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

NCT ID: NCT02587637

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2018-01-30

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single device arm

Group Type: OTHER

Dorsal root ganglion (DRG) stimulation

Intervention Type: DEVICE

The role the DRG plays in the development and maintenance of chronic pain, we have developed a neurostimulator system for the management of chronic intractable pain by electrically stimulating the DRG

Interventions

Dorsal root ganglion (DRG) stimulation

The role the DRG plays in the development and maintenance of chronic pain, we have developed a neurostimulator system for the management of chronic intractable pain by electrically stimulating the DRG

Intervention Type: DEVICE

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rijnstate Ziekenhuis, Velp

Velp, Arnhem, Netherlands

Countries

Netherlands

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

28-SMI-2015

Identifier Type: -

Identifier Source: org_study_id