FibromyalgiaNCT02053090
Complementary and Alternative Medicine (CAM) for Fibromyalgia
A study testing Group Education and Stretching and Group Acupuncture in people with Fibromyalgia, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Group Education and Stretching and Group Acupuncture
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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.
- Conditions
- Fibromyalgia
- Being tested
- Group Education and Stretching, Group Acupuncture
- Keywords
- Fibromyalgia, Group Acupuncture, Group Education with Stretching, Nociceptive Reflex Testing, Pain, Sleep, Fatigue
- Medical subject headings
- Fibromyalgia, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Education and StretchingBehavioural
Group AcupunctureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group Education with Stretching | Active comparator | 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. Receives: Behavioral: Group Education and Stretching |
| Group Acupuncture | Experimental | 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. Receives: Procedure: Group Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Participation Rate
Rates of treatment attendance in both arms
Measured: 10 weeks
Secondary outcomes (5)
Drop out rate
Drop out rates in both arms at weeks 10 and 14
Measured: 10 and 14 weeks
Completion of Evaluation Rates
Completion rates of questionnaires and examinations in both arms
Measured: Weeks 0, 5, 10 and 14
Fibromyalgia Impact Questionnaire Revised
Comparing overall score of the Fibromyalgia Impact Questionnaire - Revised between the two arms over time.
Measured: Weeks 0, 5, 10, and 14
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.
Measured: Weeks 0, 5, 10 and 14
Sleep Quality and Daily Activity
Sleep quality and daily activity will be measured using Actiwatch. Changes will be explored within individuals and between groups.
Measured: Weeks 0, 5, 10, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Mist, Oregon Health and Science University
- Investigators
- Scott D Mist, PhD, MAcOM, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053090
- Sponsor's protocol ID
- 1K23AT006392
- Status last verified
- Sep 2015
- First submitted
- 30 Jan 2014
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary and Alternative Medicine (CAM) for Fibromyalgia
- ClinicalTrials.gov ID
- NCT02053090
- Acronym / sponsor ID
- 1K23AT006392
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Group Acupuncture, Group Education with Stretching, Nociceptive Reflex Testing, Pain, Sleep, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Education with Stretching | Active comparator | Behavioral: Group Education and StretchingGroup 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. |
| Group Acupuncture | Experimental | Procedure: Group Acupuncture20 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Education and Stretching | Behavioural | Group Education with Stretching |
| Group Acupuncture | Procedure or surgery | Group Acupuncture |
Primary outcome
Treatment Participation Rate
Time frame: 10 weeks
Rates of treatment attendance in both arms
5 secondary outcomes
Drop out rate
Time frame: 10 and 14 weeks
Completion of Evaluation Rates
Time frame: Weeks 0, 5, 10 and 14
Fibromyalgia Impact Questionnaire Revised
Time frame: Weeks 0, 5, 10, and 14
Nociceptive Reflex Testing
Time frame: Weeks 0, 5, 10 and 14
Sleep Quality and Daily Activity
Time frame: Weeks 0, 5, 10, and 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott D Mist, PhD, MAcOM principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Education and Stretching and Group Acupuncture in people with Fibromyalgia, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Participation Rate (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015; AzTrials last refreshed its copy on 2 Nov 2026.