Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome
Condition: Failed Back Surgery Syndrome; Pain; Back Pain
MeSH terms: Syndrome; Failed Back Surgery Syndrome
Intervention: Precision Spinal Cord Stimulator; Back Surgery
Intervention description: Programming settings will be specific to the individual needs in accordance with the labeling; Different types of back surgery may be performed
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Spinal Cord Stimulation; Decompression; Fusion with or without instrumentation; Discectomy; Laminectomy; Laminotomy; Foraminotomy

Summary:

      The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness
      and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as
      a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). FBSS is defined as
      persistent or recurrent pain following one or more lumbosacral spine surgical procedures.
      Surgical procedures that can result in FBSS can be categorized as either decompression or
      decompression followed by fusion with or without instrumentation. The pain of FBSS is
      categorized as neuropathic, which involves pathological nerve activity and is commonly
      characterized by patients as shooting or burning and/or nociceptive, which signals actual or
      impending tissue damage or inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary pain type - neuropathic with concordant radicular or neurological findings

          -  Significant complaint of persistent or recurrent radicular leg pain, with or without
             low back pain

          -  One or more prior lumbosacral surgical procedures (no upper limit)

          -  At least 6 months duration of persistent or recurrent radicular leg pain, with or
             without low back pain

          -  Study candidates meet the criteria for a specific surgical intervention as recorded by
             a surgeon: pain refractory to conservative care, with concordant neurologic, tension,
             and/or mechanical signs and imaging findings of surgically remediable neural
             compression

          -  MRI or CT myelogram of the lumbar and thoracic spine (within 12 months prior to
             screening) that rules out pathology that might compromise SCS electrode placement or
             pathology, in addition to neural compression, that might contribute to the subject's
             pain

          -  All study candidates must pass study site's routine psychological/psychiatric
             evaluation for SCS before randomization to SCS or reoperation

          -  At least 18 years of age

          -  Subject signs informed consent

        Exclusion Criteria:

          -  Chief complaint of mechanical low back pain (e.g. pain that a recumbent position
             relieves completely)

          -  Pain intensity of always 10 on a 0-10 Numerical Rating Scale over the past 6 months
             based on subject recall

          -  Radiographic evidence of frank instability (grossly mobile spondylolisthesis or
             abnormal subluxation) requiring fusion, calcific arachnoiditis, or severe thoracic
             stenosis

          -  Radiographically demonstrated (by myelographic block or its MRI equivalent) critical
             cauda equinal compression

          -  A disabling or potentially disabling neurologic deficit (e.g., foot drop, neurogenic
             bladder) in the distribution of a nerve root or roots caused by surgically remediable
             compression

          -  A predominance of non-organic signs on physical exam

          -  A concurrent clinically significant or disabling chronic pain problem or condition
             that is likely to confound evaluation of study endpoints (e.g., chronic migraine,
             significant arthrosis of the hip associated with groin pain as primary complaint)

          -  Significant substance abuse issues

          -  Major untreated psychiatric comorbidity

          -  Unresolved issues of secondary gain (e.g., litigation)

          -  Expected inability to report treatment outcome adequately

          -  Expected inability to operate SCS system

          -  Pregnancy (actual or planned)

          -  Life expectancy less than 3 years due to other serious medical condition(s)

          -  Active local or systemic infection

          -  Prior SCS procedure

          -  Presence of intrathecal drug pump

          -  Participation in another clinical study that would confound data of this study

          -  Occupational risk that would rule out SCS

          -  Medical or cardiac condition(s) or therapies, or foreseeable need for therapies or
             diagnostic tests (e.g., MRI), that preclude SCS and/or reoperation