N/A N=20 Treatment

Study to Evaluate the Effectiveness of DRG Stimulation for Discogenic Low Back Pain

Chronic Pain

Bottom Line

View on ClinicalTrials.gov: NCT02587637 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months — 11 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dorsal root ganglion (DRG) stimulation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abbott Medical Devices
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months	11	—
PRIMARY Percentage of Subjects With 30% or Greater Reduction in Back Pain at 12 Months	13	—
SECONDARY Percentage of Patients With Improved Global Impression of Change at 6 Months	10	—
SECONDARY Percentage of Patients With Improved Global Impression of Change at 12 Months Using Trial System	11	—
SECONDARY Percentage of Subjects With 50% or Greater Reduction in Back Pain at 6 Months	11	—
SECONDARY Percentage of Subjects With 50% or Greater Reduction in Back Pain at 12 Months	11	—

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

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
Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilised in the study centre
Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation

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).
Previous lumbar back surgery (e.g. Laminectomy, discectomy or fusion) at the affected level(s)
Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT in the previous 6 months
Moderate to severe endplate degenerative changes at the affected levels
Grade 1-2 spondylolisthesis
Previous Neurostimulation therapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02587637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.