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
Recruitment status was Recruiting
Sponsor:
Ensemble Hospitalier de la Côte
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
| Tracking Information | |||||
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| First Received Date ICMJE | July 21, 2011 | ||||
| Last Updated Date | July 21, 2011 | ||||
| Start Date ICMJE | July 2011 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Patient's Global Impression of Change (PGIC) | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Analgesic Efficacy of High Frequency Spinal Cord Stimulation | ||||
| Official Title ICMJE | Analgesic Efficacy of High Frequency Spinal Cord Stimulation: a Placebo-controlled Study | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Lowback and Leg Pain | ||||
| Intervention ICMJE | Device: High frequency spinal cord stimulation | ||||
| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | September 2012 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland, United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01400282 | ||||
| Other Study ID Numbers ICMJE | EHC-JCH | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Perruchoud Christophe, MD, Ensemble Hospitalier de la Côte | ||||
| Study Sponsor ICMJE | Ensemble Hospitalier de la Côte | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Ensemble Hospitalier de la Côte | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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