Analgesic Efficacy of High Frequency Spinal Cord Stimulation

Lowback and Leg Pain Clinical Trial

Official title:

Analgesic Efficacy of High Frequency Spinal Cord Stimulation: a Placebo-controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01400282
• Other study ID #: EHC-JCH
• Status: Recruiting
• Phase: Phase 4
• First received: July 21, 2011
• Last updated: July 21, 2011
• Start date: July 2011
• Est. completion date: September 2012

Study information

• Verified date: June 2011
• Source: Ensemble Hospitalier de la Côte
• Contact: Christophe Perruchoud, MD
• Phone: +41218042868
• Email: christophe.perruchoud[@]chuv.ch
• Is FDA regulated: No
• Health authority: Switzerland: Laws and standards
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2012
• Est. primary completion date: June 2012
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lowback and Leg Pain

Intervention

Device:
• High frequency spinal cord stimulation

Locations

Country	Name	City	State
Switzerland	Department of anesthesiology and Pain management, Ensemble Hospitalier de la Côte (EHC)	Morges
United Kingdom	Department of Anaesthesia, The James Cook University Hospital	Middlesbrough

Sponsors (1)

Lead Sponsor	Collaborator
Ensemble Hospitalier de la Côte

Countries where clinical trial is conducted

Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's Global Impression of Change (PGIC)
Secondary	Intensity of Pain
Secondary	Quality of Life (EQ-5D)