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

NCT06229015 | Completed

• 1 other identifier: 2506 CE
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Spinal cord stimulation; SCS-E-TOOL; Chronic Pain Treatment

Outcome Measures

Primary Outcomes (1)

• Numerical rating scale

  Numeric Rating Scale (NRS): a scale for pain intensity assessment useful for controlling therapies, clinical routine monitoring, and scientific studies. The result is the indication of pain intensity on a scale from 0 to 10, where 0 indicates no pain, and 10 indicates the maximum imaginable pain

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Evaluate the ability of the E-TOOL to classify interventions defined as appropriate and highly likely to succeed

  perioperatively/periprocedurally

• Oswestry Disability Index

  through study completion, an average of 1 year

• European Quality of life, EuroQol

  through study completion, an average of 1 year

• Patient global impression of change (PGIC)

  through study completion, an average of 1 year"

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic pain afferent to pain therapy units in ICS Maugeri hospital Pavia or in University Hospital Pisa

You may qualify if:

• 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.

You may not qualify if:

• Patients who, in the researcher's judgment, are unable to follow the protocol instructions.
• Patients in presumed/confirmed pregnancy.
• Contraindications to implantation.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Azienda Ospedaliero, Universitaria Pisana: collaborator

Study Sites (1)

ICSMaugeri Spa

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Neuralgia; Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 29, 2024
• Study Start: July 13, 2021
• Primary Completion: January 16, 2022
• Study Completion: December 31, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

IT (1)