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CompletedNCT02587637Updated Sep 19, 2024Results posted

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

An interventional study of Dorsal root ganglion (DRG) stimulation in Chronic Pain, sponsored by Abbott Medical Devices. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Pain

Keywords

  • Chronic Low Back Pain
  • Dorsal Root Ganglion
  • Neurostimulator System
  • spinal cord stimulation
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 20 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    Single device arm

    Device: Dorsal root ganglion (DRG) stimulation

Interventions

  • DeviceDorsal 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 12 months

Secondary outcomes

  1. Percentage of Patients With Improved Global Impression of Change at 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.

    Time frame: 6 Months

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

    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.

    Time frame: 12 Months

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

    Subjects experiencing 50% or more reduction in the intensity of the back pain.

    Time frame: 6 Months

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

    Subjects experiencing 50% or more reduction in the intensity of the back pain.

    Time frame: 12 Months

07

Results

Posted Sep 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneAll Subjects
Started20
Received intervention15
Completed14
Not completed6

Outcome measures

PrimaryPercentage 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.

Time frame:
6 months
Reported as:
Count of participants · Participants
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months
ParticipantsAll Subjects
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months11
PrimaryPercentage 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.

Time frame:
12 months
Reported as:
Count of participants · Participants
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 12 Months
ParticipantsAll Subjects
Percentage of Subjects With 30% or Greater Reduction in Back Pain at 12 Months13
SecondaryPercentage of Patients With Improved Global Impression of Change at 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.

Time frame:
6 Months
Reported as:
Count of participants · Participants
Percentage of Patients With Improved Global Impression of Change at 6 Months
ParticipantsAll Subjects
Percentage of Patients With Improved Global Impression of Change at 6 Months10
SecondaryPercentage of Patients With Improved Global Impression of Change at 12 Months Using Trial System

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.

Time frame:
12 Months
Reported as:
Count of participants · Participants
Percentage of Patients With Improved Global Impression of Change at 12 Months Using Trial System
ParticipantsAll Subjects
Percentage of Patients With Improved Global Impression of Change at 12 Months Using Trial System11
SecondaryPercentage of Subjects With 50% or Greater Reduction in Back Pain at 6 Months

Subjects experiencing 50% or more reduction in the intensity of the back pain.

Time frame:
6 Months
Reported as:
Count of participants · Participants
Percentage of Subjects With 50% or Greater Reduction in Back Pain at 6 Months
ParticipantsAll Subjects
Percentage of Subjects With 50% or Greater Reduction in Back Pain at 6 Months11
SecondaryPercentage of Subjects With 50% or Greater Reduction in Back Pain at 12 Months

Subjects experiencing 50% or more reduction in the intensity of the back pain.

Time frame:
12 Months
Reported as:
Count of participants · Participants
Percentage of Subjects With 50% or Greater Reduction in Back Pain at 12 Months
ParticipantsAll Subjects
Percentage of Subjects With 50% or Greater Reduction in Back Pain at 12 Months11

Adverse events

Collected over device related AE's and SAE's were reported from Informed Consent signature until the last follow-up visit (12 Months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Subjects0/20 (0%)0/20 (0%)5/20 (25%)
Most frequent other events
Most frequent other events
EventAll Subjects
Increased PainGeneral disorders5/20
Pain at pocketSkin and subcutaneous tissue disorders3/20

Baseline characteristics

Age, Customized
Age, Customized(years)All Subjects
Mean45 (22 to 71)
Sex: Female, Male
Sex: Female, Male(Participants)All Subjects
Female13
Male7
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Subjects
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White19
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)All Subjects
Netherlands20
08

Study locations

1 site
  • Rijnstate Ziekenhuis, Velp
    Velp, Arnhem 6883 AZ Velp, Netherlands
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 19, 2015

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02587637
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Oct 27, 2015
Start date
Oct 1, 2015
Primary completion
Dec 2017
Completion
Jan 30, 2018
Results posted
Sep 19, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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