FibromyalgiaNCT00515008
Tai Chi Mind-Body Therapy for Fibromyalgia
A study testing Tai Chi Intervention in people with Fibromyalgia, run by Tufts Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to obtain preliminary data on the effects of Tai Chi on musculoskeletal pain, fatigue, sleep quality, psychological distress, physical performance,and health status in 60 patients with fibromyalgia. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Tai Chi Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 or older
- Fulfills the American College of Rheumatology (ACR) 1990 diagnostic criteria for FM. (1) a history of widespread musculoskeletal pain on the right and left sides of the body as well as above and below the waist for a minimum duration of 3 months, and (2) pain in 11 or more of 18 specific tender points with moderate or greater tenderness reported upon digital palpation.
- Physically able to participate in both the Tai Chi and stretching and education programs according to their primary care physician.
- Willing to complete the 12-week study, including twice-a-week Tai Chi or stretching and education sessions
Who cannot join
- Prior experience with Tai Chi or other similar types of Complementary and Alternative Medicine in the past 6 months such as Qi gong and yoga since these share some of the principles of Tai Chi
- Any health condition limiting the ability to participate as determined by a primary care physician
- Any other diagnosed medical condition that is known to contribute to FM symptomatology that is not under adequate control or cannot be expected to remain under adequate control for the study period such as thyroid disease, inflammatory arthritis, scleroderma, systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis, myositis and vasculitis or Sjogren's syndrome
- Not English-Speaking
- Positive pregnancy test or planning pregnancy within the study period
- Inability to pass the Mini-Mental Status examination (score below 24)
- Enrollment in any other clinical trial within the last 30 days
- Plan to permanently relocate from the region during the trial period
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Medical Center, Division of Rheumatology
Boston, Massachusetts, 02111
About this study
Official title: Tai Chi Mind-Body Therapy for Fibromyalgia: a Pilot Single-Blind Randomized Controlled Trial.
The purpose of this study is to obtain preliminary data on the effects of Tai Chi on musculoskeletal pain, fatigue, sleep quality, psychological distress, physical performance,and health status in 60 patients with fibromyalgia.
Read the detailed description
Fibromyalgia (FM) is a common, complex chronic condition marked by diffuse musculoskeletal pain, fatigue, functional impairment, disability, and psychological distress that affects 6-10 million people in the United States (US). There are currently no satisfactory pharmacological or non-pharmacological treatments for FM. New cost-effective strategies that reduce musculoskeletal pain and improve emotional and physical functioning as well as quality of life in people with FM are urgently needed.
Tai Chi is a traditional Chinese discipline with both physical and mental components that appears to benefit a variety of chronic conditions. The physical component provides exercise that is consistent with that recommended for FM (muscle conditioning and aerobic cardiovascular exercise), while the mental component has the potential to improve psychological well-being. These effects are especially pertinent for the treatment of individuals with FM.
This is a pilot randomized controlled trial of Tai Chi for fibromyalgia. We plan to enroll 60 patients with fibromyalgia over a two year period. Participants are randomized to either a Tai Chi program or an attention control intervention. Assessments are performed at baseline, week 12 and week 24. This study will provide preliminary data on the potential acceptability and safety of Tai Chi for FM and will help guide the design of a future large-scale study of the efficacy of this alternative therapy.
- Conditions
- Fibromyalgia
- Being tested
- Tai Chi Intervention, Control Intervention
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi InterventionBehavioural
The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 minutes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and techniques. In subsequent sessions, participants practiced 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the intervention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks.
Control InterventionBehavioural
Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyalgia, including the diagnostic criteria; coping strategies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physical and mental health; exercise; and wellness and lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching exercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Intervention | Experimental | The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 minutes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and techniques. In subsequent sessions, participants practiced 10 forms from the classic Yang style of tai chi 18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the intervention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks. Receives: Behavioral: Tai Chi Intervention |
| Control Intervention | Placebo comparator | Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyalgia, including the diagnostic criteria; coping strategies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physical and mental health; exercise; and wellness and lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching exercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day. Receives: Behavioral: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score
Fibromyalgia Impact Questionnaire (FIQ) is a well-validated, multidimensional measure of the overall severity of fibromyalgia as rated by patients. Categories include the intensity of pain, physical functioning, fatigue, morning tiredness, stiffness, depression, anxiety, job difficulty, and overall well-being.21 The total score ranges from 0 to 100, with higher scores indicating more severe symptoms.
Measured: wks 12
Secondary outcomes (8)
Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity
Physicians' global assessment score was assessed separately by the study physician, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).
Measured: Wks 12
Mean Change From Baseline of Patient's Global Assessment Score
Patients' global assessment score was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).
Measured: 12 weeks
Mean Change From Baseline PSQI Score
The Pittsburgh Sleep Quality Index (PSQI) is a self-report measure of sleep quality(range, 0 to 21, with higher scores indicating worse sleep quality)
Measured: 12 weeks
Mean Change From Baseline of 6-Minute Walk Test
Measured: 12 weeks
Mean Change From Baseline SF-36 Score Physical Component
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)
Measured: 12 weeks
Mean Change From Baseline SF-36 Score Mental Component
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)
Measured: 12 weeks
Mean Change From Baseline CES-D Score
The Center for Epidemiologic Studies (CES-D) Depression Scale (range, 0 to 60, with higher scores indicating more severe depression), is a self-report measure of depressive symptoms.
Measured: 12 weeks
Mean Change From Baseline CPSS Score
The Chronic Pain Self-Efficacy Scale (CPSS) is a self-report score measuring self-efficacy with respect to chronic pain (range, 1 to 10, with higher scores indicating greater self-efficacy).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), American College of Rheumatology Research and Education Foundation
- Responsible party
- Sponsor
- Investigators
- Chenchen Wang, MD, MSc, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515008
- Sponsor's protocol ID
- R21AT003621
- Other IDs
- R21AT003621
- Status last verified
- Feb 2016
- First submitted
- 9 Aug 2007
- Last updated
- 8 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wang C, Collet JP, Lau J. The effect of Tai Chi on health outcomes in patients with chronic conditions: a systematic review. Arch Intern Med. 2004 Mar 8;164(5):493-501. doi: 10.1001/archinte.164.5.493.
PubMed 15006825Wang C, Roubenoff R, Lau J, Kalish R, Schmid CH, Tighiouart H, Rones R, Hibberd PL. Effect of Tai Chi in adults with rheumatoid arthritis. Rheumatology (Oxford). 2005 May;44(5):685-7. doi: 10.1093/rheumatology/keh572. Epub 2005 Mar 1. No abstract available.
PubMed 15741197Wang C. Tai Chi improves pain and functional status in adults with rheumatoid arthritis: results of a pilot single-blinded randomized controlled trial. Med Sport Sci. 2008;52:218-229. doi: 10.1159/000134302.
PubMed 18487901Wang C, Schmid CH, Rones R, Kalish R, Yinh J, Goldenberg DL, Lee Y, McAlindon T. A randomized trial of tai chi for fibromyalgia. N Engl J Med. 2010 Aug 19;363(8):743-54. doi: 10.1056/NEJMoa0912611.
PubMed 20818876
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi Mind-Body Therapy for Fibromyalgia: a Pilot Single-Blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00515008
- Acronym / sponsor ID
- R21AT003621
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), American College of Rheumatology Research and Education Foundation
- Study start
- Jun 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Aug 2007 (estimated)
- Results
- Posted 8 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to obtain preliminary data on the effects of Tai Chi on musculoskeletal pain, fatigue, sleep quality, psychological distress, physical performance,and health status in 60 patients with fibromyalgia.
Detailed description
Fibromyalgia (FM) is a common, complex chronic condition marked by diffuse musculoskeletal pain, fatigue, functional impairment, disability, and psychological distress that affects 6-10 million people in the United States (US). There are currently no satisfactory pharmacological or non-pharmacological treatments for FM. New cost-effective strategies that reduce musculoskeletal pain and improve emotional and physical functioning as well as quality of life in people with FM are urgently needed.
Tai Chi is a traditional Chinese discipline with both physical and mental components that appears to benefit a variety of chronic conditions. The physical component provides exercise that is consistent with that recommended for FM (muscle conditioning and aerobic cardiovascular exercise), while the mental component has the potential to improve psychological well-being. These effects are especially pertinent for the treatment of individuals with FM.
This is a pilot randomized controlled trial of Tai Chi for fibromyalgia. We plan to enroll 60 patients with fibromyalgia over a two year period. Participants are randomized to either a Tai Chi program or an attention control intervention. Assessments are performed at baseline, week 12 and week 24. This study will provide preliminary data on the potential acceptability and safety of Tai Chi for FM and will help guide the design of a future large-scale study of the efficacy of this alternative therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Intervention | Experimental | Behavioral: Tai Chi InterventionThe tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 minutes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and techniques. In subsequent sessions, participants practiced 10 forms from the classic Yang style of tai chi 18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the intervention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks. |
| Control Intervention | Placebo comparator | Behavioral: Control InterventionOur wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyalgia, including the diagnostic criteria; coping strategies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physical and mental health; exercise; and wellness and lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching exercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21 or older
- Fulfills the American College of Rheumatology (ACR) 1990 diagnostic criteria for FM. (1) a history of widespread musculoskeletal pain on the right and left sides of the body as well as above and below the waist for a minimum duration of 3 months, and (2) pain in 11 or more of 18 specific tender points with moderate or greater tenderness reported upon digital palpation.
- Physically able to participate in both the Tai Chi and stretching and education programs according to their primary care physician.
- Willing to complete the 12-week study, including twice-a-week Tai Chi or stretching and education sessions
Key exclusion criteria (8 listed)
- Prior experience with Tai Chi or other similar types of Complementary and Alternative Medicine in the past 6 months such as Qi gong and yoga since these share some of the principles of Tai Chi
- Any health condition limiting the ability to participate as determined by a primary care physician
- Any other diagnosed medical condition that is known to contribute to FM symptomatology that is not under adequate control or cannot be expected to remain under adequate control for the study period such as thyroid disease, inflammatory arthritis, scleroderma, systemic lupus erythematosus, systemic sclerosis, rheumatoid arthritis, myositis and vasculitis or Sjogren's syndrome
- Not English-Speaking
- Positive pregnancy test or planning pregnancy within the study period
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 |
|---|---|---|
| Tai Chi InterventionThe tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 minutes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and techniques. In subsequent sessions, participants practiced 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the intervention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks. | Behavioural | Tai Chi Intervention |
| Control InterventionOur wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyalgia, including the diagnostic criteria; coping strategies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physical and mental health; exercise; and wellness and lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching exercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day. | Behavioural | Control Intervention |
Primary outcome
Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score
Time frame: wks 12
Fibromyalgia Impact Questionnaire (FIQ) is a well-validated, multidimensional measure of the overall severity of fibromyalgia as rated by patients. Categories include the intensity of pain, physical functioning, fatigue, morning tiredness, stiffness, depression, anxiety, job difficulty, and overall well-being.21 The total score ranges from 0 to 100, with higher scores indicating more severe symptoms.
8 secondary outcomes
Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity
Time frame: Wks 12
Mean Change From Baseline of Patient's Global Assessment Score
Time frame: 12 weeks
Mean Change From Baseline PSQI Score
Time frame: 12 weeks
Mean Change From Baseline of 6-Minute Walk Test
Time frame: 12 weeks
Mean Change From Baseline SF-36 Score Physical Component
Time frame: 12 weeks
Mean Change From Baseline SF-36 Score Mental Component
Time frame: 12 weeks
Mean Change From Baseline CES-D Score
Time frame: 12 weeks
Mean Change From Baseline CPSS Score
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15006825Wang C, Collet JP, Lau J. The effect of Tai Chi on health outcomes in patients with chronic conditions: a systematic review. Arch Intern Med. 2004 Mar 8;164(5):493-501. doi: 10.1001/archinte.164.5.493.
- Background: PubMed 15741197Wang C, Roubenoff R, Lau J, Kalish R, Schmid CH, Tighiouart H, Rones R, Hibberd PL. Effect of Tai Chi in adults with rheumatoid arthritis. Rheumatology (Oxford). 2005 May;44(5):685-7. doi: 10.1093/rheumatology/keh572. Epub 2005 Mar 1. No abstract available.
- Background: PubMed 18487901Wang C. Tai Chi improves pain and functional status in adults with rheumatoid arthritis: results of a pilot single-blinded randomized controlled trial. Med Sport Sci. 2008;52:218-229. doi: 10.1159/000134302.
- Derived from this study: PubMed 20818876Wang C, Schmid CH, Rones R, Kalish R, Yinh J, Goldenberg DL, Lee Y, McAlindon T. A randomized trial of tai chi for fibromyalgia. N Engl J Med. 2010 Aug 19;363(8):743-54. doi: 10.1056/NEJMoa0912611.
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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.
Chenchen Wang, MD, MSc principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Intervention in people with Fibromyalgia, run by Tufts Medical Center 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 4 inclusion and 8 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 8 Mar 2016. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 8 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (time frame: wks 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00515008, which also lists 4 linked publications.
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 8 Mar 2016.