Spinal Cord Stimulation for Predominant Low Back Pain
Condition: Failed Back Surgery Syndrome; Back Pain; Pain in Leg, Unspecified
MeSH terms: Back Pain; Low Back Pain; Failed Back Surgery Syndrome
Intervention: Spinal Cord Stimulation (SCS); Optimal Medical Management (OMM)
Intervention description: Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group.; The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Period I (from randomization to 6 months) is the randomized parallel group comparative phase. Day zero for the study is the point of randomization. The randomization ratio is 1:1 (SCS+OMM to OMM). For the SCS+OMM arm, the screening test and/or implant occurred after randomization. Period II (6 to 24 months) is the long-term observational follow-up phase.
Masking: None (Open Label)
Enrollment: 278.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FBSS; post laminectomy syndrome; SCS; RCT; back pain

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).
    

Eligibility 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