Complementary and Alternative Medicine (CAM) for Fibromyalgia
This study is an acceptability and feasibility study of two adjunctive interventions: group education with stretching; and group acupuncture. The study population will be women with primary fibromyalgia who have not previously used acupuncture in the last 3 months. Both interventions will be 10 weeks in length and will be conducted at the Oregon Health & Science University. The primary hypothesis is that both arms will be acceptable and feasible in the study population.
Behavioral: Group Education and Stretching
Procedure: Group Acupuncture
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
- Treatment Participation Rate [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]Rates of treatment attendance in both arms
- Drop out rate [ Time Frame: 10 and 14 weeks ] [ Designated as safety issue: No ]Drop out rates in both arms at weeks 10 and 14
- Completion of Evaluation Rates [ Time Frame: Weeks 0, 5, 10 and 14 ] [ Designated as safety issue: No ]Completion rates of questionnaires and examinations in both arms
- Fibromyalgia Impact Questionnaire Revised [ Time Frame: Weeks 0, 5, 10, and 14 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Sleep quality and daily activity will be measured using Actiwatch. Changes will be explored within individuals and between groups.
|Study Start Date:||August 2014|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02053090
|Contact: Deborah Golden-Eppeleinemail@example.com|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Mist 503-494-4326 firstname.lastname@example.org|
|Principal Investigator: Scott D Mist, PhD, MAcOM|
|Principal Investigator:||Scott D Mist, PhD, MAcOM||Oregon Health and Science University|