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

Not Applicable

• Conditions: Chronic Pain
• Interventions: Device: Dorsal root ganglion (DRG) stimulation

• Registration Number: NCT02587637
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18
• Primary Completion: 2017-12
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single device arm	Dorsal root ganglion (DRG) stimulation	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months	6 months	The number (percentage) of subjects who achieve a sustained and clinically meaningful reduction in the intensity of LBP of ≥30% or 2 points on a numerical pain rating scale (NPRS) in the implanted subjects at 6 month follow-up visit as compared to baseline.
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 12 Months	12 months	The number (percentage) of subjects who achieve a sustained and clinically meaningful reduction in the intensity of LBP of ≥30% or 2 points on a numerical pain rating scale (NPRS) in the implanted subjects at 12 month follow-up visit as compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Improved Global Impression of Change at 6 Months	6 Months	The subject was requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale (much worse, worse, somewhat worse, no change, slightly better, better and much better). Patients who reported to be much better or better are counted.
Percentage of Patients With Improved Global Impression of Change at 12 Months Using Trial System	12 Months	The subject was requested to rate their overall change in activity limitations, symptoms, emotions and overall quality of life related to his/her condition on a seven-point categorical scale (much worse, worse, somewhat worse, no change, slightly better, better and much better). Patients who reported to be much better or better are counted.
Percentage of Subjects With 50% or Greater Reduction in Back Pain at 6 Months	6 Months	Subjects experiencing 50% or more reduction in the intensity of the back pain.
Percentage of Subjects With 50% or Greater Reduction in Back Pain at 12 Months	12 Months	Subjects experiencing 50% or more reduction in the intensity of the back pain.

Trial Locations

Locations (1)

Rijnstate Ziekenhuis, Velp; 🇳🇱 Velp, Arnhem, Netherlands