Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT)
| Tracking Information | |||||
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| First Received Date ICMJE | February 12, 2007 | ||||
| Last Updated Date | January 8, 2008 | ||||
| Start Date ICMJE | February 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Measuring using questionnaires and therapy measurements. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00435318 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT) | ||||
| Official Title ICMJE | Lateral Epicondylitis Iontophoresis Randomized Control Trial (LERCT) | ||||
| Brief Summary | The intent of this double-blinded study is to investigate the short (2 months) and long-term (over 2 months) therapeutic capabilities of Iontophoresis. |
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| Detailed Description | The intent of this double-blinded study is to investigate the short (2 months) and long-term (over 2 months) therapeutic capabilities of Iontophoresis. We anticipate that patients treated with Iontophoresis will have improved scores on the VAS and DASH assessments, and will recover more quickly than those patients receiving the Sham treatment. A Sham treatment is a method used in medical trials to help researchers determine the effectiveness of a drug/treatment which in this case will be Iontophoretic Administration using Dexamethasone. Placebos are inactive substances (Saline) used in this study to compare results with an active substance (Dexamethasone). Furthermore, it is the hope of this research team that through careful analysis and comparison of these two treatment arms a clear conclusion is met regarding the efficacy of Iontophoresis as a powerful treatment paradigm for patients suffering from this disorder. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE | Lateral Epicondylitis | ||||
| Intervention ICMJE | Procedure: Iontophoresis | ||||
| Study Arm (s) | Not Provided | ||||
| 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 | Withdrawn | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | January 2009 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Patient selection factors include:
Exclusion Criteria
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00435318 | ||||
| Other Study ID Numbers ICMJE | 060984 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Vanderbilt University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt University | ||||
| Verification Date | January 2008 | ||||
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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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