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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Burst Spinal Cord Neurostimulation | Experimental | Burst spinal cord stimulation. When this fails, tonic stimulation targeting the DRG wil be applied |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurostimulation | Procedure | Spinal cord stimulation with burst modality for discogenic low back pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain severity | Pain severity, assessed by an 11 point (0-10) numerical pain rating scale 0=no pain, 10 very severe pain | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment satisfaction | Patient's Global Impression of Change, a 7-point Likert scale ( 1 =very much improved and 7 is very much worse | 1 year |
| Disability | Physical function will be assessed using the Oswestry Disability Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Willem Kallewaard, MD | Rijnstate Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate hospital Pain Management Centre Velp | Arnhem | Gelderland | 6883 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20825564 | Background | 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. | |
| 25879884 | Result | 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. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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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.
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| 1 year |
| Quality of Life utility score | EuroQol-5D-5L | 1 year |
| 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). | 1 year |
| Pain type | PainDETECT® questionnaire which is designed to differentiate between neuropathic and non-neuropathic pain. | 1 year |
| 37191612 | Derived | 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. |
| 36373868 | Derived | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |