NCT05466110

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2022

Enrollment Period

1.6 years

First QC Date

April 25, 2022

Last Update Submit

April 13, 2023

Conditions

Failed Back Surgery SyndromeSCSNeuromodulationSpinal Cord StimulationSpinal FusionLow Back Pain

Outcome Measures

Primary Outcomes (1)

  • Oswestry disability index / ODI

    A patient reported outcome measure to rate pain and disability

    12 months after intervention

Secondary Outcomes (6)

  • Adverse events

    12 months after intervention

  • SF36

    12 months after intervention

  • EuroQOL 5D

    12 months after intervention

  • hospital length of stay

    through study completion, an average of 2 years

  • Crossover rates

    12 months after intervention

  • +1 more secondary outcomes

Study Arms (2)

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.

Device: Spinal Cord Stimulation

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

Procedure: Spinal Fusion Surgery

Interventions

Spinal Cord StimulationDEVICE

Epidural application of electrical current to the spinal cord

Also known as: SCS
Spinal Cord Stimulation Device
Spinal Fusion SurgeryPROCEDURE

screw-rod system based spinal instrumentation

Control - Lumbar Fusion surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Spinal stenosis resulting in spinal claudication or neurological deficits
  • Spinal Instability (\> 3 mm Motion on dynamic Lumbar X-rays)
  • Major psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Augsburg Department of Neurosurgery

Augsburg, Bavaria, 86156, Germany

RECRUITING

Related Publications (8)

  • 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.

    PMID: 16028738BACKGROUND

  • 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.

    PMID: 12973134BACKGROUND

  • 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.

    PMID: 11725230BACKGROUND

  • 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.

    PMID: 18287602BACKGROUND

  • 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.

    PMID: 26218762BACKGROUND

  • 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.

    PMID: 11074683BACKGROUND

  • 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.

    PMID: 34705106BACKGROUND

  • 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.

    PMID: 37012023DERIVED

MeSH Terms

Conditions

Failed Back Surgery SyndromeLow Back Pain

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Ehab Shiban, MD

CONTACT

0049 / (0)821 / 400-2251ehab.shiban@uk-augsburg.de

Philipp Krauss, MD

CONTACT

0049 / (0)821 / 400-2251philippemanuel.krauss@uk-augsburg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

July 20, 2022

Study Start

March 20, 2023

Primary Completion

November 1, 2024

Study Completion

May 1, 2025

Last Updated

April 14, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)