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 range18 Years – 65 Years
SexALL
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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\*
✓. 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
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
✕. 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).