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History of Changes for Study: NCT01036529
Spinal Cord Stimulation With Precision® SCS System Versus Reoperation for Failed Back Surgery Syndrome (Evidence)
Latest version (submitted November 12, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 17, 2009 None (earliest Version on record)
2 January 12, 2010 Study Status and Oversight
3 February 9, 2010 Recruitment Status, Study Status and Contacts/Locations
4 February 12, 2010 Contacts/Locations and Study Status
5 March 26, 2010 Contacts/Locations and Study Status
6 May 4, 2010 Study Status and Contacts/Locations
7 June 25, 2010 Contacts/Locations and Study Status
8 August 16, 2010 Contacts/Locations and Study Status
9 September 28, 2010 Contacts/Locations and Study Status
10 October 5, 2010 Study Status and Contacts/Locations
11 November 3, 2010 Contacts/Locations and Study Status
12 December 15, 2010 Contacts/Locations, Study Status and Sponsor/Collaborators
13 February 22, 2011 Contacts/Locations, Study Status and Eligibility
14 April 25, 2011 Contacts/Locations and Study Status
15 August 3, 2011 Contacts/Locations and Study Status
16 August 30, 2011 Contacts/Locations, Sponsor/Collaborators and Study Status
17 October 4, 2011 Contacts/Locations and Study Status
18 November 17, 2011 Contacts/Locations and Study Status
19 February 13, 2012 Contacts/Locations, Study Status and Eligibility
20 March 5, 2012 Study Status
21 July 9, 2012 Recruitment Status, Contacts/Locations, Study Status, Study Design, Study Description and Conditions
22 May 29, 2013 Study Status
23 May 30, 2013 Study Status
24 September 30, 2013 Arms and Interventions, Study Status, Outcome Measures, Study Identification, Results, Eligibility and Conditions
25 November 12, 2020 Study Status and Baseline Characteristics
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Study NCT01036529
Submitted Date:  February 22, 2011 (v13)

Study Identification
Unique Protocol ID: A2005
Brief Title: Spinal Cord Stimulation With Precision® SCS System Versus Reoperation for Failed Back Surgery Syndrome (Evidence)
Official Title: Spinal Cord Stimulation With Precision® SCS System Versus Reoperation for Failed Back Surgery Syndrome
Secondary IDs:
Study Status
Record Verification: February 2011
Overall Status: Recruiting
Study Start: February 2010
Primary Completion: March 2014 [Anticipated]
Study Completion: May 2017 [Anticipated]
First Submitted: December 17, 2009
First Submitted that
Met QC Criteria:
December 17, 2009
First Posted: December 21, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 22, 2011
Last Update Posted: February 24, 2011 [Estimate]
Sponsor/Collaborators
Sponsor: Boston Scientific Corporation
Responsible Party:
Collaborators:
Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Study Description
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.

The co-primary study endpoints are proportion of subjects with ≥50% leg pain relief without crossover at 6 and at 24 months.

Detailed Description:
Conditions
Conditions: Failed Back Surgery Syndrome
Leg Pain
Back Pain
Spinal Cord Stimulation
Keywords: Spinal Cord Stimulation
Decompression
Fusion with or without instrumentation
Discectomy
Laminectomy
Laminotomy
Foraminotomy
Foraminectomy
Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 132 [Anticipated]
Arms and Interventions
Arms Assigned Interventions
Precision Spinal Cord Stimulator
Spinal Cord Stimulation
Device: Precision Spinal Cord Stimulation
Programming settings will be specific to the individual needs in accordance with the labeling
Other Names:
  • Precision Spinal Cord Stimulator
Reoperation
Discectomy, laminotomy, laminectomy, foraminotomy, foraminectomy, 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
Outcome Measures
Primary Outcome Measures:
1. Proportion of Subjects Showing ≥50% Self-reported Leg Pain Relief From Baseline Without Request for Crossover to the Other Treatment
6- and 24- months post-index procedure
Secondary Outcome Measures:
2. Cost-effectiveness of treatment
6-, 12-, 24-, and 36-months post-index procedure
Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Primary pain type - neuropathic with concordant radicular or neurological findings
  • Chief complaint of radicular leg pain, with or without low back pain after one or more lumbosacral surgical procedures
  • Leg pain intensity of 5 to 10 on standard 0-10 NRS over the past 6 months based on subject recall
  • Leg pain duration of at least 6 months
  • MRI or CT myelogram of the lumbar and thoracic spine rules out a pathology that might compromise SCS electrode placement or pathology in addition to neural compression that might contribute to the subject's pain
  • Study candidates meet the criteria for surgical intervention: pain refractory to conservative care, with concordant neurologic, tension, and/or mechanical signs and imaging findings of surgically remediable neural compression
  • All study candidates must pass study site's routine psychological/psychiatric evaluation for SCS before randomization to SCS or reoperation
  • For all study candidates, a surgeon provides a confirmatory second opinion as to the eligibility for reoperation
  • At least 18 years of age
  • Subject signs informed consent

Exclusion Criteria:

  • Chief complaint of low back pain
  • Pain in a new distribution following the most recent lumbosacral surgical procedure
  • Leg pain intensity of always 10 on a 0-10 NRS over the past 6 months based on subject recall
  • Radiographic evidence of frank instability requiring fusion, calcific arachnoiditis, or severe thoracic stenosis
  • Radiographically demonstrated critical cauda equina compression
  • A disabling or potentially disabling neurologic deficit 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
  • Significant dependency on prescription narcotic analgesics or benzodiazepines
  • Major untreated psychiatric comorbidity
  • Unresolved issues of secondary gain (e.g., litigation)
  • Expected inability to adequately report treatment outcome
  • Expected inability to operate SCS system
  • Pregnancy (actual or planned)
  • Life expectancy less than 3 years due to other serious medical conditions
  • Prior SCS procedure
  • Active local or systemic infection
  • Presence of intrathecal drug pump
  • Participation in another clinical study that will 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/Locations
Central Contact: Natalie Bloom Lyons, MA
Email: Evidence@bsci.com
Locations: United States, California
Scripps Clinic
[Recruiting]
La Jolla, California, United States, 92037
Contact: Gail Moore, RN, BS 858-652-5442 Moore.Gail@scrippshealth.org
University of California San Diego
[Recruiting]
La Jolla, California, United States, 92037
Contact: Michael Beainey 858-657-7039 mbeainy@ucsd.edu
Stanford University
[Not yet recruiting]
Palo Alto, California, United States, 94305
United States, Illinois
Millenium Pain Center
[Recruiting]
Bloomington, Illinois, United States, 61701
Contact: Jessica Short, CRC 309-662-4321 jshort@millenniumpaincenter.com
Northwestern Memorial Hospital
[Recruiting]
Chicago, Illinois, United States, 60611
Contact: Narina Simonian, BS 312-695-1607 nsimonia@nmff.org
The University of Illinois Medical Center
[Recruiting]
Chicago, Illinois, United States, 60612
Contact: Karriem Watson 312-355-0334 kswatson@neur.uic.edu
United States, Maryland
Sinai Hospital of Baltimore
[Recruiting]
Baltimore, Maryland, United States, 21209
Contact: Alan Orpia, BSN 410-601-0960 Aorpia@lifebridgehealth.org
United States, Missouri
St. John's Regional Health Center
[Recruiting]
Springfield, Missouri, United States, 65804
Contact: Linda Thompson, RN 417-820-9538 linda.thompson@mercy.net
United States, New York
New York University Pain Management Center
[Recruiting]
New York, New York, United States, 10016
Contact: Stephanie Ferket 212-263-7935 Stephanie.Ferket@nyumc.org
United States, North Carolina
The Center for Clinical Research, LLC
[Recruiting]
Winston-Salem, North Carolina, United States, 27103
Contact: Sherri Buchanan 336-765-6181 Ext. 195 sbuchanan@ccrpain.com
United States, Pennsylvania
Thomas Jefferson University
[Recruiting]
Philadelphia, Pennsylvania, United States, 19107
Contact: Amanda Salvatore, RN 215-503-5739 amanda.salvatore@jefferson.edu
United States, South Carolina
Medical University of South Carolina
[Recruiting]
Charleston, South Carolina, United States, 29425
Contact: Michele DeCandio, RN, CCRP 843-792-9016 decandio@musc.edu
United States, Texas
Scott and White Hospital
[Recruiting]
Temple, Texas, United States, 76508
Contact: Staci Taggart, RN 254-724-6517 STaggart@swmail.sw.org
United States, Washington
Swedish Medical Center
[Recruiting]
Seattle, Washington, United States, 98104
Contact: Terri Spinelli, CCRC 206-215-3063 Terri.Spinelli@swedish.org
Canada, Saskatchewan
Regina General Hospital
[Recruiting]
Regina, Saskatchewan, Canada, S4P 0W5
Contact: Traci Wiest, RN, BSN 3067663937 traci.wiest@rqhealth.ca
France
CHU de Nantes-Hopital Laennec
[Recruiting]
Nantes Cedex, France, 44093
Contact: Jean-Julien Nizard, MD +33 6 61 84 18 29 julien.nizard@chu-nantes.fr
United Kingdom
Frenchay Hospital
[Recruiting]
Bristol, United Kingdom, BS16 1LE
Contact: Alison Diaper, MBPsS CSci +44 117 3313193 alison.diaper@bristol.ac.uk
IPDSharing
Plan to Share IPD:
References
Citations:
Links:
Available IPD/Information:

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