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

NCT01711619 | Terminated Results DMC

• 1 other identifier: 1.02.7007
• Study Type: interventional
• Target: 162
• Locations: 9 countries
• Sites: 23

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).

Conditions

Failed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Average Change in Back Pain Intensity

  6 and 9 months

• Back Pain Responder Rate (≥50%) at 6 Months

  6 months

• Back Pain Responder Rate (≥30%) at 9 Months

  9 months

Study Arms (2)

SQS plus OMM

EXPERIMENTAL

subcutaneous nerve stimulation plus optimized medical management

Device: subcutaneous nerve stimulation; Other: Optimized Medical Management

OMM

ACTIVE COMPARATOR

optimized medical management

Other: Optimized Medical Management

Interventions

subcutaneous nerve stimulation DEVICE

subcutaneous nerve stimulation plus optimized medical management

SQS plus OMM

Optimized Medical Management OTHER

Optimized medical management

OMM; SQS plus OMM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (26)

Hunter Pain Clinic

Broadmeadow, 2292, Australia

Location

Greenslopes Private Hospital

Greenslopes, 4120, Australia

Location

Royal North Shore Hospital

St Leonards, 2065, Australia

Location

Krankenhaus der Elisabethinen

Graz, 8020, Austria

Location

Krankenhaus der Landes Kärnten

Klagenfurt, 9020, Austria

Location

Krankenhaus der Barmherzigen Brüder

Vienna, 1021, Austria

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

AZ Sint Jan

Bruges, 8000, Belgium

Location

INDC Jolimont

La Louvière, 7100, Belgium

Location

Pijnkliniek Stedelijk Ziekenhuis

Roeselare, 8800, Belgium

Location

Clinique Mutualiste de la porte de l'Orient

Lorient, 56100, France

Location

Hospices civils de LYON

Lyon, 69003, France

Location

Clinique Brétéché

Nantes, 44046, France

Location

Fondation Rothschild

Paris, 75019, France

Location

Hopital Purpan

Toulouse, 31059, France

Location

Universitätsklinikum Köln

Cologne, 50937, Germany

Location

Märkische Kliniken GmbH / Marienhospital Letmathe

Iserlohn-Letmathe, 58642, Germany

Location

Universitätsklinikum Jena

Jena, 07743, Germany

Location

Tel Aviv Medical Center

Tel Aviv, 61999, Israel

Location

Rijnland Ziekenhuis

Alphen aan den Rijn, 2402, Netherlands

Location

Albert Schweitzer Ziekenhuis

Dordrecht, 3300, Netherlands

Location

Amphia Ziekenhuis

Oosterhout-Breda, 3079, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, 3079, Netherlands

Location

Hospital Universitario del Rio Hortega

Valladolid, 47012, Spain

Location

Hopital de Morges

Morges, 1110, Switzerland

Location

The James Cook Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23799929 DERIVED

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Global Clinical Study Manager
• Organization: Medtronic

medtronicneurotrials@medtronic.com

Study Officials

• Sam Eldabe, MD

  The James Cook Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: October 22, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 22, 2018
• Results First Posted: October 22, 2018

Record last verified: 2018-01

Locations

GB (1); ES (1); NL (4); FR (5); IL (1); AU (3); DE (3); CH (1); BE (4)