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Effects of Reiki on Painful Neuropathy and Cardiovascular Risk Factors

Primary Purpose

Coronary Disease, Diabetes Mellitus, Non-Insulin-Dependent

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Reiki
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

NIDDM as defined by the World Health Organization Diagnosed with DPN +/- DAN for a duration of no less than six months Women of childbearing potential must be using an acceptable method of contraception to prevent pregnancy when they are enrolled in the study and must agree to continue to practice an acceptable method of contraception for the duration of their participation Stability of diabetes control by documentation of <1% fluctuation of HbA1c levels over the last twelve months and 3 or less mild hypoglycemic reactions per week. All subjects must be prepared to monitor blood glucose values three to four times daily HbA1c should be <10% Ability to give informed consent and willingness to sign the Institutional Review Board approved consent form Willingness to cooperate with medical therapy and follow up for the 12 months of the study duration Have the ability to understand English

Sites / Locations

  • Taubman Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00010751
Brief Title
Effects of Reiki on Painful Neuropathy and Cardiovascular Risk Factors
Official Title
Chronic Diabetic Painful Neuropathy and Cardiovascular Risk Factors in NIDDM: An Alternative Approach.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Diabetes Mellitus, Non-Insulin-Dependent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Reiki

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
NIDDM as defined by the World Health Organization Diagnosed with DPN +/- DAN for a duration of no less than six months Women of childbearing potential must be using an acceptable method of contraception to prevent pregnancy when they are enrolled in the study and must agree to continue to practice an acceptable method of contraception for the duration of their participation Stability of diabetes control by documentation of <1% fluctuation of HbA1c levels over the last twelve months and 3 or less mild hypoglycemic reactions per week. All subjects must be prepared to monitor blood glucose values three to four times daily HbA1c should be <10% Ability to give informed consent and willingness to sign the Institutional Review Board approved consent form Willingness to cooperate with medical therapy and follow up for the 12 months of the study duration Have the ability to understand English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Stevens, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taubman Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0344
Country
United States

12. IPD Sharing Statement

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Effects of Reiki on Painful Neuropathy and Cardiovascular Risk Factors

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