful Links

• Study protocol

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Failed Back Surgery Syndrome
• Other Study ID Numbers: TRADITION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No