Fibromyalgia
Conditions
Keywords
Fibromyalgia, Group Acupuncture, Group Education with Stretching, Nociceptive Reflex Testing, Pain, Sleep, Fatigue
Brief summary
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.
Interventions
BEHAVIORALGroup Education and Stretching
PROCEDUREGroup Acupuncture
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Participation Rate | 10 weeks | Rates of treatment attendance in both arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drop out rate | 10 and 14 weeks | Drop out rates in both arms at weeks 10 and 14 |
| Completion of Evaluation Rates | Weeks 0, 5, 10 and 14 | Completion rates of questionnaires and examinations in both arms |
| Fibromyalgia Impact Questionnaire Revised | Weeks 0, 5, 10, and 14 | Comparing overall score of the Fibromyalgia Impact Questionnaire - Revised between the two arms over time. |
| Nociceptive Reflex Testing | 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 | 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. |
Countries
United States
Outcome results
None listed