Clinical trial NCT01711619: 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
Overall status: TERMINATED
Phase: NA
Conditions: Failed Back Surgery Syndrome
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2012-10-22
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness of Treatment on Reduction of Back Pain Intensity
timeFrame: 9 months
Secondary outcomes:
measure: Average Change in Back Pain Intensity
timeFrame: 6 and 9 months
measure: Back Pain Responder Rate (≥50%) at 6 Months
timeFrame: 6 months
measure: Back Pain Responder Rate (≥30%) at 9 Months
timeFrame: 9 months
Other outcomes:
Locations:
city: Broadmeadow
country: Australia
facility: Hunter Pain Clinic
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
city: Graz
country: Austria
facility: Krankenhaus der Elisabethinen
city: Klagenfurt am Wörthersee
country: Austria
facility: Krankenhaus der Landes Kärnten
city: Vienna
country: Austria
facility: Krankenhaus der Barmherzigen Brüder
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: La Louviere
country: Belgium
facility: INDC Jolimont
city: Roselare
country: Belgium
facility: Pijnkliniek Stedelijk Ziekenhuis
city: Lorient
country: France
facility: Clinique Mutualiste de la porte de l'Orient
city: Lyon
country: France
facility: Hospices civils de LYON
city: Nantes
country: France
facility: Clinique Brétéché
city: Paris
country: France
facility: Fondation Rothschild
city: Toulouse
country: France
facility: Hopital Purpan
city: Iserlohn-Letmathe
country: Germany
facility: Märkische Kliniken GmbH / Marienhospital Letmathe
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Alphen aan den Rijn
country: Netherlands
facility: Rijnland Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Oosterhout-Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Valladolid
country: Spain
facility: Hospital Universitario del Rio Hortega
city: Morges
country: Switzerland
facility: Hopital de Morges
city: Middlesbrough
country: United Kingdom
facility: The James Cook Hospital
Study officials:
affiliation: The James Cook Hospital
name: Sam Eldabe, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.