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

Failed Back Surgery Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01711619
• Other study ID #: 1.02.7007
• Status: Terminated
• Phase: N/A
• Start date: November 2012
• Est. completion date: February 2016

Study information

• Verified date: January 2018
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 162
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Syndrome

Intervention

Device:
• subcutaneous nerve stimulation
subcutaneous nerve stimulation plus optimized medical management

Other:
• Optimized Medical Management
Optimized medical management

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  France,  Germany,  Israel,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 and 9 months
Secondary	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.	6 months
Secondary	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.	9 months