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Completed

NCT Number: NCT02587637

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate Ziekenhuis, Velp

Velp, Arnhem, 6883 AZ Velp, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilised in the study centre
  • Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. Percentage of Subjects With 30% or Greater Reduction in Back Pain at 6 Months

    Time frame: 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.

  2. Percentage of Subjects With 30% or Greater Reduction in Back Pain at 12 Months

    Time frame: 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 outcomes

  1. Percentage of Patients With Improved Global Impression of Change at 6 Months

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 6 Months

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

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

    Time frame: 12 Months

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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Oct 27, 2015
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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