Clinical trial NCT02053090: Complementary and Alternative Medicine (CAM) for Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Group Acupuncture
Group Education with Stretching
Nociceptive Reflex Testing
Pain
Sleep
Fatigue
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 431
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment Participation Rate
timeFrame: 10 weeks
Secondary outcomes:
measure: Drop out rate
timeFrame: 10 and 14 weeks
measure: Completion of Evaluation Rates
timeFrame: Weeks 0, 5, 10 and 14
measure: Fibromyalgia Impact Questionnaire Revised
timeFrame: Weeks 0, 5, 10, and 14
measure: Nociceptive Reflex Testing
timeFrame: Weeks 0, 5, 10 and 14
measure: Sleep Quality and Daily Activity
timeFrame: Weeks 0, 5, 10, and 14
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Scott D Mist, PhD, MAcOM
role: PRINCIPAL_INVESTIGATOR
References: