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Completed

NCT Number: NCT02053090

Complementary and Alternative Medicine (CAM) for Fibromyalgia

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having met American College of Rheumatology (1990) criteria for the diagnosis of fibromyalgia
  • Having a primary Traditional Chinese Medicine (TCM) diagnosis of either Liver Qi Stagnation, Qi and Blood Stagnation, or Qi and Blood Deficiency
  • Female gender
  • Reported average pain of 5 or higher over last week on a scale of 0 to 10 with ten indicating higher pain.
  • Willingness to limit the introduction or change of any medications or treatment modalities for control of fibromyalgia symptoms during the study
  • 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)
  • Ability to travel to the intervention and testing sites up to two times weekly
  • Being over 18 and under 75 years of age, and
  • Capability of giving informed consent.

Exclusion criteria

  • Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture;
  • Individuals with celiac disease
  • A score greater than 29 on the Beck Depression Inventory
  • Presence of concurrent autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, that causes pain and could potentially confound the analysis;
  • Routine daily use of narcotic analgesics or history of substance abuse;
  • Concurrent participation in other therapeutic trials;
  • Pregnant and nursing mothers (verification of pregnancy status will be determined via a urine test);
  • Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years);
  • Are undergoing disability determination, or are involved in litigation related to fibromyalgia
  • Any impairment, activity or situation that in the judgment of the PI would prevent satisfactory completion of the study protocol
  • Cognitive behavioral therapy in the last 6 months.
  • Non-fluency in English

Treatment and study plan

Group Education and Stretching

Behavioral

Group Acupuncture

Procedure

Primary outcomes

  1. Treatment Participation Rate

    Time frame: 10 weeks

    Rates of treatment attendance in both arms

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 3, 2014
Registry last updated
Sep 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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