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Discogenic PainNCT03958604

Burst Neurostimulation for Discogenic Low Back Pain

A study testing Neurostimulation in people with Discogenic Pain and Low Back Pain, run by Rijnstate Hospital at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Discogenic Pain, Low Back Pain
What is being tested?
Neurostimulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteNetherlands
Study dates
28 May 2019to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Rijnstate hospital Pain Management Centre Velp

    Arnhem, Gelderland, 6883 AZ

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
Neurostimulation
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeurostimulationProcedure or surgery

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

    Spinal cord stimulation with burst modality for discogenic low back pain

Study groups in NCT03958604
Study groupRoleWhat they receive
Burst Spinal Cord NeurostimulationExperimentalBurst spinal cord stimulation. When this fails, tonic stimulation targeting the DRG wil be applied
Receives: Procedure: Neurostimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain severity

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

    Measured: 1 year

Secondary outcomes (5)

  1. Treatment satisfaction

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

    Measured: 1 year

  2. Disability

    Physical function will be assessed using the Oswestry Disability Index

    Measured: 1 year

  3. Quality of Life utility score

    EuroQol-5D-5L

    Measured: 1 year

  4. 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).

    Measured: 1 year

  5. Pain type

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2019
  2. Study start28 May 2019
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03958604
Sponsor's protocol ID
NL 67172.091.18
Status last verified
Dec 2021
First submitted
20 May 2019
Last updated
19 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 20825564

  • 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.

    PubMed 25879884

  • Mons MR, Chapman KB, Terwiel C, Joosten EA, Kallewaard JW. Burst Spinal Cord Stimulation as Compared With L2 Dorsal Root Ganglion Stimulation in Pain Relief for Nonoperated Discogenic Low Back Pain: Analysis of Two Prospective Studies. Neuromodulation. 2024 Jan;27(1):172-177. doi: 10.1016/j.neurom.2023.04.464. Epub 2023 May 16.

    PubMed 37191612

  • Mons MR, Chapman KB, Terwiel C, Joosten EA, Kallewaard JW. A prospective study of BurstDR spinal cord stimulation for non-operated discogenic low back pain. Pain Pract. 2023 Mar;23(3):234-241. doi: 10.1111/papr.13181. Epub 2022 Nov 23.

    PubMed 36373868

Questions about this trial

What is this clinical trial studying?

A study testing Neurostimulation in people with Discogenic Pain and Low Back Pain, run by Rijnstate Hospital at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain severity (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03958604, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.

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