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Integrative Medicine Consultation for Patients With Pain or Fatigue

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01058265
First received: January 27, 2010
Last updated: January 23, 2012
Last verified: January 2012
History of Changes
  Purpose

Patients with a diagnosis of chronic fatigue or pain benefit minimally from a conventional medical evaluation yet consume a large amount of medical resources and time. The question is to see if patients with a diagnosis of chronic pain or fatigue benefit from an Integrative Medicine medical evaluation conducted by physician who has additional training in Integrative Medicine. Patients who call for a general medical examination with a complaint of chronic fatigue or pain will be set up with the integrative medical specialist or standard general medical evaluation.


Condition Intervention
Pain
Fatigue
 Other: Integrative
Other: Standard

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of an Integrative Medicine Consultation on Outcome for Patients With Pain or Fatigue

Resource links provided by NLM:

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Short Form 36 (SF-36) Physical Component Summary (PCS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    It yields an eight-scale profile of scores (physical functioning, social functioning, role-physical, role-emotional, bodily pain, general health, mental health, and vitality) as well as summary physical and mental measures (Ware et al., 1998). The Physical Component Summary ranges from 0 to 100, and higher score indicates better physical condition. It is based on norm-based scoring, which applies a transformation with mean equals to 50 and standard deviation equals to 10, and makes it possible to comparison.

  • Short Form 36 (SF-36) Mental Component Summary (MCS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    It yields an eight-scale profile of scores (physical functioning, social functioning, role-physical, role-emotional, bodily pain, general health, mental health, and vitality) as well as summary physical and mental measures (Ware et al., 1998). The Mental Component Summary ranges from 0 to 100, and higher score indicates better mental health status. It is based on norm-based scoring, which applies a transformation with mean equals to 50 and standard deviation equals to 10, and makes it possible to comparison.


Enrollment: 47
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integrative
Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
 Other: Integrative
Integrative Medicine medical evaluation.
Active Comparator: Standard
Standard general medical evaluation.
 Other: Standard
Standard general medical evaluation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • Patients seeking a medical evaluation for a primary complaint of pain or fatigue.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058265

Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Larry Bergstrom, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Larry Bergstrom, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01058265     History of Changes
Other Study ID Numbers: 08-008497
Study First Received: January 27, 2010
Results First Received: December 15, 2011
Last Updated: January 23, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013