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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT003621 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| American College of Rheumatology Research and Education Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tai Chi Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | wks 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Wks 12 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Chenchen Wang, MD, MSc | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center, Division of Rheumatology | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15006825 | Background | 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. | |
| 15741197 | Background | Wang 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. |
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90 Underwent baseline evaluation. 24 Were excluded:
1 Did not have fibromyalgia 4 Were physically unable to participate 17 Had scheduling conflicts
1 Was currently practicing tai chi
1 Had preexisting medical condition
We conducted the trial from July 2007 through May 2009 at Tufts Medical Center, a tertiary care academic hospital in Boston.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tai Chi Group | 12-week Tai Chi Program.: 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 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. |
| FG001 | Control Group | 12-week Stretching and Wellness Education Program: Non-TC informational program. Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks. 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tai Chi Group | 12-week Tai Chi Program.: 12-week Tai Chi classes |
| BG001 | Control Group | 12-week Stretching and Wellness Education Program: Non-TC informational program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | wks 12 |
|
24 months
We monitored adverse events, using a standard case report form at each visit. This form included a description of all unanticipated benefits and undesirable experiences, particularly falls and exacerbations of fibromyalgia symptoms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tai Chi Group | 12-week Tai Chi Program.: 12-week Tai Chi classes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| chenchen wang | tufts medical center | 617-636-3251 | cwang2@tuftsmedicalcenter.org |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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|
| Control Intervention | Behavioral | 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. |
|
| 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). |
| 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) | 12 weeks |
| Mean Change From Baseline of 6-Minute Walk Test | 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) | 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) | 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. | 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). | 12 weeks |
| 18487901 | Background | Wang 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. |
| 20818876 | Derived | Wang 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. |
| Left the Boston Area |
|
| Scheduling conflict |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| FIQ 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. | Mean | Standard Deviation | units on a scale |
|
| 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). | Mean | Standard Deviation | units on a scale |
|
| Physician's global assessment score | 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). | Mean | Standard Deviation | units on a scale |
|
| 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) | Mean | Standard Deviation | units on a scale |
|
| 6-Minute walk test | Mean | Standard Deviation | yards |
|
| Body-mass index | Mean | Standard Deviation | kg/m^2 |
|
| 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) | Mean | Standard Deviation | units on a scale |
|
| 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) | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| 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). | Mean | Standard Deviation | units on a scale |
|
| Outcome Expectations for Exercise score | The Outcome Expectations for Exercise Scale (range, 1 to 5, with 1 indicating no expectations for exercise and 5 the highest expectations for exercise) is a self-report measure of outcome expectations for exercise. | Mean | Standard Deviation | units on a scale |
|
| High School or Higher Education | Number | participants |
|
| Duration of fibromyalgia-related pain - yr | Mean | Standard Deviation | years |
|
| White race | Number | participants |
|
| OG001 | Control Group | 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 fibromyal- gia, including the diagnostic criteria; coping strat- egies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physi- cal and mental health; exercise; and wellness and lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching ex- ercises 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. |
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | Wks 12 |
|
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
|
|
| Secondary | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
|
|
| Secondary | Mean Change From Baseline of 6-Minute Walk Test | Posted | Mean | 95% Confidence Interval | yards | 12 weeks |
|
|
|
| Secondary | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
|
|
| Secondary | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
|
|
| Secondary | 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). | Posted | Mean | 95% Confidence Interval | units on a scale | 12 weeks |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Control Group | 12-week Stretching and Wellness Education Program: Non-TC informational program | 0 | 33 | 0 | 33 |
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| D009422 |
| Nervous System Diseases |