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

Primary Purpose

Failed Back Surgery Syndrome

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
subcutaneous nerve stimulation
Optimized Medical Management
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Failed Back Surgery Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hunter Pain Clinic
  • Greenslopes Private Hospital
  • Royal North Shore Hospital
  • Krankenhaus der Elisabethinen
  • Krankenhaus der Landes Kärnten
  • Krankenhaus der Barmherzigen Brüder
  • ZNA Middelheim
  • AZ Sint Jan
  • INDC Jolimont
  • Pijnkliniek Stedelijk Ziekenhuis
  • Clinique Mutualiste de la porte de l'Orient
  • Hospices civils de LYON
  • Clinique Brétéché
  • Fondation Rothschild
  • Hopital Purpan
  • Märkische Kliniken GmbH / Marienhospital Letmathe
  • Universitätsklinikum Jena
  • Universitätsklinikum Köln
  • Tel Aviv Medical Center
  • Rijnland Ziekenhuis
  • Albert Schweitzer Ziekenhuis
  • Amphia Ziekenhuis
  • Maasstad Ziekenhuis
  • Hospital Universitario del Rio Hortega
  • Hopital de Morges
  • The James Cook Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SQS plus OMM

OMM

Arm Description

subcutaneous nerve stimulation plus optimized medical management

optimized medical management

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 12, 2012
Last Updated
January 18, 2018
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT01711619
Brief Title
SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Challenges to recruit qualified participants
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SQS plus OMM
Arm Type
Experimental
Arm Description
subcutaneous nerve stimulation plus optimized medical management
Arm Title
OMM
Arm Type
Active Comparator
Arm Description
optimized medical management
Intervention Type
Device
Intervention Name(s)
subcutaneous nerve stimulation
Intervention Description
subcutaneous nerve stimulation plus optimized medical management
Intervention Type
Other
Intervention Name(s)
Optimized Medical Management
Intervention Description
Optimized medical management
Primary Outcome Measure Information:
Title
Effectiveness of Treatment on Reduction of Back Pain Intensity
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Average Change in Back Pain Intensity
Description
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.
Time Frame
6 and 9 months
Title
Back Pain Responder Rate (≥50%) at 6 Months
Description
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.
Time Frame
6 months
Title
Back Pain Responder Rate (≥30%) at 9 Months
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provides written Patient Informed Consent/Patient Information Sheet prior to study-related activities being conducted ≥ 18 years of age at time of informed consent Willing and available to attend visits as scheduled and to comply with the study protocol Willing and able to undergo assessments as part of the evaluation for eligibility and endpoints Willing and able to use the external neurostimulator, recharging equipment (if applicable), and patient programmer per the schedule required by the protocol 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 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)) Is an appropriate implant candidate for the SQS system Exclusion Criteria: Has been or is currently being treated with spinal cord stimulation, subcutaneous nerve stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system 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 Has a pain condition unrelated to FBSS that is severe enough to overshadow the FBSS pain in the opinion of the investigator Spinal instability or anatomic compression that requires further surgery Spinal fusion at more than 3 vertebral levels Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study Allergic or has shown hypersensitivity to any materials of the device system which come in contact with the body History of coagulation disorder or lupus erythematosus Involved in current litigation regarding back pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Eldabe, MD
Organizational Affiliation
The James Cook Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter Pain Clinic
City
Broadmeadow
ZIP/Postal Code
2292
Country
Australia
Facility Name
Greenslopes Private Hospital
City
Greenslopes
ZIP/Postal Code
4120
Country
Australia
Facility Name
Royal North Shore Hospital
City
St. Leonards
ZIP/Postal Code
2065
Country
Australia
Facility Name
Krankenhaus der Elisabethinen
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
Krankenhaus der Landes Kärnten
City
Klagenfurt am Wörthersee
ZIP/Postal Code
9020
Country
Austria
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Vienna
ZIP/Postal Code
1021
Country
Austria
Facility Name
ZNA Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
AZ Sint Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
INDC Jolimont
City
La Louviere
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Pijnkliniek Stedelijk Ziekenhuis
City
Roselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Clinique Mutualiste de la porte de l'Orient
City
Lorient
ZIP/Postal Code
56100
Country
France
Facility Name
Hospices civils de LYON
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Clinique Brétéché
City
Nantes
ZIP/Postal Code
44046
Country
France
Facility Name
Fondation Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Hopital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Märkische Kliniken GmbH / Marienhospital Letmathe
City
Iserlohn-Letmathe
ZIP/Postal Code
58642
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
ZIP/Postal Code
61999
Country
Israel
Facility Name
Rijnland Ziekenhuis
City
Alphen aan den Rijn
ZIP/Postal Code
2402
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
ZIP/Postal Code
3300
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Oosterhout-Breda
ZIP/Postal Code
3079
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
ZIP/Postal Code
3079
Country
Netherlands
Facility Name
Hospital Universitario del Rio Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Facility Name
Hopital de Morges
City
Morges
ZIP/Postal Code
1110
Country
Switzerland
Facility Name
The James Cook Hospital
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23799929
Citation
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.
Results Reference
derived

Learn more about this trial

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

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