Complementary and Alternative Medicine (CAM) for Fibromyalgia

Completed · Not applicable

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT02053090

Run by

Oregon Health and Science University

People needed

431

Starts

2014-08-01

Expected to finish

2015-07-01

Last updated by the study team

2015-09-24

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Having met American College of Rheumatology (1990) criteria for the diagnosis of fibromyalgia
• Having a primary Traditional Chinese Medicine (TCM) diagnosis of either Liver Qi Stagnation, Qi and Blood Stagnation, or Qi and Blood Deficiency
• Female gender
• Reported average pain of 5 or higher over last week on a scale of 0 to 10 with ten indicating higher pain.
• Willingness to limit the introduction or change of any medications or treatment modalities for control of fibromyalgia symptoms during the study
• 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)
• Ability to travel to the intervention and testing sites up to two times weekly
• Being over 18 and under 75 years of age, and
• Capability of giving informed consent.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.