Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome

Phase 4

Terminated

Conditions: Pain
Back Pain
Failed Back Surgery Syndrome

Interventions: Device: Precision Spinal Cord Stimulator
Procedure: Back Surgery

Registration Number: NCT01036529

Lead Sponsor: Boston Scientific Corporation

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 28

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Precision Spinal Cord Stimulator	Precision Spinal Cord Stimulator	Spinal Cord Stimulation
Back Surgery	Back Surgery	Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment	3, 6- and 12- months post-index procedure

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (18): Geisinger Medical Center
🇺🇸
Danville, Pennsylvania, United States
Orthopedic Research Foundation
🇺🇸
Savannah, Georgia, United States
The University of Illinois Medical Center
🇺🇸
Chicago, Illinois, United States
Pacific Medical Center
🇺🇸
Seattle, Washington, United States
Sinai Hospital of Baltimore
🇺🇸
Baltimore, Maryland, United States
Regina General Hospital
🇨🇦
Regina, Saskatchewan, Canada
St. Patrick Hospital
🇺🇸
Missoula, Montana, United States
Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States
University of California San Diego
🇺🇸
La Jolla, California, United States
Millenium Pain Center
🇺🇸
Bloomington, Illinois, United States
The Center for Clinical Research, LLC
🇺🇸
Winston-Salem, North Carolina, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Frenchay Hospital
🇬🇧
Bristol, United Kingdom
CHU de Nantes-Hopital Laennec
🇫🇷
Nantes Cedex, France
Hopital de Enfant-Jesus
🇨🇦
Quebec, Canada
Swedish Neuroscience Institute
🇺🇸
Seattle, Washington, United States
James Cook University Hospital
🇬🇧
Middlesbrough, United Kingdom
Scripps Clinic
🇺🇸
La Jolla, California, United States