Loading clinical trials...

Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome | Clinical Trials | Clareo Health

TERMINATEDPHASE4

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

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

NCT01036529•Boston Scientific Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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)
+10 more criteria

Locations (18)

Scripps Clinic

La Jolla, California, United States

University of California San Diego

La Jolla, California, United States

Orthopedic Research Foundation

Savannah, Georgia, United States

Millenium Pain Center

Bloomington, Illinois, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

The University of Illinois Medical Center

Chicago, Illinois, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

St. Patrick Hospital

Missoula, Montana, United States

The Center for Clinical Research, LLC

Winston-Salem, North Carolina, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Key Dates

Start Date

February 1, 2010

Primary Completion Date

May 1, 2013

Completion Date

May 1, 2013

Last Updated

November 16, 2020

Enrollment

ACTUAL participants

Conditions

Failed Back Surgery SyndromePainBack Pain

Interventions

Precision Spinal Cord Stimulator

DEVICE

Back Surgery

PROCEDURE

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

NCT06346132

Virtual RealityMedical Device+2 more

View study

RECRUITINGPHASE1

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

NCT07351968

Moderate Pain in Knee OsteoarthritisSevere Pain in Knee Osteoarthritis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 16, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

Comparison Between Tranversus Abdominis Plane (TAP) Block With Only Bupivacaine and TAP Block With Bupivacaine Plus Ketamine in Reducing Postoperative Pain After Total Abdominal Hystrectomy

Intertransverse Process Block to Improve Quality of Recovery and Pain Management in Adult Cardiac Surgical Patients

Evaluating Postoperative Pain and Antibacterial Effect of Ultrasonic and 980 nm Diode Laser Combination

Effects of Erector Spinae Plane Block on Postoperative Pain Following Lumbar Fusion Surgery