Integrative Medicine Consultation for Patients With Pain or Fatigue

NCT01058265 | Completed Results

• 1 other identifier: 08-008497
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Fatigue

Outcome Measures

Primary Outcomes (2)

• 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.

  3 months

• 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.

  3 months

Study Arms (2)

Integrative

EXPERIMENTAL

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

Standard

ACTIVE COMPARATOR

Standard general medical evaluation.

Other: Standard

Interventions

Integrative OTHER

Integrative Medicine medical evaluation.

Integrative

Standard OTHER

Standard general medical evaluation.

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* Patients seeking a medical evaluation for a primary complaint of pain or fatigue.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Pain; Fatigue

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Larry Bergstrom, MD
• Organization: Mayo Clinic in Arizona

bergstrom.larry@mayo.edu

480-301-7108

Study Officials

• Larry Bergstrom, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 28, 2010
• Study Start: October 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 24, 2012
• Results First Posted: February 24, 2012

Record last verified: 2012-01

Locations

US (1)