Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010751
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2001-02-02
Brief Title:
Effects of Reiki on Painful Neuropathy and Cardiovascular Risk Factors
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Chronic Diabetic Painful Neuropathy and Cardiovascular Risk Factors in NIDDM An Alternative Approach
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The incidence of coronary heart diseaseCHD 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None