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Completed Phase 4 Interventional Results available

Spinal Cord Stimulation for Predominant Low Back Pain

ClinicalTrials.gov ID: NCT01697358

Public ClinicalTrials.gov record NCT01697358. 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, 12:28 AM EDT

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

Official title

Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain

Brief summary

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

The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).

Study identification

NCT ID
NCT01697358
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
MedtronicNeuro
Industry
Enrollment
278 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

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

Study timeline

Start date
Jan 8, 2013 (Actual)
Primary completion
Mar 12, 2016 (Actual)
Completion
Jun 20, 2017 (Actual)
Last update posted
Jul 21, 2017

2013 – 2017

United States locations

U.S. sites
12
U.S. states
9
U.S. cities
12
Facility City State ZIP Site status
Pain Care LLC Stockbridge Georgia 30281 —
The Neuroscience Center Ocean Springs Mississippi 39564 —
Kozmary Center for Pain Management Las Vegas Nevada 89102 —
Albany Medical College Albany New York 12208 —
Weill Medical College of Cornell University New York New York 10021-9800 —
New York Spine and Wellness Center North Syracuse New York 13212 —
University of Rochester Neurosurgery Partners in Pain Management Rochester New York 14618 —
Duke Spine Center Durham North Carolina 27710 —
WellSpan Interventional Pain Center York Pennsylvania 17402 —
Richmond Bone and Joint Clinic Sugar Land Texas 77478 —
Utah Spine Care Ogden Utah 84403 —
West Virginia University Morgantown West Virginia 26506 —

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 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01697358, 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 Jul 21, 2017 · 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 NCT01697358 live on ClinicalTrials.gov.

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