Effects of Reiki on Painful Neuropathy and Cardiovascular Risk Factors
| Tracking Information | |||||
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| First Received Date ICMJE | February 2, 2001 | ||||
| Last Updated Date | August 17, 2006 | ||||
| Start Date ICMJE | September 1998 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00010751 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 | Effects of Reiki on Painful Neuropathy and Cardiovascular Risk Factors | ||||
| Official Title ICMJE | Chronic Diabetic Painful Neuropathy and Cardiovascular Risk Factors in NIDDM: An Alternative Approach. | ||||
| Brief Summary | The object of this study is to determine if Reiki will improve glycemic control and cardiac autonomic function diabetic patients with painful neuropathy. |
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| Detailed Description | The incidence of coronary heart disease(CHD) in type II diabetes is currently at least 20% in subjects 65 years and older. Numerous data suggest that hyperglycemia may be an independent risk factor for macrovascular complications. Diabetic painful neuropathy (DPN) affects 5-50% of patients with diabetes and is exacerbated by poor glycemic control. DPN is characterized by acute functional abnormalities in nerve fibers followed by chronic nerve fiber loss and blunted nerve fiber regeneration. Symptoms include tingling and burning sensations in the calves, ankles and feet. Pharmacological treatment of diabetic autonomic neuropathy (DAN) and DPN include tricyclic antidepressants, which are cardiotoxic and have a low efficacy rate. The ADA recommends the utilization of diet and exercise as the primary means of glycemic control, and therefore of DPN. Because of the increased levels of extremity pain, patients with DPN are less likely to include exercise as a part of their health regimen. Diabetic autonomic neuropathy (DAN) commonly complicates diabetes and has been invoked as a cause of sudden death in diabetic patients. The excess cardiac mortality in diabetics appears to be augmented by the presence of DAN in patients with advanced deficits in sympathetic cardiovascular enervation which may augment cardiac arrhythmogenesis. An bio-energy modality known as Reiki is an energy manipulation technique similar to Therapeutic Touch, a hands-on modality familiar in nursing for the relief of chronic pain, as well as accelerate healing in full thickness dermal wounds. The study approach is to apply Reiki to patients with DPN +/- DAN in a semi-double blind, randomized, crossover study to ascertain if glycemic control and cardiac autonomic function are improved in these patients. Outcome measures will include HBA1c values, the McGill-Melzack Pain Questionnaire, and a quality of life questionnaire. Participants will also be tested as to their ability to tolerate exercise by a 6 minute walk test. This study will help elucidate whether an bio-energy technique can reduce pain levels, improve glycemic control by increasing exercise tolerance and improve cardiac autonomic function, both major contributors to CHD mortality. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Reiki | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | June 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE |
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| Gender | Both | ||||
| Ages | 20 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00010751 | ||||
| Other Study ID Numbers ICMJE | P50 AT000011-1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | August 2006 | ||||
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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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