Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain (NCT02587637) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain
Netherlands20 participantsStarted 2015-10-01
Plain-language summary
The purpose of this prospective post market observational pilot study is to evaluate the effect of DRG stimulation in the management of chronic discogenic pain in subjects who are refractory to other available treatments. Selected subjects will not be suitable candidates for lumbar spinal surgery and will meet the standard selection process for DRG stimulation as routinely utilised in the study centre. Results from this pilot study will inform current clinical practice and future comparative studies in this specific population.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject of either gender between 18 and 65 years of age
. Subject is able and willing to comply with the follow-up schedule and protocol
. Subject is able to provide written informed consent
. Chronic low back pain of at least 6 months
. History consistent with discogenic low back pain (e.g. Pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance)
. Neurologic exam without marked motor deficit.
. Definite/Highly Probable/Discogenic Pain as confirmed by provocative discography according to IASP/ISIS guidelines\*
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months
Timeframe: 6 months
2
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 12 Months
. Low Back Pain intensity should be 6 or higher measured on a NPRS at baseline
Exclusion criteria
. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
. Escalating or changing pain condition within the past month as evidenced by investigator examination
. BMI ≥35
. Subject has had injection therapy or radiofrequency treatment for their low back pain within the past 3 months
. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
. Subject is unable to operate the device
. Severe disc degeneration at the affected level as evidenced by \>50% disc height loss on plain anteroposterior and lateral lumbar radiographs or CT/MRI.
. Extruded or sequestered herniated nucleus pulposus at the affected level(s).