Analgesic Efficacy of High Frequency Spinal Cord Stimulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Ensemble Hospitalier de la Côte.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ensemble Hospitalier de la Côte
ClinicalTrials.gov Identifier:
NCT01400282
First received: July 21, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Lowback and Leg Pain
Device: High frequency spinal cord stimulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of High Frequency Spinal Cord Stimulation: a Placebo-controlled Study

Further study details as provided by Ensemble Hospitalier de la Côte:

Primary Outcome Measures:
  • Patient's Global Impression of Change (PGIC)

Secondary Outcome Measures:
  • Intensity of Pain
  • Quality of Life (EQ-5D)

Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Sequence 2
Conventional stimulation (2 weeks)- sham stimulation (2weeks) - Conventional stimulation (2 weeks) - high frequeny stimulation (2 weeks)
Device: High frequency spinal cord stimulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400282

Contacts
Contact: Christophe Perruchoud, MD +41218042868 christophe.perruchoud@chuv.ch

Locations
Switzerland
Department of anesthesiology and Pain management, Ensemble Hospitalier de la Côte (EHC) Recruiting
Morges, Switzerland, 1110
Contact: Christophe Perruchoud, MD    +41218042868    christophe.perruchoud@chuv.ch   
Principal Investigator: Christophe Perruchoud, MD         
Principal Investigator: Eric Buchser, MD         
United Kingdom
Department of Anaesthesia, The James Cook University Hospital Not yet recruiting
Middlesbrough, United Kingdom
Contact: Sam Eldabe, MD    +44 164 228 24 17    Sam.Eldabe@stees.nhs.uk   
Principal Investigator: Sam Eldabe, MD         
Sponsors and Collaborators
Ensemble Hospitalier de la Côte
  More Information

No publications provided

Responsible Party: Perruchoud Christophe, MD, Ensemble Hospitalier de la Côte
ClinicalTrials.gov Identifier: NCT01400282     History of Changes
Other Study ID Numbers: EHC-JCH
Study First Received: July 21, 2011
Last Updated: July 21, 2011
Health Authority: Switzerland: Laws and standards

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014