Failed Back Surgery SyndromeNCT01711619
SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients
A study testing subcutaneous nerve stimulation and Optimized Medical Management in people with Failed Back Surgery Syndrome, run by MedtronicNeuro at 26 sites in 10 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- subcutaneous nerve stimulation and Optimized Medical Management
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 26 sitesin 10 countries
- Study dates
- Nov 2012to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.):
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- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
26 sites in 10 countries.
26 sites in 10 countries
France5 sites
Clinique Mutualiste de la porte de l'Orient
Lorient, 56100
Hospices civils de LYON
Lyon, 69003
Clinique Brétéché
Nantes, 44046
Fondation Rothschild
Paris, 75019
Hopital Purpan
Toulouse, 31059
Belgium4 sites
ZNA Middelheim
Antwerp, 2020
AZ Sint Jan
Bruges, 8000
INDC Jolimont
La Louvière, 7100
Pijnkliniek Stedelijk Ziekenhuis
Roeselare, 8800
Netherlands4 sites
Rijnland Ziekenhuis
Alphen aan den Rijn, 2402
Albert Schweitzer Ziekenhuis
Dordrecht, 3300
Amphia Ziekenhuis
Oosterhout-Breda, 3079
Maasstad Ziekenhuis
Rotterdam, 3079
Australia3 sites
Hunter Pain Clinic
Broadmeadow, 2292
Greenslopes Private Hospital
Greenslopes, 4120
Royal North Shore Hospital
St Leonards, 2065
Austria3 sites
Krankenhaus der Elisabethinen
Graz, 8020
Krankenhaus der Landes Kärnten
Klagenfurt, 9020
Krankenhaus der Barmherzigen Brüder
Vienna, 1021
Germany3 sites
Universitätsklinikum Köln
Cologne, 50937
Märkische Kliniken GmbH / Marienhospital Letmathe
Iserlohn-Letmathe, 58642
Universitätsklinikum Jena
Jena, 07743
About this study
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)
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
- Being tested
- subcutaneous nerve stimulation, Optimized Medical Management
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous nerve stimulationDevice
subcutaneous nerve stimulation plus optimized medical management
Optimized Medical ManagementOther
Optimized medical management
| Study group | Role | What they receive |
|---|---|---|
| SQS plus OMM | Experimental | subcutaneous nerve stimulation plus optimized medical management Receives: Device: subcutaneous nerve stimulation; Other: Optimized Medical Management |
| OMM | Active comparator | optimized medical management Receives: Other: Optimized Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (3)
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.
Measured: 6 and 9 months
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.
Measured: 6 months
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Challenges to recruit qualified participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sam Eldabe, MD, Principal investigator, The James Cook Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711619
- Sponsor's protocol ID
- 1.02.7007
- Status last verified
- Jan 2018
- First submitted
- 12 Jul 2012
- Last updated
- 22 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 23799929
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01711619
- Acronym / sponsor ID
- 1.02.7007
- Conditions
- Failed Back Surgery Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Challenges to recruit qualified participants
- Enrolment
- 162 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Posted 22 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SQS plus OMM | Experimental | Device: subcutaneous nerve stimulation, Other: Optimized Medical Managementsubcutaneous nerve stimulation plus optimized medical management |
| OMM | Active comparator | Other: Optimized Medical Managementoptimized medical management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subcutaneous nerve stimulationsubcutaneous nerve stimulation plus optimized medical management | Device | SQS plus OMM |
| Optimized Medical ManagementOptimized medical management | Other | OMM, SQS plus OMM |
Primary outcome
Effectiveness of Treatment on Reduction of Back Pain Intensity
Time frame: 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.
3 secondary outcomes
Average Change in Back Pain Intensity
Time frame: 6 and 9 months
Back Pain Responder Rate (≥50%) at 6 Months
Time frame: 6 months
Back Pain Responder Rate (≥30%) at 9 Months
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23799929Eldabe 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.
Related trials for Failed Back Surgery Syndrome
RecruitingObservational study
Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study
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Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Iliac Pain (CORTisone Injection Spine Study)
Back Pain Lower Back, Neck Pain
Not yet recruitingObservational study
SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Chronic Low Back Pain
Active, not recruiting
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
Failed Back Surgery Syndrome, Degeneration Lumbar Spine
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Improvement of Gait by Spinal Stimulation in Patients With Postoperative Chronic Lumbosciatalgia: Pilot Study (GaitStim)
Failed Back Surgery Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Eldabe, MD principal investigator
The James Cook Hospital
26 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subcutaneous nerve stimulation and Optimized Medical Management in people with Failed Back Surgery Syndrome, run by MedtronicNeuro at 26 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France, Belgium, Netherlands, Australia, Austria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Treatment on Reduction of Back Pain Intensity (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01711619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.