Complementary and Alternative Medicine (CAM) for Fibromyalgia

Fibromyalgia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053090
• Other study ID #: 1K23AT006392
• Status: Completed
• Phase: N/A
• First received: January 30, 2014
• Last updated: September 22, 2015
• Start date: August 2014
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Group Education and Stretching

Procedure:
• Group Acupuncture

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Participation Rate	Rates of treatment attendance in both arms	10 weeks	No
Secondary	Drop out rate	Drop out rates in both arms at weeks 10 and 14	10 and 14 weeks	No
Secondary	Completion of Evaluation Rates	Completion rates of questionnaires and examinations in both arms	Weeks 0, 5, 10 and 14	No
Secondary	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	No
Secondary	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	No
Secondary	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	No