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

Pain Clinical Trial

— Evidence  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01036529
• Other study ID #: A2005
• Status: Terminated
• Phase: Phase 4
• Start date: February 2010
• Est. completion date: May 2013

Study information

• Verified date: November 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Failed Back Surgery Syndrome
• Pain
• Syndrome

Intervention

Device:
• Precision Spinal Cord Stimulator
Programming settings will be specific to the individual needs in accordance with the labeling

Procedure:
• Back Surgery
Different types of back surgery may be performed

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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