Analgesic Efficacy of High Frequency Spinal Cord Stimulation
Phase 4
- Conditions
- Lowback and Leg Pain
- Interventions
- Device: High frequency spinal cord stimulation
- Registration Number
- NCT01400282
- Lead Sponsor
- Ensemble Hospitalier de la Côte
- Brief Summary
The aim of the study is to compare the efficacy of high frequency (HF SCS) stimulation and sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation (Conv SCS) on the patient reported global impression of change, pain intensity and health related quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- signed informed consent
- treated with spinal cord stimulation
- stable pain relief achieved
Exclusion Criteria
- failure to give informed consent
- unable to use or understand how to handle the equipment, PGIC,VAS score or EQ-5D questionnaires.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sequence 1 High frequency spinal cord stimulation Conventional stimulation (2 weeks)- High frequeny stimulation (2 weeks)- Conventional stimulation (2 weeks)and sham stimulation (2 weeks) Sequence 2 High frequency spinal cord stimulation Conventional stimulation (2 weeks)- sham stimulation (2weeks) - Conventional stimulation (2 weeks) - high frequeny stimulation (2 weeks)
- Primary Outcome Measures
Name Time Method Patient's Global Impression of Change (PGIC)
- Secondary Outcome Measures
Name Time Method Intensity of Pain Quality of Life (EQ-5D)
Trial Locations
- Locations (2)
Department of anesthesiology and Pain management, Ensemble Hospitalier de la Côte (EHC)
🇨🇭Morges, Switzerland
Department of Anaesthesia, The James Cook University Hospital
🇬🇧Middlesbrough, United Kingdom