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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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Low back pain affects people of all ages and has become the leading cause of living with disability worldwide. Patients, suffering from persistent pain after spinal surgery in the absence of any clear spinal pathology are defined of having a "failed back surgery syndrome (FBSS)" and treatment of FBSS remains a great controversy in the spinal community. Apart from conservative treatment, spinal fusion remains as therapeutic option. Furthermore, minimal invasive Neuromodulation techniques might be a promising alternative. Aim of this randomized interventional multi center study is to compare treatment success in FBSS patients with either spinal cord stimulation (SCS) or fusion surgery, 12 months after intervention according to the Oswestry Disability Index (ODI) and other scales and scores. Radiological and health economic outcome also will be analysed for thorough comparison of techniques. Additionally, the safety of the interventions needs to be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Stimulation Device | Experimental | The spinal cord stimulators WaveWriter AlphaTM (Boston Scientific) are designed to treat chronic back or leg pain by electrically stimulating the spinal cord. It is a well established worldwide licensed device. Percutaneous lead(-s) are implanted in the epidural space of the thoracic spine during the initial procedure. After discharge a trial phase is initiated and performed according to local preferences and standard of operations (SOPs). Patients are monitored for any complications and pain reduction. If a significant pain reduction (>50 % on the NRS scale for back pain) is achieved, the permanent implantable pulse generator (IPG) is implanted. Otherwise if the therapy remains non-beneficial throughout the trial phase, the leads will be explanted. Patients are allowed to crossover in the fusion group at any point of time. |
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| Control - Lumbar Fusion surgery | Active Comparator | The control group needs to represent the standard of care of current practice. Gold standard is lumbar fusion surgery [Resnik 2005]. Surgical instrumentation will be performed according to local preferences and SOPs. Safety and efficacy of these fusion techniques have been repeatedly proven |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation | Device | Epidural application of electrical current to the spinal cord |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry disability index / ODI | A patient reported outcome measure to rate pain and disability | 12 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Comparison of complication rates | 12 months after intervention |
| SF36 | Score to assess quality of life | 12 months after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ehab Shiban, MD | Contact | 0049 / (0)821 / 400-2251 | ehab.shiban@uk-augsburg.de | |
| Philipp Krauss, MD | Contact | 0049 / (0)821 / 400-2251 | philippemanuel.krauss@uk-augsburg.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Augsburg Department of Neurosurgery | Recruiting | Augsburg | Bavaria | 86156 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16028738 | Background | Resnick DK, Choudhri TF, Dailey AT, Groff MW, Khoo L, Matz PG, Mummaneni P, Watters WC 3rd, Wang J, Walters BC, Hadley MN; American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 10: fusion following decompression in patients with stenosis without spondylolisthesis. J Neurosurg Spine. 2005 Jun;2(6):686-91. doi: 10.3171/spi.2005.2.6.0686. | |
| 12973134 |
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| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
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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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| Spinal Fusion Surgery | Procedure | screw-rod system based spinal instrumentation |
|
| EuroQOL 5D | Score to assess quality of life | 12 months after intervention |
| hospital length of stay | Time measured in days, counting from the first day of hospitalization until the day of discharge of the hospitalization the surgical intervention was performed. If surgery is performed as staged procedure in two separate hospitalizations (SCS) both hospitalizations are counted as described above and days are summed up. | through study completion, an average of 2 years |
| Crossover rates | Rates of crossover to another therapy arm | 12 months after intervention |
| Pain medication | Amount of analgesics taken (drug, dose, mode of application) | 12 months after intervention |
| Background |
| Brox JI, Sorensen R, Friis A, Nygaard O, Indahl A, Keller A, Ingebrigtsen T, Eriksen HR, Holm I, Koller AK, Riise R, Reikeras O. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration. Spine (Phila Pa 1976). 2003 Sep 1;28(17):1913-21. doi: 10.1097/01.BRS.0000083234.62751.7A. |
| 11725230 | Background | Fritzell P, Hagg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4. doi: 10.1097/00007632-200112010-00002. |
| 18287602 | Background | Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136. |
| 26218762 | Background | Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, Amirdelfan K, Morgan DM, Brown LL, Yearwood TL, Bundschu R, Burton AW, Yang T, Benyamin R, Burgher AH. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015 Oct;123(4):851-60. doi: 10.1097/ALN.0000000000000774. |
| 11074683 | Background | Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017. |
| 34705106 | Background | Achttien RJ, Powell A, Zoulas K, Staal JB, Rushton A. Prognostic factors for outcome following lumbar spine fusion surgery: a systematic review and narrative synthesis. Eur Spine J. 2022 Mar;31(3):623-668. doi: 10.1007/s00586-021-07018-5. Epub 2021 Oct 27. |
| 37012023 | Derived | Krauss P, Motov S, Bonk MN, Prescher A, Scorzin J, Hajiabadi MM, Schulte DM, Sommer B, Seiz-Rosenhagen M, Ahmadi R, Maciaczyk J, Lehmberg J, Shiban E. sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE): a prospective multicentre RCT. BMJ Open. 2023 Apr 3;13(4):e067784. doi: 10.1136/bmjopen-2022-067784. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |