Evaluation of HF10 SCS therapy in FBSS patients
- Conditions
- FBSS patients with predominant leg painPatiënten die voornamelijk beenpijn hebben na een gefaalde rugoperatie
- Registration Number
- NL-OMON21128
- Lead Sponsor
- evro Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 55
1.Diagnosed with Failed Back Surgery Syndrome which has been refractory to conservative therapy for a minimum of 3 months and indicated for SCS as per Dutch SCS guidelines and as approved by the Dutch insurance companies
2.Average leg pain intensity of ¡Ý 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
3.Average back pain intensity ¡Ü average leg pain intensity on the Visual Analog Scale (VAS) at enrollment
4.An adult (¡Ý 18 years of age) at time of enrollment
1.A medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints,
2.Evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist
3.A diagnosis of scoliosis that precludes lead placement
4.Radiographic evidence of mechanical spinal instability requiring fusion.
5.Pain that is significantly exacerbated by activity or significantly alleviated by rest
6.Benefitting within 30 days prior to enrollment from an interventional procedure and/or surgery to treat back and/or leg pain
7.Existing drug pump and/or SCS system or another active implantable device such as a pacemaker (switched On or Off)
8.Prior experience with SCS
9.Pregnant
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Responder rate at 12 months
- Secondary Outcome Measures
Name Time Method •Percentage of subjects with a successful trial <br>•Average reduction in leg and back pain, as assessed by VAS, at the different intervals<br>•Percentage change in mean leg and back pain, as assessed by VAS, at the different intervals<br>•Responder rate for leg and back pain, as assessed by VAS, at the different intervals<br>•Change in health status (assessed by SF-36)<br>•Change in disability (assessed by ODI)<br>•Change in emotional mood (assessed by HADS)<br>•Subject's impression of change (assessed by the Patient Global Impression of Change instrument - PGIC)<br>•Investigator¡¯s impression of change (assessed by the Clinician Global Impression of Change instrument - CGIC)<br>•Change in pain experience (MPQ-DLV) <br>•Change in Pain Catastrophizing (PCS) <br>•subject¡¯s satisfaction<br>•Assessment of indirect costs (iPCQ)<br>•Change in pain medication <br>