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

Discogenic Low Back Pain Clinical Trial

Official title:

A Prospective Post Market Observational Pilot Study to Evaluate the Effectiveness of DRG Stimulation in the Treatment of Discogenic Low Back Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02587637
• Other study ID #: 28-SMI-2015
• Status: Active, not recruiting
• Phase: N/A
• First received: October 22, 2015
• Last updated: January 16, 2017
• Start date: October 2015
• Est. completion date: January 2018

Study information

• Verified date: January 2017
• Source: St. Jude Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Discogenic Low Back Pain
• Low Back Pain

Intervention

Device:
• Dorsal Root Ganglion Stimulation

Locations

Country	Name	City	State
Netherlands	Rijnstate Ziekenhuis, Velp	Velp	Arnhem

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Medical

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Relief	To determine 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 and 12 month follow up visits as compared to baseline.	Change in pain intensity at 6 and 12 months post implantation of the stimulation device as compared to baseline scores