Evaluation of Online Tool (E-TOOL SCS) in Spinal Cord Stimulaion
CompletedNCT06229015
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- Evaluation of an Online Tool (E-TOOL) in the Selection of Patients for Spinal Cord Stimulation for Chronic Pain
- Conditions
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana
- Start date
- 2021-07-13
- Primary completion
- 2022-01-16
- Sex
- All
- Age range
- from 16 Years
- Results posted
- No results posted in this snapshot
- Countries
- Italy
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * • Males and females aged between 18 and 85 years. * Patients with chronic pain and indication for implantation of a temporary neurostimulator for spinal cord stimulation testing. * Signed informed consent. Exclusion Criteria: * • Patients who, in the researcher's judgment, are unable to follow the protocol instructions. * Patients in presumed/confirmed pregnancy. * Contraindications to implantation.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06229015