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Terminated Phase 4 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT01036529

Public ClinicalTrials.gov record NCT01036529. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 2:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01036529
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 4
Lead sponsor
Boston Scientific Corporation
Industry
Enrollment
28 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2010 (Type not available)
Primary completion
May 2013 (Actual)
Completion
May 2013 (Actual)
Last update posted
Nov 16, 2020

2010 – 2013

United States locations

U.S. sites
13
U.S. states
9
U.S. cities
10
Facility City State ZIP Site status
Scripps Clinic La Jolla California 92037 —
University of California San Diego La Jolla California 92037 —
Orthopedic Research Foundation Savannah Georgia 31405 —
Millenium Pain Center Bloomington Illinois 61701 —
Northwestern Memorial Hospital Chicago Illinois 60611 —
The University of Illinois Medical Center Chicago Illinois 60612 —
Sinai Hospital of Baltimore Baltimore Maryland 21209 —
St. Patrick Hospital Missoula Montana 59802 —
The Center for Clinical Research, LLC Winston-Salem North Carolina 27103 —
Geisinger Medical Center Danville Pennsylvania 17822 —
Medical University of South Carolina Charleston South Carolina 29425 —
Swedish Neuroscience Institute Seattle Washington 98122 —
Pacific Medical Center Seattle Washington 98144 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01036529, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 16, 2020 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01036529 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →