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Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue

This study has been terminated.
(IRB ended and NIH study ended)
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00983502
First received: September 22, 2009
Last updated: December 13, 2011
Last verified: December 2011
  Purpose
The investigators' long-term goal is to identify, and then provide general practitioners with evidence-based recommendations for therapeutic interventions for unexplained chronic fatigue (UCF). The investigators' central hypothesis guiding this application is that some complimentary and alternative medicine (CAM) practitioners have developed management approaches that are more helpful to patients with UCF than usual care.

Condition
Idiopathic Chronic Fatigue
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Differences among four groups of clinicians with respect to patient treatment outcome [ Time Frame: Six months ]

Enrollment: 154
Study Start Date: August 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Integrative Medicine
Patients of MD practitioners trained in Complementary and Alternative Medicine
Naturopath Doctors
Patients of practitioners who are not MD's and are trained in Naturopathic Medicine
Chronic Fatigue Specialists
Patients of MD's who specialize in treating Chronic Fatigue and related conditions
Control Group
Patients treated by primary care MDs in practice-based research networks

Detailed Description:
An objective is to identify certain types of clinicians (or individual physicians) who appear to have identified effective treatments for patients with UCF, or to find that clinicians who report themselves to be effective are not. Study subjects will be UCF patients new to the practice of one of four groups of participating clinicians: 1) a control group of MDs in practice-based research networks, 2) MDs trained in CAM, 3) naturopathic doctors (non MDs trained in special naturopathic schools), and 4) MDs who specialize in chronic fatigue. Our rationale for this comparison is that its successful completion will potentially guide future searches for effective medical strategies for the treatment of UCF that may have been developed outside the mainstream medical community. It may also provide necessary information for follow-up studies that will help to identify specific effective treatments. This information includes which clinicians provide the best treatments (as evidenced by having patients with the best results), what are the characteristics of patients who respond to a particular treatment, how the data collection procedures might need to be refined and what sample sizes are necessary.
  Eligibility

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The primary analyses will compare outcomes for 240 patients in four main groups (60 in each group) defined by the background of the treating clinicians. Study subjects will be UCF patients new to the practice of one of four groups of participating clinicians.
Criteria

Inclusion Criteria:

  1. Age 21 through 65.
  2. Has severe debilitating fatigue that substantially reduces the quality of life.
  3. Does not have any organic, psychological, or lifestyle problems that are the primary disorder and are likely to be the cause of this fatigue (see exclusionary criteria)
  4. The severe, unexplained fatigue has persisted for at least six months.
  5. Has not been previously treated by current physician for chronic fatigue.
  6. Can speak and read English.
  7. Is not pregnant or planning to become pregnant within six months.
  8. Has a telephone.

Exclusion Criteria:

No known history of:

  1. Bipolar disorder
  2. Psychosis
  3. Major Depressive Disorder
  4. Sleep disorder
  5. Anemia
  6. Thyroid disease
  7. Rheumatoid Arthritis
  8. Systemic Lupus
  9. Cancer
  10. Heart disease
  11. Liver disease
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983502

Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Arthur J Hartz, MD, PhD Huntsman Cancer Institute/ University of Utah
  More Information

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00983502     History of Changes
Other Study ID Numbers: 25988
R21AT004537-02 ( US NIH Grant/Contract Award Number )
Study First Received: September 22, 2009
Last Updated: December 13, 2011

Keywords provided by University of Utah:
Idiopathic Chronic Fatigue
Chronic Fatigue Syndrome
Myalgic encephalomyelitis

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Myalgia
Encephalomyelitis
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Central Nervous System Infections

ClinicalTrials.gov processed this record on May 24, 2017