Analgesic Efficacy of High Frequency Spinal Cord Stimulation

July 21, 2011 updated by: Ensemble Hospitalier de la Côte

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Morges, Switzerland, 1110
        • Recruiting
        • Department of anesthesiology and Pain management, Ensemble Hospitalier de la Côte (EHC)
        • Contact:
        • Principal Investigator:
          • Christophe Perruchoud, MD
        • Principal Investigator:
          • Eric Buchser, MD
  • United Kingdom
      • Middlesbrough, United Kingdom
        • Not yet recruiting
        • Department of Anaesthesia, The James Cook University Hospital
        • Contact:
        • Principal Investigator:
          • Sam Eldabe, Md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sequence 1
Conventional stimulation (2 weeks)- High frequeny stimulation (2 weeks)- Conventional stimulation (2 weeks)and sham stimulation (2 weeks)
Device: High frequency spinal cord stimulation
Other: Sequence 2
Conventional stimulation (2 weeks)- sham stimulation (2weeks) - Conventional stimulation (2 weeks) - high frequeny stimulation (2 weeks)
Device: High frequency spinal cord stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient's Global Impression of Change (PGIC)

Secondary Outcome Measures

Outcome Measure
Intensity of Pain
Quality of Life (EQ-5D)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ensemble Hospitalier de la Côte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • EHC-JCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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