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

NCT ID: NCT06853795

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-01-01

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.

Conditions

Pain, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic pain patients eligible for spinal cord stimulation

Patients with chronic pain with a positive decision on SCS. Those receiving either a direct implant or a positive screening trial will be followed at 6 and 12 months after receiving SCS

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Chronic pain with a duration of least 6 months
• One of the following primary indications: Persistent Spinal Pain Syndrome (PSPS) (type 1 and type 2), Complex Regional Pain Syndrome, Neuropathic Pain Syndrome, Ischaemic Pain Syndrome
• Pain severity at least moderate (VAS ≥ 5, on average over the last month) having a substantial impact on daily functioning and quality of life at the discretion of the attending physician
• Insufficiently responding to appropriate trials of medication, conservative management (e.g. physiotherapy) and/or minimally invasive treatments (such as local anaesthetic nerve blocks), and/or experiencing intolerable side effects of these treatments
• No clear benefits of surgery expected

Exclusion Criteria

• Unwilling to have an implant
• Unable to manage the device
• Absolute contra-indications for active treatment (e.g. unfit for undergoing SCS, pregnancy, spine- or skin-related infections, coagulation disorder)
• Uncontrolled disruptive psychological or psychiatric disorder at the discretion of the attending physician
• Ongoing alcohol and drug misuse
• Widespread pain
• Lack of reimbursement of SCS

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Frank Huygen

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Herman Stoevelaar, PhD

Role: STUDY_DIRECTOR

Ismar Healthcare

Central Contacts

Herman Stoevelaar, PhD

Role: CONTACT

herman.stoevelaar@ismar.com

+3134856072

Frank Huygen, MD, PhD

Role: CONTACT

f.huygen@erasmusmc.nl

+31107034906

Other Identifiers

SCS e-health tool

Identifier Type: -

Identifier Source: org_study_id