Multicenter Randomized Clinical Trial to Assess the Effect of Active versus Passive recharge Burst Spinal Cord Stimulation on Pain Relief in Failed Back Surgery Syndrome
- Conditions
- Failed back surgery syndrome, chronic low back pain
- Registration Number
- NL-OMON27344
- Lead Sponsor
- Abbott Laboratories
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 96
Subject of either gender between 18 and 65 years of age
• Al least moderate level of catastrophizing as measured with the Pain catastrophizing score (PCS) of at least 20.[23]
• History consistent with FBSS of at least 6 months
• Neurologic exam without marked motor deficit.
• Low Back Pain or leg pain intensity should be 5 or higher measured with the 11-box NRS 0-10
• Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center. PM: depression is not an exclusion criteria
• Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation
• Subject is able and willing to comply with the follow-up schedule and protocol
• Subject is able to provide written informed consent
Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
• Escalating or changing pain condition within the past month as evidenced by investigator examination
• BMI =35
• Subject has had injection therapy or radiofrequency treatment for their low back pain within the past 3 months
• Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
• Subject is unable to operate the device
• Severe disc degeneration at the affected level as evidenced by >50% disc height loss on plain anteroposterior and lateral lumbar radiographs or CT/MRI.
• Moderate to severe spinal stenosis due to osteophyte and/or ligamentous overgrowth as evidenced by MRI or CT in the previous 6 months
• Moderate to severe endplate degenerative changes at the affected levels
• Grade 1-2 spondylolisthesis
• Previous Neurostimulation therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is pain catastrophizing at 6 months after treatment started as measured with the pain catastrophizing scale
- Secondary Outcome Measures
Name Time Method