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

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.

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