Clinical trial NCT01036529: Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome
Official title: Spinal Cord Stimulation With Precision® Spinal Cord Stimulation System Versus Reoperation for Failed Back Surgery Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Failed Back Surgery Syndrome
Pain
Back Pain
Keywords: Spinal Cord Stimulation
Decompression
Fusion with or without instrumentation
Discectomy
Laminectomy
Laminotomy
Foraminotomy
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2009-12-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment
timeFrame: 3, 6- and 12- months post-index procedure
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Savannah
country: United States
facility: Orthopedic Research Foundation
state: Georgia
city: Bloomington
country: United States
facility: Millenium Pain Center
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: The University of Illinois Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Missoula
country: United States
facility: St. Patrick Hospital
state: Montana
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
city: Seattle
country: United States
facility: Pacific Medical Center
state: Washington
city: Regina
country: Canada
facility: Regina General Hospital
state: Saskatchewan
city: Quebec
country: Canada
facility: Hopital de Enfant-Jesus
city: Nantes Cedex
country: France
facility: CHU de Nantes-Hopital Laennec
city: Bristol
country: United Kingdom
facility: Frenchay Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
Study officials:
affiliation: The Sandra and Malcolm Berman Brain & Spine Institute
name: Richard North, M.D.
role: PRINCIPAL_INVESTIGATOR
References: