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出境医 / 临床实验 / Burst Neurostimulation for Discogenic Low Back Pain

Burst Neurostimulation for Discogenic Low Back Pain

Study Description
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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
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 : December 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
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Netherlands
Rijnstate hospital Pain Management Centre Velp
Arnhem, Gelderland, Netherlands, 6883 AZ
Sponsors and Collaborators
Rijnstate Hospital
Abbott
Investigators
Layout table for investigator information
Principal Investigator: Jan Willem Kallewaard, MD Rijnstate Hospital
Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date March 11, 2021
Actual Study Start Date  ICMJE May 28, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • 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
  • Disability [ Time Frame: 1 year ]
    Physical function will be assessed using the Oswestry Disability Index
  • Quality of Life utility score [ Time Frame: 1 year ]
    EuroQol-5D-5L
  • 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).
  • Pain type [ Time Frame: 1 year ]
    PainDETECT® questionnaire which is designed to differentiate between neuropathic and non-neuropathic pain.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • 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
  • Disability [ Time Frame: 1 year ]
    Physical function will be assessed using the Oswestry Disability Index
  • Quality of Life utility score [ Time Frame: 1 year ]
    EQ-5D-5L
  • 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).
  • Pain type [ Time Frame: 1 year ]
    PainDETECT® questionnaire which is designed to differentiate between neuropathic and non-neuropathic pain.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Burst Neurostimulation for Discogenic Low Back Pain
Official Title  ICMJE Prospective Post Market Pilot Study to Evaluate the Effectiveness of Burst Spinal Cord Stimulation in the Treatment of Discogenic Low Back Pain
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE
  • Discogenic Pain
  • Low Back Pain
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Burst Spinal Cord Neurostimulation
Burst spinal cord stimulation. When this fails, tonic stimulation targeting the DRG wil be applied
Intervention: Procedure: Neurostimulation
Publications *
  • Kallewaard JW, Terheggen MA, Groen GJ, Sluijter ME, Derby R, Kapural L, Mekhail N, van Kleef M. 15. Discogenic low back pain. Pain Pract. 2010 Nov-Dec;10(6):560-79. doi: 10.1111/j.1533-2500.2010.00408.x. Epub 2010 Sep 6. Review.
  • Courtney P, Espinet A, Mitchell B, Russo M, Muir A, Verrills P, Davis K. Improved Pain Relief With Burst Spinal Cord Stimulation for Two Weeks in Patients Using Tonic Stimulation: Results From a Small Clinical Study. Neuromodulation. 2015 Jul;18(5):361-6. doi: 10.1111/ner.12294. Epub 2015 Apr 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 10, 2021) 		16
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2019) 		20
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958604
Other Study ID Numbers  ICMJE NL 67172.091.18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rijnstate Hospital
Study Sponsor  ICMJE Rijnstate Hospital
Collaborators  ICMJE Abbott
Investigators  ICMJE
Principal Investigator: Jan Willem Kallewaard, MD Rijnstate Hospital
PRS Account Rijnstate Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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