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Clinical Trials/NCT01400282
NCT01400282
Unknown
Phase 4

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

Ensemble Hospitalier de la Côte2 sites in 2 countries30 target enrollmentJuly 2011
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ConditionsLowback and Leg Pain

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Lowback and Leg Pain
Sponsor
Ensemble Hospitalier de la Côte
Enrollment
30
Locations
2
Primary Endpoint
Patient's Global Impression of Change (PGIC)
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
September 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

Patient's Global Impression of Change (PGIC)

Secondary Outcomes

  • Intensity of Pain
  • Quality of Life (EQ-5D)

Study Sites (2)

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