Multicenter Randomized Clinical Trial to Assess the Effect of Active versus Passive Recharge Burst Spinal Cord Stimulation on Pain Relief in Failed Back Surgery

Recruiting

Conditions: Chronische pijn veroorzaakt door failed back surgery syndrome.
chronic low back pain
Failed back surgery syndrome

Registration Number: NL-OMON52034

Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 94

Inclusion Criteria

• 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

Exclusion Criteria

• 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
<p>The primary endpoint is pain catastrophizing at 6 months after treatment<br /><br>started as measured with the pain catastrophizing scale (PCS).</p><br>

Secondary Outcome Measures