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

NCT02587637 | Completed Results

• 1 other identifier: 28-SMI-2015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic Low Back Pain; Dorsal Root Ganglion; Neurostimulator System; spinal cord stimulation

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects With 30% or Greater Reduction in Back Pain at 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.

  6 months

• Percentage of Subjects With 30% or Greater Reduction in Back Pain at 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.

  12 months

Secondary Outcomes (4)

• Percentage of Patients With Improved Global Impression of Change at 6 Months

  6 Months

• Percentage of Patients With Improved Global Impression of Change at 12 Months Using Trial System

  12 Months

• Percentage of Subjects With 50% or Greater Reduction in Back Pain at 6 Months

  6 Months

• Percentage of Subjects With 50% or Greater Reduction in Back Pain at 12 Months

  12 Months

Study Arms (1)

Single device arm

OTHER

Device: Dorsal root ganglion (DRG) stimulation

Interventions

Dorsal root ganglion (DRG) stimulation 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

Single device arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Rijnstate Ziekenhuis, Velp

Velp, Arnhem, 6883 AZ Velp, Netherlands

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Robyn Capobianco
• Organization: Abbott

robyn.capobianco@abbott.com

+1 512 286 4274

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 27, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: January 30, 2018
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Locations

NL (1)