NL-OMON52034
Recruiting
Not Applicable
Multicenter Randomized Clinical Trial to Assess the Effect of Active versus Passive Recharge Burst Spinal Cord Stimulation on Pain Relief in Failed Back Surgery - Active vs. passibe burst in FBSS
Rijnstate Ziekenhuis0 sites94 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronische pijn veroorzaakt door failed back surgery syndrome.
- Sponsor
- Rijnstate Ziekenhuis
- Enrollment
- 94
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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