Effects of Reiki on Painful Neuropathy and Cardiovascular Risk Factors

August 17, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Martin Stevens, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1998

Study Completion

June 1, 2004

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

February 2, 2001

First Posted (Estimate)

February 5, 2001

Study Record Updates

Last Update Posted (Estimate)

August 18, 2006

Last Update Submitted That Met QC Criteria

August 17, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P50 AT000011-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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