Spinal Cord Stimulation Versus Instrumentation for FBSS (PROMISE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Spinal Fusion; Neuromodulation; Failed Back Surgery Syndrome; Spinal Cord Stimulation; SCS
• Intervention / Treatment: Device: Spinal Cord Stimulation; Procedure: Spinal Fusion Surgery

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ehab Shiban, MD; Phone Number: 0049 / (0)821 / 400-2251; Email: ehab.shiban@uk-augsburg.de
• Study Contact Backup: Name: Philipp Krauss, MD; Phone Number: 0049 / (0)821 / 400-2251; Email: philippemanuel.krauss@uk-augsburg.de

Study Locations

• Germany
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Recruiting
      • University Hospital Augsburg Department of Neurosurgery
      • Contact: Ehab Shiban, MD; Email: Ehab.shiban@uk-augsburg.de
      • Contact: Philipp Krauss, MD; Email: philippemanuel.krauss@uk-augsburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal Cord Stimulation Device; 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.	Device: Spinal Cord Stimulation; Epidural application of electrical current to the spinal cord; Other Names: SCS
Active Comparator: Control - Lumbar Fusion surgery; 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	Procedure: Spinal Fusion Surgery; screw-rod system based spinal instrumentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry disability index / ODI	A patient reported outcome measure to rate pain and disability	12 months after intervention

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University Hospital Augsburg
• Collaborators: Boston Scientific Corporation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Anticipated): November 1, 2024
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: 22-0221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes