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

January 18, 2018 updated by: MedtronicNeuro

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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 Brétéché
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effectiveness of Treatment on Reduction of Back Pain Intensity
Time Frame: 9 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 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Average Change in Back Pain Intensity
Time Frame: 6 and 9 months
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
Time Frame: 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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MedtronicNeuro

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sam Eldabe, MD, The James Cook Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1.02.7007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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