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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01711619




Registration number
NCT01711619
Ethics application status
Date submitted
12/07/2012
Date registered
22/10/2012
Date last updated
22/10/2018

Titles & IDs
Public title
SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients
Scientific 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)
Secondary ID [1] 0 0
1.02.7007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Failed Back Surgery Syndrome 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - subcutaneous nerve stimulation
Other interventions - Optimized Medical Management

Experimental: SQS plus OMM - subcutaneous nerve stimulation plus optimized medical management

Active Comparator: OMM - optimized medical management


Treatment: Devices: subcutaneous nerve stimulation
subcutaneous nerve stimulation plus optimized medical management

Other interventions: Optimized Medical Management
Optimized medical management

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
9 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 and 9 months
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
9 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Hunter Pain Clinic - Broadmeadow
Recruitment hospital [2] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment postcode(s) [3] 0 0
2065 - St. Leonards
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Klagenfurt am Wörthersee
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belgium
State/province [4] 0 0
Antwerp
Country [5] 0 0
Belgium
State/province [5] 0 0
Brugge
Country [6] 0 0
Belgium
State/province [6] 0 0
La Louviere
Country [7] 0 0
Belgium
State/province [7] 0 0
Roselare
Country [8] 0 0
France
State/province [8] 0 0
Lorient
Country [9] 0 0
France
State/province [9] 0 0
Lyon
Country [10] 0 0
France
State/province [10] 0 0
Nantes
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
France
State/province [12] 0 0
Toulouse
Country [13] 0 0
Germany
State/province [13] 0 0
Iserlohn-Letmathe
Country [14] 0 0
Germany
State/province [14] 0 0
Jena
Country [15] 0 0
Germany
State/province [15] 0 0
Köln
Country [16] 0 0
Israel
State/province [16] 0 0
Tel Aviv
Country [17] 0 0
Netherlands
State/province [17] 0 0
Alphen aan den Rijn
Country [18] 0 0
Netherlands
State/province [18] 0 0
Dordrecht
Country [19] 0 0
Netherlands
State/province [19] 0 0
Oosterhout-Breda
Country [20] 0 0
Netherlands
State/province [20] 0 0
Rotterdam
Country [21] 0 0
Spain
State/province [21] 0 0
Valladolid
Country [22] 0 0
Switzerland
State/province [22] 0 0
Morges
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Middlesbrough

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MedtronicNeuro
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT01711619
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Eldabe, MD
Address 0 0
The James Cook Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01711619