Spinal Cord Stimulation for Predominant Low Back Pain

Completed · Phase 4

Conditions studied: Failed Back Surgery Syndrome, Back Pain, Pain in Leg, Unspecified

In brief

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).

Key facts

Study ID

NCT01697358

Run by

MedtronicNeuro

People needed

278

Starts

2013-01-08

Expected to finish

2017-06-20

Last updated by the study team

2017-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• SCS candidate with the Specify 5-6-5 surgical lead
• Has FBSS and does not require further surgery (defined as persistent or recurrent low back and leg pain of at least 6 months duration following at least one decompression and/or fusion procedure)
• Average low back pain is ≥ 5 as assessed by the baseline NPRS
• Average low back pain is greater than leg pain
• Subject has persistent moderate to severe low back and leg pain despite other treatments

You may not qualify if…

• Treated with SCS, subcutaneous or peripheral nerve stimulation, an intrathecal drug delivery system, requires back surgery at the location related to his/her original back pain complaint or experimental therapies
• Most recent back surgery < 6 months ago
• Low back pain only (no leg pain)
• Investigator suspects substance abuse that might confound the study results
• Radiographic evidence of instability requiring fusion
• Pain relieved completely by lying down
• Life expectancy of < 24 months
• Subject is pregnant or planning to become pregnant during the course of the study
• Subject is unable to undergo study assessments or complete questionnaires independently

Where it is running

• Pain Care LLC — Stockbridge, Georgia, United States
• The Neuroscience Center — Ocean Springs, Mississippi, United States
• Kozmary Center for Pain Management — Las Vegas, Nevada, United States
• Albany Medical College — Albany, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States
• New York Spine and Wellness Center — North Syracuse, New York, United States
• University of Rochester Neurosurgery Partners in Pain Management — Rochester, New York, United States
• Duke Spine Center — Durham, North Carolina, United States
• WellSpan Interventional Pain Center — York, Pennsylvania, United States
• Richmond Bone and Joint Clinic — Sugar Land, Texas, United States
• Utah Spine Care — Ogden, Utah, United States
• West Virginia University — Morgantown, West Virginia, United States
• UCL St. Luc — Brussels, Belgium
• AZ St. Maarten — Duffel, Belgium
• CHR Citadelle — Liège, Belgium
• Heilig Hart Ziekenhuis — Roeselare, Belgium
• Department of Neurosurgery: St. Augustinus Ziekenhuizen — Wilrijk, Belgium
• Regina General Hospital — Regina, Canada
• Clínica Las Américas — Medellín, Antioquia, Colombia
• Hospital Pablo Tobón Uribe — Medellín, Antioquia, Colombia
• San Vicente Fundación — Rionegro, Antioquia, Colombia
• Centre Hospitalier Universitaire de Poitiers — Poitiers, France
• Städtisches Klinikum Görlitz gGmbH — Görlitz, Germany
• St. Elisabeth Ziekenhuis Tilburg — Tilburg, Netherlands
• Hospital Clinico Universitario de Valencia — Valencia, Spain

Full record on ClinicalTrials.gov

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