Complementary and Alternative Medicine (CAM) for Fibromyalgia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Scott Mist, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT02053090
First received: January 30, 2014
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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 tried acupuncture. 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 Intervention
Fibromyalgia
Behavioral: Group Education and Stretching
Procedure: Group Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Treatment Participation Rate [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Rates of treatment attendance in both arms


Secondary Outcome Measures:
  • Drop out rate [ Time Frame: 10 and 14 weeks ] [ Designated as safety issue: No ]
    Drop out rates in both arms at weeks 10 and 14

  • Completion of Evaluation Rates [ Time Frame: Weeks 0, 5, 10 and 14 ] [ Designated as safety issue: No ]
    Completion rates of questionnaires and examinations in both arms

  • Fibromyalgia Impact Questionnaire Revised [ Time Frame: Weeks 0, 5, 10, and 14 ] [ Designated as safety issue: No ]
    Comparing overall score of the Fibromyalgia Impact Questionnaire - Revised between the two arms over time.

  • Nociceptive Reflex Testing [ Time Frame: Weeks 0, 5, 10 and 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weeks 0, 5, 10, and 14 ] [ Designated as safety issue: No ]
    Sleep quality and daily activity will be measured using Actiwatch. Changes will be explored within individuals and between groups.


Estimated Enrollment: 48
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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. TCM naïve (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 65 years of age
  9. Right hand dominance; and
  10. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02053090

Contacts
Contact: Deborah Golden-Eppelein 503-494-4853 goldenep@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Mist    503-494-4326    mists@ohsu.edu   
Principal Investigator: Scott D Mist, PhD, MAcOM         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Scott D Mist, PhD, MAcOM Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Scott Mist, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02053090     History of Changes
Other Study ID Numbers: 1K23AT006392
Study First Received: January 30, 2014
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Fibromyalgia
Group Acupuncture
Group Education with Stretching
Nociceptive Reflex Testing
Pain
Sleep
Fatigue

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 20, 2014