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

Not Applicable

Terminated

Interventions: Device: subcutaneous nerve stimulation
Other: Optimized Medical Management

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
SQS plus OMM	subcutaneous nerve stimulation	subcutaneous nerve stimulation plus optimized medical management
OMM	Optimized Medical Management	optimized medical management
SQS plus OMM	Optimized Medical Management	subcutaneous nerve stimulation plus optimized medical management

Primary Outcome Measures

Name	Time	Method
Effectiveness of Treatment on Reduction of Back Pain Intensity	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.

Secondary Outcome Measures

Name	Time	Method
Average Change in Back Pain Intensity	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.
Back Pain Responder Rate (≥50%) at 6 Months	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	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.

Locations (26): Hunter Pain Clinic
🇦🇺
Broadmeadow, Australia
Greenslopes Private Hospital
🇦🇺
Greenslopes, Australia
Royal North Shore Hospital
🇦🇺
St. Leonards, Australia
ZNA Middelheim
🇧🇪
Antwerp, Belgium
AZ Sint Jan
🇧🇪
Brugge, Belgium
INDC Jolimont
🇧🇪
La Louviere, Belgium
Pijnkliniek Stedelijk Ziekenhuis
🇧🇪
Roselare, Belgium
Clinique Mutualiste de la porte de l'Orient
🇫🇷
Lorient, France
Clinique Brétéché
🇫🇷
Nantes, France
Hopital Purpan
🇫🇷
Toulouse, France
Märkische Kliniken GmbH / Marienhospital Letmathe
🇩🇪
Iserlohn-Letmathe, Germany
Fondation Rothschild
🇫🇷
Paris, France
Universitätsklinikum Köln
🇩🇪
Köln, Germany
Universitätsklinikum Jena
🇩🇪
Jena, Germany
Amphia Ziekenhuis
🇳🇱
Oosterhout-Breda, Netherlands
Maasstad Ziekenhuis
🇳🇱
Rotterdam, Netherlands
Tel Aviv Medical Center
🇮🇱
Tel Aviv, Israel
Albert Schweitzer Ziekenhuis
🇳🇱
Dordrecht, Netherlands
Rijnland Ziekenhuis
🇳🇱
Alphen aan den Rijn, Netherlands
Hospital Universitario del Rio Hortega
🇪🇸
Valladolid, Spain
Krankenhaus der Elisabethinen
🇦🇹
Graz, Austria
Krankenhaus der Barmherzigen Brüder
🇦🇹
Vienna, Austria
Krankenhaus der Landes Kärnten
🇦🇹
Klagenfurt am Wörthersee, Austria
Hopital de Morges
🇨🇭
Morges, Switzerland
Hospices civils de LYON
🇫🇷
Lyon, France
The James Cook Hospital
🇬🇧
Middlesbrough, United Kingdom