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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05466110
Other study ID # 22-0221
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 20, 2023
Est. completion date May 2025

Study information

Verified date April 2022
Source University Hospital Augsburg
Contact Ehab Shiban, MD
Phone 0049 / (0)821 / 400-2251
Email ehab.shiban@uk-augsburg.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 84
Est. completion date May 2025
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age =18 years - Symptomatic degenerative disc disease with LBP as a predominant symptom for at least 6 months following pervious surgery for disc herniation - ODI score at least 21 - Correctly signed informed consent form Exclusion Criteria: - Spinal stenosis resulting in spinal claudication or neurological deficits - Spinal Instability (> 3 mm Motion on dynamic Lumbar X-rays) - Major psychiatric disorder

Study Design


Intervention

Device:
Spinal Cord Stimulation
Epidural application of electrical current to the spinal cord
Procedure:
Spinal Fusion Surgery
screw-rod system based spinal instrumentation

Locations

Country Name City State
Germany University Hospital Augsburg Department of Neurosurgery Augsburg Bavaria

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Augsburg Boston Scientific Corporation

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Oswestry disability index / ODI A patient reported outcome measure to rate pain and disability 12 months after intervention
Secondary Adverse events Comparison of complication rates 12 months after intervention
Secondary SF36 Score to assess quality of life 12 months after intervention
Secondary EuroQOL 5D Score to assess quality of life 12 months after intervention
Secondary 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
Secondary Crossover rates Rates of crossover to another therapy arm 12 months after intervention
Secondary Pain medication Amount of analgesics taken (drug, dose, mode of application) 12 months after intervention
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