SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients

Interventional, Prospective, Multicenter, Randomized, Parallel-arm Study to Compare the Effectiveness of Peripheral Nerve Stimulation (PNS) Utilizing a Subcutaneous Lead Implant Technique (SQS) Plus Optimized Medical Management (OMM) Versus OMM Alone in Patients Suffering From Back Pain Due to Failed Back Surgery Syndrome (FBSS)

The purpose of this study is to compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM) versus OMM alone in patients suffering from back pain due to Failed Back Surgery Syndrome (FBSS).

Study Overview

• Status: Terminated
• Conditions: Failed Back Surgery Syndrome
• Intervention / Treatment: Device: subcutaneous nerve stimulation; Other: Optimized Medical Management

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Broadmeadow, Australia, 2292
    • Hunter Pain Clinic
  • Greenslopes, Australia, 4120
    • Greenslopes Private Hospital
  • St. Leonards, Australia, 2065
    • Royal North Shore Hospital
• Austria
  • Graz, Austria, 8020
    • Krankenhaus der Elisabethinen
  • Klagenfurt am Wörthersee, Austria, 9020
    • Krankenhaus der Landes Kärnten
  • Vienna, Austria, 1021
    • Krankenhaus der Barmherzigen Brüder
• Belgium
  • Antwerp, Belgium, 2020
    • ZNA Middelheim
  • Brugge, Belgium, 8000
    • AZ Sint Jan
  • La Louviere, Belgium, 7100
    • INDC Jolimont
  • Roselare, Belgium, 8800
    • Pijnkliniek Stedelijk Ziekenhuis
• France
  • Lorient, France, 56100
    • Clinique Mutualiste de la Porte de l'Orient
  • Lyon, France, 69003
    • Hospices Civils de Lyon
  • Nantes, France, 44046
    • Clinique Breteche
  • Paris, France, 75019
    • Fondation Rothschild
  • Toulouse, France, 31059
    • Hopital Purpan
• Germany
  • Iserlohn-Letmathe, Germany, 58642
    • Märkische Kliniken GmbH / Marienhospital Letmathe
  • Jena, Germany, 07743
    • Universitätsklinikum Jena
  • Köln, Germany, 50937
    • Universitätsklinikum Köln
• Israel
  • Tel Aviv, Israel, 61999
    • Tel Aviv Medical Center
• Netherlands
  • Alphen aan den Rijn, Netherlands, 2402
    • Rijnland Ziekenhuis
  • Dordrecht, Netherlands, 3300
    • Albert Schweitzer Ziekenhuis
  • Oosterhout-Breda, Netherlands, 3079
    • Amphia ziekenhuis
  • Rotterdam, Netherlands, 3079
    • Maasstad Ziekenhuis
• Spain
  • Valladolid, Spain, 47012
    • Hospital Universitario del Río Hortega
• Switzerland
  • Morges, Switzerland, 1110
    • Hôpital de Morges
• United Kingdom
  • Middlesbrough, United Kingdom, TS4 3BW
    • The James Cook Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Provides written Patient Informed Consent/Patient Information Sheet prior to study-related activities being conducted
2. ≥ 18 years of age at time of informed consent
3. Willing and available to attend visits as scheduled and to comply with the study protocol
4. Willing and able to undergo assessments as part of the evaluation for eligibility and endpoints
5. Willing and able to use the external neurostimulator, recharging equipment (if applicable), and patient programmer per the schedule required by the protocol

6. Diagnosed with FBSS (i.e.):

   • Has had persistent pain for 6 months following most recent anatomically correct, successful surgery AND
   • There are no further therapeutic surgical options available as assessed by appropriate investigation
7. Back pain is considered intractable and has been adequately treated (failed an appropriate trial of at least 3 different classes of back pain treatments (pharmaceutical and/or non-pharmaceutical))
8. Is an appropriate implant candidate for the SQS system

Exclusion Criteria:

1. Has been or is currently being treated with spinal cord stimulation, subcutaneous nerve stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
2. Evidence of an active disruptive psychiatric disorder that is significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome, as determined by the investigator
3. Has a pain condition unrelated to FBSS that is severe enough to overshadow the FBSS pain in the opinion of the investigator
4. Spinal instability or anatomic compression that requires further surgery
5. Spinal fusion at more than 3 vertebral levels
6. Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study
7. Allergic or has shown hypersensitivity to any materials of the device system which come in contact with the body
8. History of coagulation disorder or lupus erythematosus
9. Involved in current litigation regarding back pain

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: SQS plus OMM; subcutaneous nerve stimulation plus optimized medical management	Device: subcutaneous nerve stimulation; subcutaneous nerve stimulation plus optimized medical management; Other: Optimized Medical Management; Optimized medical management
Active Comparator: OMM; optimized medical management	Other: Optimized Medical Management; Optimized medical management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of Treatment on Reduction of Back Pain Intensity	Percentage of participants who responded to the treatment, where response was defined as ≥ 50% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 9-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change in Back Pain Intensity	Average change in back pain intensity from baseline to the 6 and 9-month follow-up visits. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable. A reduction in average pain score is indicated by a negative number.	6 and 9 months
Back Pain Responder Rate (≥50%) at 6 Months	Percentage of participants who responded to the treatment, where response was defined as ≥ 50% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 6-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable.	6 months
Back Pain Responder Rate (≥30%) at 9 Months	Percentage of participants who responded to the treatment, where response was defined as ≥ 30% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 9-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable.	9 months

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Principal Investigator: Sam Eldabe, MD, The James Cook Hospital

Publications and helpful links

General Publications

• Eldabe S, Kern M, Peul W, Green C, Winterfeldt K, Taylor RS. Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): study protocol for a multicenter randomized controlled trial. Trials. 2013 Jun 25;14:189. doi: 10.1186/1745-6215-14-189.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: July 12, 2012
• First Submitted That Met QC Criteria: October 18, 2012
• First Posted (Estimate): October 22, 2012

Study Record Updates

• Last Update Posted (Actual): October 22, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease; Back Pain; Syndrome; Failed Back Surgery Syndrome
• Other Study ID Numbers: 1.02.7007