Spinal Cord Stimulation for Predominant Low Back Pain

• Status: Completed
• Trial end date: 2017-06-20
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedtronicNeuro

Criteria

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