Failed Back Surgery SyndromeTRADITIONNCT05169047
Subthreshold SCS or BMT
A study testing Best Medical Treatment and Subthreshold Spinal Cord Stimulation in people with Failed Back Surgery Syndrome, run by Moens Maarten at 5 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- Best Medical Treatment and Subthreshold Spinal Cord Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 5 sitesBelgium
- Study dates
- 7 Feb 2022to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
Jessa Ziekenhuis
Hasselt
Universitair Ziekenhuis Brussel
Jette, 1090
Emmaüs, AZ Sint-Maarten
Mechelen
AZ Delta
Roeselare
AZ Turnhout
Turnhout
About this study
Official 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
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.
Read the 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.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- Best Medical Treatment, Subthreshold Spinal Cord Stimulation
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Medical TreatmentOther
For each patient who is randomized to BMT, an optimal individual treatment plan will be developed by the treating physician.
Subthreshold Spinal Cord StimulationOther
SCS will be programmed at subthreshold stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Best Medical Treatment | Active comparator | Not described Receives: Other: Best Medical Treatment |
| Subthreshold Spinal Cord Stimulation | Active comparator | Not described Receives: Other: Subthreshold Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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).
Measured: Evaluated at 1 month, 6 months and 12 months.
Work status
Work status is evaluated with a self-designed questionnaire
Measured: 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.
Measured: 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.
Measured: 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
Measured: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start7 Feb 2022
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moens Maarten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moens Maarten, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169047
- Sponsor's protocol ID
- TRADITION
- Acronym
- TRADITION
- Status last verified
- Oct 2025
- First submitted
- 29 Nov 2021
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36803412
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05169047
- Acronym / sponsor ID
- TRADITION / TRADITION
- Conditions
- Failed Back Surgery Syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Moens MaartenUniversity, hospital or other
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best Medical Treatment | Active comparator | Other: Best Medical Treatment |
| Subthreshold Spinal Cord Stimulation | Active comparator | Other: Subthreshold Spinal Cord Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best Medical TreatmentFor each patient who is randomized to BMT, an optimal individual treatment plan will be developed by the treating physician. | Other | Best Medical Treatment |
| Subthreshold Spinal Cord StimulationSCS will be programmed at subthreshold stimulation. | Other | Subthreshold Spinal Cord Stimulation |
Primary outcome
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.
9 secondary outcomes
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.
Pain medication use
Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Functional disability
Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Health related quality of life
Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Patient global impression of change
Time frame: Evaluated at 1 month, 6 months and 12 months.
Work status
Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
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.
Healthcare utilisation.
Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Anxiety and Depression.
Time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Derived from this study: PubMed 36803412Goudman 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.
- Study protocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Medical Treatment and Subthreshold Spinal Cord Stimulation in people with Failed Back Surgery Syndrome, run by Moens Maarten at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical holistic responder status (time frame: The change between the baseline screening and the evaluation at 1 month, 6 months and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05169047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.