Analgesic Efficacy of High Frequency Spinal Cord Stimulation

Phase 4

• Conditions: Lowback and Leg Pain

• 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

Study Timeline

• Status Verified: 2011-06
• Study Start: 2011-07
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-21
• Last Update Submitted: 2011-07-21
• Study First Posted: 2011-07-22
• Last Update Posted: 2011-07-22
• Primary Completion: 2012-06
• Study Completion: 2012-09

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

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