NCT04587674: PREDIBACK 2

Identification of Outcome Predictors and Stratification of Responder Profiles Implanted With Spinal Cord Stimulation. An AI-based-pathway & Algorithmic Approach to Treat Failed Back Surgery Syndrome Patients

Completed NA Last updated 30 May 2025

What this trial tests

NA trial testing Spinal Cord Stimulation in Pain, Intractable in 110 participants. Completed in 16 May 2025.

Timeline

19 April 2021

Primary endpoint
19 June 2024

16 May 2025

Quick facts

Lead sponsor	Poitiers University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	110
Start date	19 April 2021
Primary completion	19 June 2024
Estimated completion	16 May 2025
Sites	7 locations across France

Drugs / interventions tested

• Spinal Cord Stimulation

Conditions studied

• Pain, Intractable — all drugs for Pain, Intractable →

Sponsor

Poitiers University Hospital

Who can join

Adults 18 to 80, any sex, with Pain, Intractable. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Failed Back Surgery Syndrome is commonly defined as new, recurrent, or persistent pain in the back and/or leg(s) of at least 6-month duration following spinal surgery. The literature estimates that 10-50% of patients undergoing spinal surgery are likely to develop such pain, representing a substantial financial burden. Among them, 5-10% would suffer from severe pain, which are intense, neuropathic and generally refractory to conventional therapeutic strategies considerably affect patients' functional capacity as well as their psychological and social well-being.

Spinal Cord Stimulation (SCS) is a well-established therapy to alleviate severe intractable neuropathic pain such as FBSS. SCS is a safe and reversible treatment option, which leads to improvement in pain relief and quality of life for patients with FBSS. Despite encouraging results in a chronic painful patient population that is refractory to conventional therapies, the literature estimates that only 58% \[53% - 64%\] of patients implanted with SCS devices achieved adequate pain relief.

FBSS population characterization and stratification and predictive modeling of SCS outcome are thus crucial to delineate future treatment options and to deliver neuromodulation therapy to the right patient.

The investigators designed a clinical prospective project based on SCS outcome optimization and SCS candidates' stratification: PREDIBACK 2.

This study would be a following part of a continuous project (PREDIBACK) that aims to better understand and stratify the therapies (drugs, surgery, psychological therapy or SCS) proposed to FBSS patients. The goal of PREDIBACK 1 was to develop a decision tool that simplifies the therapeutic decision process.

PREDIBACK 2 will focus on the neuromodulation pathway. Easing and helping patient orientation should improve referral yielding to specialists and accelerate patient flow through care pathway. Hence, facilitating access to adequate therapies for FBSS patients who usually have a longstanding history of pain.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.