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

Launched by ISTITUTI CLINICI SCIENTIFICI MAUGERI SPA · Jan 25, 2024

Keywords

ClinConnect Summary

This is an observational, prospective study in two Italian pain centers that is testing an online tool (the SCS-e-tool) to help doctors decide who might benefit from spinal cord stimulation (SCS) for chronic pain. It focuses on four conditions linked to chronic pain: Failed Back Surgery Syndrome, Complex Regional Pain Syndrome, other neuropathic pain, and ischemic limb pain. About 60 adults will be enrolled over about a year, with follow-up for up to about one year after a trial SCS implantation. The study uses routine clinical care and does not replace standard medical or psychological evaluations.

Eligible participants are adults roughly 18 to 85 years old who have chronic pain and are being considered for a temporary SCS trial, and who can give informed consent. Exclusions include those who can’t follow the study, pregnant individuals, or any contraindications to implantation. Participants will receive the usual evaluations and SCS trial as part of standard care, plus use of the e-tool. They’ll be asked about pain levels (0–10), disability in daily life, quality of life, and overall change over time at key points (trial, 6 months, and 12 months). The study looks mainly at how often the doctor’s judgment and the e-tool agree on suitability, and how well the e-tool predicts successful outcomes.

Gender

ALL

Eligibility criteria

• 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.