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Burst Neurostimulation for Discogenic Low Back Pain

Primary Purpose

Discogenic Pain, Low Back Pain

Status

Unknown status

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Neurostimulation

About this trial

This is an interventional treatment trial for Discogenic Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rijnstate hospital Pain Management Centre Velp

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Burst Spinal Cord Neurostimulation

Arm Description

Burst spinal cord stimulation. When this fails, tonic stimulation targeting the DRG wil be applied

Outcomes

Primary Outcome Measures

Pain severity

Pain severity, assessed by an 11 point (0-10) numerical pain rating scale 0=no pain, 10 very severe pain

Secondary Outcome Measures

Treatment satisfaction

Patient's Global Impression of Change, a 7-point Likert scale ( 1 =very much improved and 7 is very much worse

Disability

Physical function will be assessed using the Oswestry Disability Index

Quality of Life utility score

EuroQol-5D-5L

Safety; Serious and Adverse events

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

PainDETECT® questionnaire which is designed to differentiate between neuropathic and non-neuropathic pain.

Full Information

NCT ID

NCT03958604

First Posted

May 20, 2019

Last Updated

March 10, 2021

Sponsor

Rijnstate Hospital

Collaborators

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT03958604

Brief Title

Burst Neurostimulation for Discogenic Low Back Pain

Official Title

Prospective Post Market Pilot Study to Evaluate the Effectiveness of Burst Spinal Cord Stimulation in the Treatment of Discogenic Low Back Pain

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 28, 2019 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rijnstate Hospital

Collaborators

Abbott

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Discogenic Pain, Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Burst Spinal Cord Neurostimulation

Arm Type

Experimental

Arm Description

Burst spinal cord stimulation. When this fails, tonic stimulation targeting the DRG wil be applied

Intervention Type

Procedure

Intervention Name(s)

Neurostimulation

Other Intervention Name(s)

spinal cord burst stimulation, spinal cord stimulation, ProdigyTM Abbott Laboratories, ProclaimTM Abbott Laboratories

Intervention Description

Spinal cord stimulation with burst modality for discogenic low back pain

Primary Outcome Measure Information:

Title

Pain severity

Description

Pain severity, assessed by an 11 point (0-10) numerical pain rating scale 0=no pain, 10 very severe pain

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Treatment satisfaction

Description

Patient's Global Impression of Change, a 7-point Likert scale ( 1 =very much improved and 7 is very much worse

Time Frame

1 year

Title

Disability

Description

Physical function will be assessed using the Oswestry Disability Index

Time Frame

1 year

Title

Quality of Life utility score

Description

EuroQol-5D-5L

Time Frame

1 year

Title

Safety; Serious and Adverse events

Description

Time Frame

1 year

Title

Pain type

Description

PainDETECT® questionnaire which is designed to differentiate between neuropathic and non-neuropathic pain.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Willem Kallewaard, MD

Organizational Affiliation

Rijnstate Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rijnstate hospital Pain Management Centre Velp

City

Arnhem

State/Province

Gelderland

ZIP/Postal Code

6883 AZ

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20825564

Citation

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.

Results Reference

background

PubMed Identifier

25879884

Citation

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.

Results Reference

result

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Burst Neurostimulation for Discogenic Low Back Pain

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