Back to resultsIntegrative Medicine Consultation for Patients With Pain or Fatigue
Primary Purpose
Pain, Fatigue
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrative
Standard
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
- Patients seeking a medical evaluation for a primary complaint of pain or fatigue.
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Integrative
Standard
Arm Description
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.
Standard general medical evaluation.
Outcomes
Primary Outcome Measures
Short Form 36 (SF-36) Physical Component Summary (PCS)
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)
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01058265
Brief Title
Integrative Medicine Consultation for Patients With Pain or Fatigue
Official Title
Effect of an Integrative Medicine Consultation on Outcome for Patients With Pain or Fatigue
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Integrative
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Standard general medical evaluation.
Intervention Type
Other
Intervention Name(s)
Integrative
Intervention Description
Integrative Medicine medical evaluation.
Intervention Type
Other
Intervention Name(s)
Standard
Intervention Description
Standard general medical evaluation.
Primary Outcome Measure Information:
Title
Short Form 36 (SF-36) Physical Component Summary (PCS)
Description
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.
Time Frame
3 months
Title
Short Form 36 (SF-36) Mental Component Summary (MCS)
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients seeking a medical evaluation for a primary complaint of pain or fatigue.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Bergstrom, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Integrative Medicine Consultation for Patients With Pain or Fatigue
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