Failed Back Surgery SyndromePhase 4EvidenceNCT01036529
Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome
A Phase 4 study testing Precision Spinal Cord Stimulator and Back Surgery in people with Failed Back Surgery Syndrome and Pain, run by Boston Scientific Corporation at 18 sites in 4 countries.
Trial summary
The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Failed Back Surgery Syndrome, Pain, Back Pain
- What is being tested?
- Precision Spinal Cord Stimulator and Back Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Feb 2010to May 2013
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary pain type - neuropathic with concordant radicular or neurological findings
- Significant complaint of persistent or recurrent radicular leg pain, with or without low back pain
- One or more prior lumbosacral surgical procedures (no upper limit)
- At least 6 months duration of persistent or recurrent radicular leg pain, with or without low back pain
- Study candidates meet the criteria for a specific surgical intervention as recorded by a surgeon: pain refractory to conservative care, with concordant neurologic, tension, and/or mechanical signs and imaging findings of surgically remediable neural compression
- MRI or CT myelogram of the lumbar and thoracic spine (within 12 months prior to screening) that rules out pathology that might compromise SCS electrode placement or pathology, in addition to neural compression, that might contribute to the subject's pain
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- All study candidates must pass study site's routine psychological/psychiatric evaluation for SCS before randomization to SCS or reoperation
- At least 18 years of age
- Subject signs informed consent
Who cannot join
- Chief complaint of mechanical low back pain (e.g. pain that a recumbent position relieves completely)
- Pain intensity of always 10 on a 0-10 Numerical Rating Scale over the past 6 months based on subject recall
- Radiographic evidence of frank instability (grossly mobile spondylolisthesis or abnormal subluxation) requiring fusion, calcific arachnoiditis, or severe thoracic stenosis
- Radiographically demonstrated (by myelographic block or its MRI equivalent) critical cauda equinal compression
- A disabling or potentially disabling neurologic deficit (e.g., foot drop, neurogenic bladder) in the distribution of a nerve root or roots caused by surgically remediable compression
- A predominance of non-organic signs on physical exam
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- A concurrent clinically significant or disabling chronic pain problem or condition that is likely to confound evaluation of study endpoints (e.g., chronic migraine, significant arthrosis of the hip associated with groin pain as primary complaint)
- Significant substance abuse issues
- Major untreated psychiatric comorbidity
- Unresolved issues of secondary gain (e.g., litigation)
- Expected inability to report treatment outcome adequately
- Expected inability to operate SCS system
- Pregnancy (actual or planned)
- Life expectancy less than 3 years due to other serious medical condition(s)
- Active local or systemic infection
- Prior SCS procedure
- Presence of intrathecal drug pump
- Participation in another clinical study that would confound data of this study
- Occupational risk that would rule out SCS
- Medical or cardiac condition(s) or therapies, or foreseeable need for therapies or diagnostic tests (e.g., MRI), that preclude SCS and/or reoperation
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
United States13 sites
Sinai Hospital of Baltimore
Baltimore, Maryland, 21209
Millenium Pain Center
Bloomington, Illinois, 61701
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern Memorial Hospital
Chicago, Illinois, 60611
The University of Illinois Medical Center
Chicago, Illinois, 60612
Geisinger Medical Center
Danville, Pennsylvania, 17822
Scripps Clinic
La Jolla, California, 92037
University of California San Diego
La Jolla, California, 92037
St. Patrick Hospital
Missoula, Montana, 59802
Orthopedic Research Foundation
Savannah, Georgia, 31405
Swedish Neuroscience Institute
Seattle, Washington, 98122
Pacific Medical Center
Seattle, Washington, 98144
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103
Canada2 sites
Hopital de Enfant-Jesus
Québec, Quebec, G1J 1Z4
Regina General Hospital
Regina, Saskatchewan, S4P 0W5
United Kingdom2 sites
Frenchay Hospital
Bristol, BS16 1LE
James Cook University Hospital
Middlesbrough, TS4 3BW
About this study
Official title: Spinal Cord Stimulation With Precision® Spinal Cord Stimulation System Versus Reoperation for Failed Back Surgery Syndrome
The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). FBSS is defined as persistent or recurrent pain following one or more lumbosacral spine surgical procedures. Surgical procedures that can result in FBSS can be categorized as either decompression or decompression followed by fusion with or without instrumentation. The pain of FBSS is categorized as neuropathic, which involves pathological nerve activity and is commonly characterized by patients as shooting or burning and/or nociceptive, which signals actual or impending tissue damage or inflammation.
Read the detailed description
The co-primary study endpoints are proportion of subjects with ≥50% leg pain relief without crossover at 6 and at 24 months.
- Conditions
- Failed Back Surgery Syndrome, Pain, Back Pain
- Being tested
- Precision Spinal Cord Stimulator, Back Surgery
- Keywords
- Spinal Cord Stimulation, Decompression, Fusion with or without instrumentation, Discectomy, Laminectomy, Laminotomy, Foraminotomy
- Medical subject headings
- Failed Back Surgery Syndrome, Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Spinal Cord StimulatorDevice
Programming settings will be specific to the individual needs in accordance with the labeling
Back SurgeryProcedure or surgery
Also called Discectomy, Laminotomy, Laminectomy, Foraminotomy
Different types of back surgery may be performed
| Study group | Role | What they receive |
|---|---|---|
| Precision Spinal Cord Stimulator | Experimental | Spinal Cord Stimulation Receives: Device: Precision Spinal Cord Stimulator |
| Back Surgery | Active comparator | Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation Receives: Procedure: Back Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment
Measured: 3, 6- and 12- months post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startFeb 2010
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: Closed due to continued slow enrollment.
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.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard North, M.D., Principal investigator, The Sandra and Malcolm Berman Brain & Spine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036529
- Sponsor's protocol ID
- A2005
- Acronym
- Evidence
- Status last verified
- Nov 2020
- First submitted
- 17 Dec 2009
- Last updated
- 16 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Stimulation With Precision® Spinal Cord Stimulation System Versus Reoperation for Failed Back Surgery Syndrome
- ClinicalTrials.gov ID
- NCT01036529
- Acronym / sponsor ID
- Evidence / A2005
- Conditions
- Failed Back Surgery Syndrome, Pain, Back Pain
- Keywords
- Spinal Cord Stimulation, Decompression, Fusion with or without instrumentation, Discectomy, Laminectomy, Laminotomy, Foraminotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to continued slow enrollment.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Dec 2009 (estimated)
- Results
- Posted 28 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). FBSS is defined as persistent or recurrent pain following one or more lumbosacral spine surgical procedures. Surgical procedures that can result in FBSS can be categorized as either decompression or decompression followed by fusion with or without instrumentation. The pain of FBSS is categorized as neuropathic, which involves pathological nerve activity and is commonly characterized by patients as shooting or burning and/or nociceptive, which signals actual or impending tissue damage or inflammation.
Detailed description
The co-primary study endpoints are proportion of subjects with ≥50% leg pain relief without crossover at 6 and at 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precision Spinal Cord Stimulator | Experimental | Device: Precision Spinal Cord StimulatorSpinal Cord Stimulation |
| Back Surgery | Active comparator | Procedure: Back SurgeryDiscectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Primary pain type - neuropathic with concordant radicular or neurological findings
- Significant complaint of persistent or recurrent radicular leg pain, with or without low back pain
- One or more prior lumbosacral surgical procedures (no upper limit)
- At least 6 months duration of persistent or recurrent radicular leg pain, with or without low back pain
- Study candidates meet the criteria for a specific surgical intervention as recorded by a surgeon: pain refractory to conservative care, with concordant neurologic, tension, and/or mechanical signs and imaging findings of surgically remediable neural compression
Key exclusion criteria (20 listed)
- Chief complaint of mechanical low back pain (e.g. pain that a recumbent position relieves completely)
- Pain intensity of always 10 on a 0-10 Numerical Rating Scale over the past 6 months based on subject recall
- Radiographic evidence of frank instability (grossly mobile spondylolisthesis or abnormal subluxation) requiring fusion, calcific arachnoiditis, or severe thoracic stenosis
- Radiographically demonstrated (by myelographic block or its MRI equivalent) critical cauda equinal compression
- A disabling or potentially disabling neurologic deficit (e.g., foot drop, neurogenic bladder) in the distribution of a nerve root or roots caused by surgically remediable compression
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 |
|---|---|---|
| Precision Spinal Cord StimulatorProgramming settings will be specific to the individual needs in accordance with the labeling | Device | Precision Spinal Cord Stimulator |
| Back SurgeryAlso: Discectomy, Laminotomy, Laminectomy, ForaminotomyDifferent types of back surgery may be performed | Procedure or surgery | Back Surgery |
Primary outcome
Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment
Time frame: 3, 6- and 12- months post-index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Failed Back Surgery Syndrome
RecruitingObservational study
Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study
Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome
RecruitingPhase 4
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
Recruiting
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.
Richard North, M.D. principal investigator
The Sandra and Malcolm Berman Brain & Spine Institute
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Precision Spinal Cord Stimulator and Back Surgery in people with Failed Back Surgery Syndrome and Pain, run by Boston Scientific Corporation at 18 sites in 4 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 9 inclusion and 20 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 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada, United Kingdom, France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2013). 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?
Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment (time frame: 3, 6- and 12- months post-index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2020.