Complementary and Alternative Medicine (CAM) for Fibromyalgia

N/ACompletedNCT02053090

Oregon Health and Science University431 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

431

Conditions

Fibromyalgia

Interventions

Group Education and StretchingBEHAVIORAL

Group AcupuncturePROCEDURE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Treatment Participation Rate

Rates of treatment attendance in both arms

Time frame: 10 weeks

Secondary Outcomes

Drop out rate

Drop out rates in both arms at weeks 10 and 14

Time frame: 10 and 14 weeks

Completion of Evaluation Rates

Completion rates of questionnaires and examinations in both arms

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Weeks 0, 5, 10, and 14

Data from ClinicalTrials.gov

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