Last reviewed · How we verify
NCT06229015: E-TOOLSCS
Evaluation of Online Tool (E-TOOL SCS) in Spinal Cord Stimulaion
trial in Failed Back Surgery Syndrome in 80 participants. Completed in 31 December 2025.
16 January 2022
Quick facts
| Lead sponsor | Istituti Clinici Scientifici Maugeri SpA |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 80 |
| Start date | 13 July 2021 |
| Primary completion | 16 January 2022 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Italy |
Conditions studied
- Failed Back Surgery Syndrome — all drugs for Failed Back Surgery Syndrome →
- Limb Ischemia — all drugs for Limb Ischemia →
- Neuropathic Pain — all drugs for Neuropathic Pain →
- Complex Regional Pain Syndromes — all drugs for Complex Regional Pain Syndromes →
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Who can join
16 and older, any sex, with Failed Back Surgery Syndrome or Limb Ischemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This observational multicenter study aims to evaluate the reliability and validity of the e-tool for selecting patients eligible for SCS for chronic pain caused by one of the four etiologies listed above in the experience of daily clinical practice. The implantation procedure and devices used will be those used in the routine clinical practice of participating centers. Since the study is observational, the use of the e-tool will not replace the routine medical and psychological evaluation in participating centers before SCS implantation. Study Objectives: Primary Objective: Evaluate the degree of agreement/disagreement between the physicians opinion and the e-tool in selecting patients eligible for spinal cord stimulation for chronic pain. Endpoint: Calculation of the probability of disagreement (πD) between the e-tool and the physicians opinion regarding the appropriateness of the intervention. Secondary Objective: Evaluate the ability of the e-tool to classify interventions defined as appropriate and highly likely to succeed; (scores 7-9) at 3 different time points: trial, 6-month follow-up, and 12-month follow-up. The proportion of interventions that were successful at the trial implantation in different time points will be compared with the proportion of interventions identified as appropriate and highly likely to succeed by the e-tool. Study Period: 24 months. 12 months of enrollment + 12 months of follow-up. Subjects: Number of subjects to be included: at least 60 (total divided between the two centers) Participating Centers: * Pain Therapy Unit - ICSMaugeri, Pavia * Anesthesia and Pain Therapy SD - Azienda Ospedaliero Universitaria Pisana Pisa
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06229015
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Failed Back Surgery Syndrome
Currently open trials in the same condition.
- NCT07488936 — Effects of Low Back Pain Types on Pain Severity and Quality of Life in Patients With Failed Back Surgery Syndrome · recruiting
- NCT07050290 — Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level · NA · recruiting
- NCT06272539 — Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome · NA · recruiting
- NCT05754190 — Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA · recruiting
- NCT05421273 — Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syn · NA · recruiting
Other Istituti Clinici Scientifici Maugeri SpA trials
Trials by the same sponsor.
- NCT07521436 — Awareness of Risk Factors and Perception of Cardiovascular Risk in Secondary Prevention Among Women and Men · not yet recruiting
- NCT07451977 — Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia · NA · recruiting
- NCT07448181 — Real-life Ecological Momentary Assessment of Lived Burden in Hereditary AngioEdema · recruiting
- NCT07432204 — Therapeutic Music Listening in Post Stroke Patients. · NA · recruiting
- NCT07399418 — TRIAD - Tracking Risk in Integrated Alzheimer's Diagnostics. · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06229015 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituti Clinici Scientifici Maugeri SpA
- Last refreshed: 18 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06229015.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing