Complementary and Alternative Medicine (CAM) for Fibromyalgia
|ClinicalTrials.gov Identifier: NCT02053090|
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : September 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Behavioral: Group Education and Stretching Procedure: Group Acupuncture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||431 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Active Comparator: Group Education with Stretching
Group Education with Stretching will receive 10 small group educational classes at the Oregon Health & Science University (OHSU), based on the book "Fibromyalgia (Biographies of Disease)." Each chapter of Fibromyalgia covers different aspects of the disease and its treatment including global, economic, and risk statistics; a timeline of key events in the study of fibromyalgia; common symptoms and diagnostic indicators; natural history of fibromyalgia; pharmacologic and non-pharmacologic treatments; associated disorders and syndromes; and impact of fibromyalgia at home, in the workplace and in society at large. Participants will be informed that they should not start additional treatments until the end of the study and complementary and alternative treatments won't be covered until the last session. Participants will also receive a digital video disk (DVD) covering stretching appropriate for fibromyalgia patients and will be asked to incorporate the DVD over the next 10 weeks.
Behavioral: Group Education and Stretching
Experimental: Group Acupuncture
20 treatments in 10 weeks will include individualized acupuncture in a group setting, dietary and lifestyle recommendations each based on the Traditional Chinese Medicine diagnosis (zhang fu) at the time of the visit.
Procedure: Group Acupuncture
- Treatment Participation Rate [ Time Frame: 10 weeks ]Rates of treatment attendance in both arms
- Drop out rate [ Time Frame: 10 and 14 weeks ]Drop out rates in both arms at weeks 10 and 14
- Completion of Evaluation Rates [ Time Frame: Weeks 0, 5, 10 and 14 ]Completion rates of questionnaires and examinations in both arms
- Fibromyalgia Impact Questionnaire Revised [ Time Frame: Weeks 0, 5, 10, and 14 ]Comparing overall score of the Fibromyalgia Impact Questionnaire - Revised between the two arms over time.
- Nociceptive Reflex Testing [ Time Frame: Weeks 0, 5, 10 and 14 ]Nociceptive Reflex will be tested at weeks 0, 5, 10 and 14. Changes in nociceptive reflex will be compared within individuals and between arms.
- Sleep Quality and Daily Activity [ Time Frame: Weeks 0, 5, 10, and 14 ]Sleep quality and daily activity will be measured using Actiwatch. Changes will be explored within individuals and between groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053090
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Scott D Mist, PhD, MAcOM||Oregon Health and Science University|