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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Group Education and Stretching; Procedure: Group Acupuncture

• Study Type: Interventional
• Enrollment (Actual): 431
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Having met American College of Rheumatology (1990) criteria for the diagnosis of fibromyalgia
2. Having a primary Traditional Chinese Medicine (TCM) diagnosis of either Liver Qi Stagnation, Qi and Blood Stagnation, or Qi and Blood Deficiency
3. Female gender
4. Reported average pain of 5 or higher over last week on a scale of 0 to 10 with ten indicating higher pain.
5. Willingness to limit the introduction or change of any medications or treatment modalities for control of fibromyalgia symptoms during the study
6. No TCM in last 3 months (including acupuncture, Chinese herbs or herbal tea pills, tuina (Chinese massage), shiatsu (Japanese massage), qigong and Oriental food therapy)
7. Ability to travel to the intervention and testing sites up to two times weekly
8. Being over 18 and under 75 years of age, and
9. Capability of giving informed consent.

Exclusion Criteria:

1. Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture;
2. Individuals with celiac disease
3. A score greater than 29 on the Beck Depression Inventory
4. Presence of concurrent autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, that causes pain and could potentially confound the analysis;
5. Routine daily use of narcotic analgesics or history of substance abuse;
6. Concurrent participation in other therapeutic trials;
7. Pregnant and nursing mothers (verification of pregnancy status will be determined via a urine test);
8. Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years);
9. Are undergoing disability determination, or are involved in litigation related to fibromyalgia
10. Any impairment, activity or situation that in the judgment of the PI would prevent satisfactory completion of the study protocol
11. Cognitive behavioral therapy in the last 6 months.
12. Non-fluency in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Participation Rate	Rates of treatment attendance in both arms	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drop out rate	Drop out rates in both arms at weeks 10 and 14	10 and 14 weeks
Completion of Evaluation Rates	Completion rates of questionnaires and examinations in both arms	Weeks 0, 5, 10 and 14
Fibromyalgia Impact Questionnaire Revised	Comparing overall score of the Fibromyalgia Impact Questionnaire - Revised between the two arms over time.	Weeks 0, 5, 10, and 14
Nociceptive Reflex Testing	Nociceptive Reflex will be tested at weeks 0, 5, 10 and 14. Changes in nociceptive reflex will be compared within individuals and between arms.	Weeks 0, 5, 10 and 14
Sleep Quality and Daily Activity	Sleep quality and daily activity will be measured using Actiwatch. Changes will be explored within individuals and between groups.	Weeks 0, 5, 10, and 14

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Scott D Mist, PhD, MAcOM, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Estimate): September 24, 2015
• Last Update Submitted That Met QC Criteria: September 22, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Pain; Fatigue; Sleep; Fibromyalgia; Group Acupuncture; Group Education with Stretching; Nociceptive Reflex Testing
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 1K23AT006392 (U.S. NIH Grant/Contract)