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NCT Number: NCT05169047

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 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Failed Back Surgery Syndrome Back Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Ziekenhuis, Hasselt, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Medical Treatment

Other

For each patient who is randomized to BMT, an optimal individual treatment plan will be developed by the treating physician.

Subthreshold Spinal Cord Stimulation

Other

SCS will be programmed at subthreshold stimulation.

Primary outcomes

  1. Clinical holistic responder status

    Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.

    The clinical holistic responder status as a composite measure represents the global effect of a treatment, based on a combination of questionnaires.

Secondary outcomes

  1. Overall pain intensity with Visual Analogue Scale (VAS)

    Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.

    Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm)

  2. Pain medication use

    Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.

    Open question regarding the dosage, frequency and type of pain medication

  3. Functional disability

    Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.

    The functional disabilities will be assessed with the Oswestry Disability Index (ODI)

  4. Health related quality of life

    Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.

    Health related quality of life, evaluated with the EuroQol with five dimensions and 5 levels

  5. Patient global impression of change

    Time frame: Evaluated at 1 month, 6 months and 12 months.

    Patients will be asked to quantify the impression of change after treatment using the Patient Global Impression of Change scale (PGIC).

  6. Work status

    Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.

    Work status is evaluated with a self-designed questionnaire

  7. Patients' individual competencies for self-management

    Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.

    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.

  8. Healthcare utilisation.

    Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.

    Healthcare expenditure will be investigated by self-reporting methods.

  9. Anxiety and Depression.

    Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.

    The hospital Anxiety and Depression Scale (HADS) will measure symptoms of anxiety and depression

Sponsors and collaborators

Lead sponsor

Moens Maarten

Other

Registry information

Official study title

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

Acronym: TRADITION

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2021
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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