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Complementary and Alternative Medicine (CAM) for Fibromyalgia

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ClinicalTrials.gov Identifier: NCT02053090
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : September 24, 2015
Information provided by (Responsible Party):
Scott Mist, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Group Education and Stretching Procedure: Group Acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 431 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Group Education with Stretching
Group Education with Stretching will receive 10 small group educational classes at the Oregon Health & Science University (OHSU), based on the book "Fibromyalgia (Biographies of Disease)." Each chapter of Fibromyalgia covers different aspects of the disease and its treatment including global, economic, and risk statistics; a timeline of key events in the study of fibromyalgia; common symptoms and diagnostic indicators; natural history of fibromyalgia; pharmacologic and non-pharmacologic treatments; associated disorders and syndromes; and impact of fibromyalgia at home, in the workplace and in society at large. Participants will be informed that they should not start additional treatments until the end of the study and complementary and alternative treatments won't be covered until the last session. Participants will also receive a digital video disk (DVD) covering stretching appropriate for fibromyalgia patients and will be asked to incorporate the DVD over the next 10 weeks.
Behavioral: Group Education and Stretching
Experimental: Group Acupuncture
20 treatments in 10 weeks will include individualized acupuncture in a group setting, dietary and lifestyle recommendations each based on the Traditional Chinese Medicine diagnosis (zhang fu) at the time of the visit.
Procedure: Group Acupuncture

Primary Outcome Measures :
  1. Treatment Participation Rate [ Time Frame: 10 weeks ]
    Rates of treatment attendance in both arms

Secondary Outcome Measures :
  1. Drop out rate [ Time Frame: 10 and 14 weeks ]
    Drop out rates in both arms at weeks 10 and 14

  2. Completion of Evaluation Rates [ Time Frame: Weeks 0, 5, 10 and 14 ]
    Completion rates of questionnaires and examinations in both arms

  3. Fibromyalgia Impact Questionnaire Revised [ Time Frame: Weeks 0, 5, 10, and 14 ]
    Comparing overall score of the Fibromyalgia Impact Questionnaire - Revised between the two arms over time.

  4. Nociceptive Reflex Testing [ Time Frame: 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.

  5. Sleep Quality and Daily Activity [ Time Frame: 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.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02053090

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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
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Principal Investigator: Scott D Mist, PhD, MAcOM Oregon Health and Science University
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Responsible Party: Scott Mist, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02053090    
Other Study ID Numbers: 1K23AT006392 ( U.S. NIH Grant/Contract )
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015
Keywords provided by Scott Mist, Oregon Health and Science University:
Group Acupuncture
Group Education with Stretching
Nociceptive Reflex Testing
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases