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Complementary and Alternative Medicine (CAM) for Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Education and Stretching
Group Acupuncture
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Group Acupuncture, Group Education with Stretching, Nociceptive Reflex Testing, Pain, Sleep, Fatigue

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group Education with Stretching

Group Acupuncture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Treatment Participation Rate
Rates of treatment attendance in both arms

Secondary Outcome Measures

Drop out rate
Drop out rates in both arms at weeks 10 and 14
Completion of Evaluation Rates
Completion rates of questionnaires and examinations in both arms
Fibromyalgia Impact Questionnaire Revised
Comparing overall score of the Fibromyalgia Impact Questionnaire - Revised between the two arms over time.
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.
Sleep Quality and Daily Activity
Sleep quality and daily activity will be measured using Actiwatch. Changes will be explored within individuals and between groups.

Full Information

First Posted
January 30, 2014
Last Updated
September 22, 2015
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT02053090
Brief Title
Complementary and Alternative Medicine (CAM) for Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Group Acupuncture, Group Education with Stretching, Nociceptive Reflex Testing, Pain, Sleep, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
431 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Education with Stretching
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group Acupuncture
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Education and Stretching
Intervention Type
Procedure
Intervention Name(s)
Group Acupuncture
Primary Outcome Measure Information:
Title
Treatment Participation Rate
Description
Rates of treatment attendance in both arms
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Drop out rate
Description
Drop out rates in both arms at weeks 10 and 14
Time Frame
10 and 14 weeks
Title
Completion of Evaluation Rates
Description
Completion rates of questionnaires and examinations in both arms
Time Frame
Weeks 0, 5, 10 and 14
Title
Fibromyalgia Impact Questionnaire Revised
Description
Comparing overall score of the Fibromyalgia Impact Questionnaire - Revised between the two arms over time.
Time Frame
Weeks 0, 5, 10, and 14
Title
Nociceptive Reflex Testing
Description
Nociceptive Reflex will be tested at weeks 0, 5, 10 and 14. Changes in nociceptive reflex will be compared within individuals and between arms.
Time Frame
Weeks 0, 5, 10 and 14
Title
Sleep Quality and Daily Activity
Description
Sleep quality and daily activity will be measured using Actiwatch. Changes will be explored within individuals and between groups.
Time Frame
Weeks 0, 5, 10, and 14

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott D Mist, PhD, MAcOM
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Complementary and Alternative Medicine (CAM) for Fibromyalgia

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