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Burst Neurostimulation for Discogenic Low Back Pain

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ClinicalTrials.gov Identifier: NCT03958604
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Rijnstate Hospital

Brief Summary:
The purpose of this prospective post market pilot study is to evaluate the effect of Burst Spinal Cord Stimulation(B-SCS) 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 SCS as routinely utilized in the study centers. Results from this pilot study will inform current clinical practice and future comparative studies in this specific population. Eligible subjects for B-SCS will be asked to participate in this study. If they decide to participate, they will be treated with the Prodigy TM and Proclaim TM (Abbott Laboratories) SCS system and prospectively followed for 12 months following implantation.

Condition or disease Intervention/treatment Phase
Discogenic Pain Low Back Pain Procedure: Neurostimulation Not Applicable

Detailed Description:
This is a prospective, single-arm, single-center, post-market, pilot study to collect data on back pain relief, subject satisfaction, quality of life, physical functioning and safety. Chronic discogenic pain(CDP) suffering patients will be followed for 12 months with follow-up visits at 3, 6, and 12 months. In line with standard practice the system will be implanted in two stages. The first stage is the Trial Burst spinal cord Neurostimulation (TBNS) phase during which epidural leads are implanted and temporarily tunnelled to an external trial stimulation device. Subjects will then utilize the temporary system for a period in line with usual practice (typically 10-14 days). If, at the end of this TBNS phase a reduction of ≥50% is achieved the device will be permanently implanted (the second stage) and subjects will be followed-up during 12 months. Patients who do not have at least 50% pain relief during TBNS will receive a Trial Tonic Neurostimulator(TTNS) targeting the dorsal root ganglion(DRG). Similarly, these patients will be followed-up during 12 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Burst neurostimulation for discogenic low back pain. If this fails to provide pain relief of at least 50%, tonic stimulation targeting the DRG will be the second treatment potential. Follow-up during one year.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Post Market Pilot Study to Evaluate the Effectiveness of Burst Spinal Cord Stimulation in the Treatment of Discogenic Low Back Pain
Actual Study Start Date : May 28, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Burst Spinal Cord Neurostimulation
Burst spinal cord stimulation. When this fails, tonic stimulation targeting the DRG wil be applied
Procedure: Neurostimulation
Spinal cord stimulation with burst modality for discogenic low back pain
Other Names:
  • spinal cord burst stimulation
  • spinal cord stimulation
  • ProdigyTM Abbott Laboratories
  • ProclaimTM Abbott Laboratories




Primary Outcome Measures :
  1. Pain severity [ Time Frame: 1 year ]
    Pain severity, assessed by an 11 point (0-10) numerical pain rating scale 0=no pain, 10 very severe pain


Secondary Outcome Measures :
  1. Treatment satisfaction [ Time Frame: 1 year ]
    Patient's Global Impression of Change, a 7-point Likert scale ( 1 =very much improved and 7 is very much worse

  2. Disability [ Time Frame: 1 year ]
    Physical function will be assessed using the Oswestry Disability Index

  3. Quality of Life utility score [ Time Frame: 1 year ]
    EuroQol-5D-5L

  4. Safety; Serious and Adverse events [ Time Frame: 1 year ]
    Safety will be monitored by the collection and reporting of device related adverse events, device related serious adverse events and any unanticipated serious adverse events (regardless of device relatedness).

  5. Pain type [ Time Frame: 1 year ]
    PainDETECT® questionnaire which is designed to differentiate between neuropathic and non-neuropathic pain.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • Subject has a negative test block of facet joints in the sacroiliac joint.
  • Neurologic exam without marked motor deficit.
  • Definite/Highly Probable/Discogenic Pain as confirmed by provocative discography according to International Association for the Study of Pain (IASP/ISIS) guidelines
  • Low Back Pain intensity should be 6 or higher measured on a Numeric Pain Rating Scale(NPRS) at baseline
  • Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center
  • 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
  • Body Mass Index ≥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 Internal Cardioverter Defibrillator(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 of ComputoTomography (CT)/Magnetic Resonance Imaging(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(SCS) therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958604


Contacts
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Contact: Rijnstate Arnhem Kallewaard t +31(0)88-005 8758 jkallewaard@rijnstate.nl
Contact: José Geurts, Drs t +31(0)88-005 8758 jwjmgeurts@rijnstate.nl

Locations
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Netherlands
Rijnstate hospital Pain Management Centre Velp Recruiting
Arnhem, Gelderland, Netherlands, 6883 AZ
Contact: Jan Willem Kallewaard, MD    0031 (0)88 005 5311      
Contact: Caro Edelbroek, MSc         
Sponsors and Collaborators
Rijnstate Hospital
Abbott
Investigators
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Principal Investigator: Jan Willem Kallewaard, MD Rijnstate Hospital

Publications of Results:
Other Publications:
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Responsible Party: Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT03958604     History of Changes
Other Study ID Numbers: NL 67172.091.18
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms