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

NCT01036529 | Terminated Phase 4 Results

• 1 other identifier: A2005
• Study Type: interventional
• Target: 28
• Locations: 4 countries
• Sites: 18

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.

Conditions

Failed Back Surgery Syndrome; Pain; Back Pain

Keywords

Spinal Cord Stimulation; Decompression; Fusion with or without instrumentation; Discectomy; Laminectomy; Laminotomy; Foraminotomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Precision Spinal Cord Stimulator

EXPERIMENTAL

Spinal Cord Stimulation

Device: Precision Spinal Cord Stimulator

Back Surgery

ACTIVE COMPARATOR

Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation

Procedure: Back Surgery

Interventions

Precision Spinal Cord Stimulator DEVICE

Programming settings will be specific to the individual needs in accordance with the labeling

Precision Spinal Cord Stimulator

Back Surgery PROCEDURE

Different types of back surgery may be performed

Also known as: Discectomy, Laminotomy, Laminectomy, Foraminotomy, Foraminectomy, Fusion with or without instrumentation

Back Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (18)

Scripps Clinic

La Jolla, California, 92037, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

Orthopedic Research Foundation

Savannah, Georgia, 31405, United States

Location

Millenium Pain Center

Bloomington, Illinois, 61701, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

The University of Illinois Medical Center

Chicago, Illinois, 60612, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21209, United States

Location

St. Patrick Hospital

Missoula, Montana, 59802, United States

Location

The Center for Clinical Research, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Swedish Neuroscience Institute

Seattle, Washington, 98122, United States

Location

Pacific Medical Center

Seattle, Washington, 98144, United States

Location

Hopital de Enfant-Jesus

Québec, Quebec, G1J 1Z4, Canada

Location

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

Location

CHU de Nantes-Hopital Laennec

Nantes, 44093, France

Location

Frenchay Hospital

Bristol, BS16 1LE, United Kingdom

Location

James Cook University Hospital

Middlesbrough, TS4 3BW, United Kingdom

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Pain; Back Pain

Interventions

Diskectomy; Laminectomy; Foraminotomy; Gene Fusion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Decompression, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures; Recombination, Genetic; Genetic Phenomena

Limitations and Caveats

This study was terminated early due to slow enrollment. Only 28 of the 200 planned subjects were enrolled. Based on the small numbers and early termination, the primary outcome measures were not analyzed.

Results Point of Contact

• Title: Valerie Lucero-Cimmarusti
• Organization: Boston Scientific

Valerie.Lucero-Cimmarusti@bsci.com

661-949-4745

Study Officials

• Richard North, M.D.

  The Sandra and Malcolm Berman Brain & Spine Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: February 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 16, 2020
• Results First Posted: October 28, 2013

Record last verified: 2020-11

Locations

US (13); FR (1); CA (2); GB (2)