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:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT03201705
Eligibility Criteria:
Inclusion Criteria:
* Chronic, persistent, refractory, low back pain as a result of spinal surgery
* Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and minimally interventional pain procedures for chronic pain
* Pain radiating in the leg, following segments L4 and/or L5 and/or S1 for at least 6 months
* Minimum baseline pain intensity as assessed by VAS of ≥ 50mm on 100mm scale in the primary pain area
* Subject is able and willing to provide informed consent
* Subject is able and willing to comply with the protocol and follow-up schedule
Exclusion Criteria:
* Back pain component of more than 20% or VAS \> 40mm on 100mm scale
* Bilateral limb pain
* Subjects with a previous SCS implantation
* Changes in pain medication in the 2 months preceding the trial period
* Expected inability of subjects to correctly operate the neurostimulation system
* Presence of any other clinically significant or disabling chronic pain condition (eg. hip arthrosis, rheumatoid arthritis, fibromyalgia, etc.)
* History of coagulation disorders, lupus erythematosus, diabetes mellitus
* Symptoms or proof of any malignant disease
* Current use of medicines affecting coagulation which cannot be temporarily stopped
* Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
* Life expectancy of less than 1 year
* Existing or planned pregnancy in the trial period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03201705
Study Brief:
Protocol Section:
NCT03201705