Spinal Cord Stimulation Versus Instrumentation for FBSS

Low Back Pain Clinical Trial

— PROMISE  

Official title:

sPinal coRd stimulatiOn coMpared With Lumbar InStrumEntation for Low Back Pain After Previous Lumbar Decompression (PROMISE): a Prospective Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05466110
• Other study ID #: 22-0221
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Back Pain
• Failed Back Surgery Syndrome
• Low Back Pain
• Neuromodulation
• SCS
• Spinal Cord Stimulation
• Spinal Fusion

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