Spinal Cord Stimulation for Predominant Low Back Pain



Status:Active, not recruiting
Conditions:Back Pain, Orthopedic
Therapuetic Areas:Musculoskeletal, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2013

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

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).

The study has a multi-center, prospective, randomized (1:1), open-label, parallel-group
design of two alternative treatments:

- SCS group (SCS+OMM)

- OMM group

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
14
sites
Ogden, Utah 84403
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Albany, NY
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Brussels, 1200
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Brussels,
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Durham, North Carolina 27710
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Durham, NC
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Las Vegas, Nevada 89102
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Las Vegas, NV
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Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Morgantown, WV
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445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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New York, NY
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North Syracuse, New York 13212
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North Syracuse, NY
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Ocean Springs, Mississippi 39564
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Ocean Springs, MS
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Rochester, NY
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Stockbridge, Georgia 30281
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Stockbridge, GA
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Sugar Land, Texas 77478
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Sugar Land, TX
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Washington,
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York, Pennsylvania 17402
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York, PA
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