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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT05761392
Eligibility Criteria:
Inclusion Criteria:
* Have been clinically diagnosed with chronic, intractable pain for more than three months.
* At enrollment, the average pain intensity is no least than 5 out of 10 cm on visual analogue scale.
* At enrollment, the age is no younger than 18-year-old.
* Ineffective or unsatisfactory conservative treatments, including but limited to: oral medication, nerve block, epidural corticosteroids, physical and psychological rehabilitation therapy, and chiropractic care.
* Voluntary to take the trial and sign the informed consent.
* Good compliance and ability to complete post-operative follow-ups.
* Basic ability to read and use a mobile phone or having a caregiver who can.
Exclusion Criteria:
* Bleeding complications or coagulation disorders.
* Mental or cognitive disorders leading to inability to complete implantation surgery or post-operative follow-up.
* Issues with spinal cord or vertebrates that are not suitable for implantation surgery.
* Systemic active infections or local infections around the surgery area.
* Pregnancy, breast-feeding, plan to be pregnant or unwilling to use contraceptive methods.
* Metastatic malignant tumors or untreated malignant tumors.
* Life expectancy of less than one year.
* Already provided with a medication pump and/or other implanted devices.
* Need for therapy or examination that must not have an implanted pulse generator (IPG), such as magnetic resonance imaging (MRI) and thermo-therapy.
* Heavily addicted to alcohol or drugs.
* VAS improvement less than 50% or stimulation intolerance during the test period.
* Unable to complete long-term online follow-ups because of hardware issues such as internet, mobile phones, and so on.
* Unwilling to participate.
* Other inappropriate situations determined by the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05761392
Study Brief:
Protocol Section:
NCT05761392