Prospective Validation Study of an E-health Tool for Patient Selection for SCS

Not yet recruiting

• Conditions: Pain, Chronic

• Registration Number: NCT06853795
• Lead Sponsor: Erasmus Medical Center

Brief Summary

The goal of this observational study is to learn more about the selection of patients with chronic pain for spinal cord stimulation. The main question it aims to answer is to assess the predictive value of an e-health tool for patient outcomes.

Participants will be treated as normal and will be asked to complete patient questionnaires to evaluate their pain relief after receiving spinal cord stimulation. The e-health tool will not be used during the conduct of the study, as patient outcomes will only at the end of the study be compared with the recommendations made by the e-health tool.

Detailed Description

This is a multicentre study within Europe, prospectively collecting data from patients with a positive decision on SCS, receiving either a direct implant or an SCS screening trial. Data will be collected by implant centres who have not previously used the e-health tool for SCS patient selection (i.e. tool-naïve). Furthermore, participating centres should declare neither to use the tool during the conduct of study nor on patients included in the study population. In addition, participating implant centres should have previous experience in conducting prospective clinical trials.

Baseline data should be collected at the moment of the final decision on SCS (i.e., after multidisciplinary team consultation if applicable) using an online data capture program:

* General baseline data

* e-Health tool variables

* Centre decision on SCS (direct implant or trial)

Only for patients receiving SCS (direct implant or positive trial), follow-up data at 6 and 12 months will be collected.

Afterwards, the prospectively collected data will be applied to the e-health tool and its recommendations compared with the centre decisions, trial results and patient outcomes.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study Start: 2025-03-01
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Primary Completion: 2026-10-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
e-health tool predictive value	12 months	Assessment of the predictive value of the panel recommendations (i.e., not recommended, recommended, highly recommended) embedded in the SCS e-health tool for patient outcomes (a). trial outcome: positive/negative, based on Numeric Pain Rating Scale, range 0-10; b).pain-related outcomes after SCS implant: EQ-5D-5L (range 5-25), Brief Pain Inventory (range 0-10), Global Perceived Effect (range 1-7).

Secondary Outcome Measures

Name	Time	Method
Relationship between panel recommendations with centre decisions	1 week	Assessment of the relationship between the panel recommendations (i.e., not recommended, recommended, highly recommended) embedded in the SCS e-health tool with the centre decisions (positive=proceed with SCS; negative=no SCS; defer=reassess in a later phase).
Trial results	1 week	Assessment of the predictive value of the panel recommendations (i.e., not recommended, recommended, highly recommended) embedded in the e-health tool for trial results (% pain reduction on Numeric Pain Rating Scale; range 0-10).