Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-24 @ 1:39 PM
NCT ID:
NCT06853795
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06853795
Study Brief:
Protocol Section:
NCT06853795