Clinical trial NCT02587637: Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain
Official title: A Prospective Post Market Observational Pilot Study to Evaluate the Effectiveness of DRG Stimulation in the Treatment of Discogenic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Low Back Pain
Dorsal Root Ganglion
Neurostimulator System
spinal cord stimulation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Subject of either gender between 18 and 65 years of age
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Subject is able to provide written informed consent
4. Chronic low back pain of at least 6 months
5. History consistent with discogenic low back pain (e.g. Pain produced on lumbar motion, significant functional limitation in sitting duration and tolerance)
6. Neurologic exam without marked motor deficit.
7. Definite/Highly Probable/Discogenic Pain as confirmed by provocative discography according to IASP/ISIS guidelines\*
8. Low Back Pain intensity should be 6 or higher measured on a NPRS at baseline
9. Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilised in the study centre
10. Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation

Exclusion Criteria:

1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. BMI ≥35
4. Subject has had injection therapy or radiofrequency treatment for their low back pain within the past 3 months
5. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
6. Subject is unable to operate the device
7. Severe disc degeneration at the affected level as evidenced by \>50% disc height loss on plain anteroposterior and lateral lumbar radiographs or CT/MRI.
8. Extruded or sequestered herniated nucleus pulposus at the affected level(s).
9. Previous lumbar back surgery (e.g. Laminectomy, discectomy or fusion) at the affected level(s)
10. Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT in the previous 6 months
11. Moderate to severe endplate degenerative changes at the affected levels
12. Grade 1-2 spondylolisthesis
13. Previous Neurostimulation therapy

Primary outcomes:
measure: Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months
timeFrame: 6 months
measure: Percentage of Subjects With 30% or Greater Reduction in Back Pain at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Patients With Improved Global Impression of Change at 6 Months
timeFrame: 6 Months
measure: Percentage of Patients With Improved Global Impression of Change at 12 Months Using Trial System
timeFrame: 12 Months
measure: Percentage of Subjects With 50% or Greater Reduction in Back Pain at 6 Months
timeFrame: 6 Months
measure: Percentage of Subjects With 50% or Greater Reduction in Back Pain at 12 Months
timeFrame: 12 Months
Other outcomes:
Locations:
city: Velp
country: Netherlands
facility: Rijnstate Ziekenhuis, Velp
state: Arnhem
Study officials:
References: