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Evaluation of Online Tool (E-TOOL SCS) in Spinal Cord Stimulaion

NCT06229015 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-03-18

No results posted yet for this study

Summary

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

Conditions

  • Failed Back Surgery Syndrome
  • Limb Ischemia
  • Neuropathic Pain
  • Complex Regional Pain Syndromes

Sponsors & Collaborators

  • Azienda Ospedaliero, Universitaria Pisana

    collaborator OTHER

  • Istituti Clinici Scientifici Maugeri SpA

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-13
Primary Completion
2022-01-16
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06229015 on ClinicalTrials.gov