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Integrative Medicine Consultation for Patients With Pain or Fatigue

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01058265
First Posted: January 28, 2010
Last Update Posted: February 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mayo Clinic
  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: None (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:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Short Form 36 (SF-36) Physical Component Summary (PCS) [ Time Frame: 3 months ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Patients seeking a medical evaluation for a primary complaint of pain or fatigue.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Larry Bergstrom, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01058265     History of Changes
Other Study ID Numbers: 08-008497
First Submitted: January 27, 2010
First Posted: January 28, 2010
Results First Submitted: December 15, 2011
Results First Posted: February 24, 2012
Last Update Posted: February 24, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms