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Analgesic Efficacy of High Frequency Spinal Cord Stimulation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Ensemble Hospitalier de la Côte.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01400282
First Posted: July 22, 2011
Last Update Posted: July 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ensemble Hospitalier de la Côte
July 21, 2011
July 22, 2011
July 22, 2011
July 2011
June 2012   (Final data collection date for primary outcome measure)
Patient's Global Impression of Change (PGIC)
Same as current
No Changes Posted
  • Intensity of Pain
  • Quality of Life (EQ-5D)
Same as current
Not Provided
Not Provided
 
Analgesic Efficacy of High Frequency Spinal Cord Stimulation
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Lowback and Leg Pain
Device: High frequency spinal cord stimulation
  • Sequence 1
    Conventional stimulation (2 weeks)- High frequeny stimulation (2 weeks)- Conventional stimulation (2 weeks)and sham stimulation (2 weeks)
    Intervention: Device: High frequency spinal cord stimulation
  • Sequence 2
    Conventional stimulation (2 weeks)- sham stimulation (2weeks) - Conventional stimulation (2 weeks) - high frequeny stimulation (2 weeks)
    Intervention: Device: High frequency spinal cord stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
September 2012
June 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Switzerland,   United Kingdom
 
 
NCT01400282
EHC-JCH
Yes
Not Provided
Not Provided
Perruchoud Christophe, MD, Ensemble Hospitalier de la Côte
Ensemble Hospitalier de la Côte
Not Provided
Not Provided
Ensemble Hospitalier de la Côte
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP