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Effects of Reiki on Painful Neuropathy and Cardiovascular Risk Factors - Article


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Clinical Trial: Effects of Reiki on Painful Neuropathy and Cardiovascular Risk Factors

This study is no longer recruiting patients.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

The object of this study is to determine if Reiki will improve glycemic control and cardiac autonomic function diabetic patients with painful neuropathy.

Condition Treatment or Intervention Phase
Coronary Disease
Diabetes Mellitus, Non-Insulin-Dependent
 Procedure: Reiki
Phase II

MedlinePlus related topics:  Coronary Disease;   Diabetes

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind

Official Title: Chronic Diabetic Painful Neuropathy and Cardiovascular Risk Factors in NIDDM: An Alternative Approach.

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  20 Years   -   80 Years,  Genders Eligible for Study:  Both

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

Location Information


Michigan
      Taubman Center, Ann Arbor,  Michigan,  48109-0344,  United States

Study chairs or principal investigators

Martin Stevens, MD,  Principal Investigator,  University of Michigan   

More Information

Study ID Numbers:  8 P50 AT00011-02P1
Record last reviewed:  October 2004
Last Updated:  October 16, 2004
Record first received:  February 2, 2001
ClinicalTrials.gov Identifier:  NCT00010751
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: September 6, 2005
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