Subthreshold SCS or BMT

Failed Back Surgery Syndrome Clinical Trial

— TRADITION  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05169047
• Other study ID #: TRADITION
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Maarten Moens, Prof. dr.
• Phone: +3224775514
• Email: maarten.moens[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: August 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	Universitair Ziekenhuis Brussel	Jette
Belgium	Emmaüs, AZ Sint-Maarten	Mechelen
Belgium	AZ Delta	Roeselare
Belgium	AZ Turnhout	Turnhout

Sponsors (1)

Lead Sponsor	Collaborator
Moens Maarten

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   Study protocol