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van CCT (UK)

van CCT (UK)

Evaluation of HF10 SCS therapy in FBSS patients

- candidate number21144
- NTR NumberNTR4965
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-dec-2014
- Secondary IDsCA2014NL FBSS Sponsor
- Public TitleEvaluation of HF10 SCS therapy in FBSS patients
- Scientific TitleA Clinical Study to Evaluate the Clinical Performance of HF10™ SCS Therapy in Failed Back Surgery Syndrome Patients in the Dutch Healthcare System
- hypothesis
- Healt Condition(s) or Problem(s) studiedLeg pain, Backsurgery
- Inclusion criteria1. 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 °› 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment 3. Average back pain intensity °‹ average leg pain intensity on the Visual Analog Scale (VAS) at enrollment 4. An adult (°› 18 years of age) at time of enrollment
- Exclusion criteria1. 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
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-mrt-2015
- planned closingdate31-dec-2016
- Target number of participants55
- InterventionsAll subjects will have a Trial Phase with a Senza® external trial stimulator of min 7 days and max 21 days to determine if they respond to HF10™ SCS therapy. Following the Trial Phase, subjects will be assessed for their pain, and those who have a successful trial (defined as a 50% or greater leg pain reduction from Baseline) will proceed to permanent implantation of the SCS system. In case the trial was unsuccessful, the study ends for the subject . Subjects with a successful trial will be implanted with the permanent HF10 system. Subjects will be followed for a period of 12 months post-implant, At specific intervals (1, 3, 6 and 12 months) the required information will be collected for comparison with the baseline data.
- Primary outcomeResponder rate at 12 months
- Secondary outcome• Percentage of subjects with a successful trial • Average reduction in leg and back pain, as assessed by VAS, at the different intervals • Percentage change in mean leg and back pain, as assessed by VAS, at the different intervals • Responder rate for leg and back pain, as assessed by VAS, at the different intervals • Change in health status (assessed by SF-36) • Change in disability (assessed by ODI) • Change in emotional mood (assessed by HADS) • Subject's impression of change (assessed by the Patient Global Impression of Change instrument - PGIC) • Investigator°Įs impression of change (assessed by the Clinician Global Impression of Change instrument - CGIC) • Change in pain experience (MPQ-DLV) • Change in Pain Catastrophizing (PCS) • subject°Įs satisfaction • Assessment of indirect costs (iPCQ) • Change in pain medication
- TimepointsPrimary outcome - Timepoint 12 months Secondary Pain outcomes - Timepoint: 1, 3, 6 and 12 Mo SF=36, ODI, HADS, PGIC, CGIC, MPQ-DLV, PCS - Timepoint:1, 6 and 12 Mo Subject Satisfaction and indirect cost- Timepoint: 12 Mo
- Trial web site
- statusplanned
- Sponsor/Initiator Nevro Corp.
- Funding
(Source(s) of Monetary or Material Support)
Nevro Corp.
- Publications
- Brief summaryStudy will be performed in the Netherlands.
- Main changes (audit trail)
- RECORD11-dec-2014 - 25-mrt-2015

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