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

This study has been terminated.
(Closed due to continued slow enrollment.)
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01036529
First received: December 17, 2009
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Failed Back Surgery Syndrome
Pain
Back Pain
Device: Precision Spinal Cord Stimulator
Procedure: Back Surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Spinal Cord Stimulation With Precision® Spinal Cord Stimulation System Versus Reoperation for Failed Back Surgery Syndrome

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: February 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Precision Spinal Cord Stimulator
Spinal Cord Stimulation
Device: Precision Spinal Cord Stimulator
Programming settings will be specific to the individual needs in accordance with the labeling
Other Name: Precision Spinal Cord Stimulator
Active Comparator: Back Surgery
Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
Procedure: Back Surgery
Different types of back surgery may be performed
Other Names:
  • Discectomy
  • Laminotomy
  • Laminectomy
  • Foraminotomy
  • Foraminectomy
  • Fusion with or without instrumentation

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01036529

Locations
United States, California
University of California San Diego
La Jolla, California, United States, 92037
Scripps Clinic
La Jolla, California, United States, 92037
United States, Georgia
Orthopedic Research Foundation
Savannah, Georgia, United States, 31405
United States, Illinois
Millenium Pain Center
Bloomington, Illinois, United States, 61701
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
The University of Illinois Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21209
United States, Montana
St. Patrick Hospital
Missoula, Montana, United States, 59802
United States, North Carolina
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Washington
Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
Pacific Medical Center
Seattle, Washington, United States, 98144
Canada, Saskatchewan
Regina General Hospital
Regina, Saskatchewan, Canada, S4P 0W5
Canada
Hopital de Enfant-Jesus
Quebec, Canada, G1J 1Z4
France
CHU de Nantes-Hopital Laennec
Nantes Cedex, France, 44093
United Kingdom
Frenchay Hospital
Bristol, United Kingdom, BS16 1LE
James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3BW
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Richard North, M.D. The Sandra and Malcolm Berman Brain & Spine Institute
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01036529     History of Changes
Other Study ID Numbers: A2005
Study First Received: December 17, 2009
Results First Received: June 4, 2013
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Research Ethics Committee
Canada: Ethics Review Committee

Keywords provided by Boston Scientific Corporation:
Spinal Cord Stimulation
Decompression
Fusion with or without instrumentation
Discectomy
Laminectomy
Laminotomy
Foraminotomy

Additional relevant MeSH terms:
Back Pain
Failed Back Surgery Syndrome
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014