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Tai Chi Mind-Body Therapy for Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00515008
Recruitment Status : Completed
First Posted : August 13, 2007
Results First Posted : March 8, 2016
Last Update Posted : March 8, 2016
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
American College of Rheumatology Research and Education Foundation
Information provided by (Responsible Party):
Tufts Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Fibromyalgia
Interventions Behavioral: Tai Chi Intervention
Behavioral: Control Intervention
Enrollment 66
Recruitment Details We conducted the trial from July 2007 through May 2009 at Tufts Medical Center, a tertiary care academic hospital in Boston.
Pre-assignment Details

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

Arm/Group Title Tai Chi Group Control Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 33 33
Completed 12 Week Evaluation 32 29
Completed 30 29
Not Completed 3 4
Reason Not Completed
Lost to Follow-up             1             0
Declined             0             3
Left the Boston Area             1             1
Scheduling conflict             1             0
Arm/Group Title Tai Chi Group Control Group Total
Hide Arm/Group Description 12-week Tai Chi Program.: 12-week Tai Chi classes 12-week Stretching and Wellness Education Program: Non-TC informational program Total of all reporting groups
Overall Number of Baseline Participants 33 33 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 33 participants 66 participants
49.7  (11.8) 50.5  (10.5) 50  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
Female
28
  84.8%
29
  87.9%
57
  86.4%
Male
5
  15.2%
4
  12.1%
9
  13.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 33 participants 66 participants
33 33 66
FIQ score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 33 participants 66 participants
62.9  (15.5) 68  (11) 65.5  (13.3)
[1]
Measure Description: 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.
Patient’s global assessment score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 33 participants 66 participants
5.8  (2.3) 6.3  (1.8) 6.1  (2.1)
[1]
Measure Description: 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).
Physician’s global assessment score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 33 participants 66 participants
5.7  (1.9) 5.6  (2.4) 5.7  (2.2)
[1]
Measure Description: 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).
PSQI score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 33 participants 66 participants
13.9  (3.1) 13.5  (3.7) 13.7  (3.4)
[1]
Measure Description: 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)
6-Minute walk test  
Mean (Standard Deviation)
Unit of measure:  Yards
Number Analyzed 33 participants 33 participants 66 participants
522.1  (102.7) 501.2  (106.6) 511.7  (104.7)
Body-mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 33 participants 33 participants 66 participants
33.9  (8.9) 31.5  (7.4) 32.7  (8.2)
SF-36 score- Physical component   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 33 participants 66 participants
28.5  (8.4) 28.0  (7.8) 28.3  (8.1)
[1]
Measure Description: 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)
SF-36 score- Mental component   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 33 participants 66 participants
42.6  (12.2) 37.8  (10.5) 40.2  (11.4)
[1]
Measure Description: 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)
CES-D score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 33 participants 66 participants
22.6  (9.2) 27.8  (9.2) 25.2  (9.2)
[1]
Measure Description: 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.
CPSS score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 33 participants 66 participants
5.2  (1.9) 4.6  (2.2) 4.9  (2.1)
[1]
Measure Description: 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).
Outcome Expectations for Exercise score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 33 participants 33 participants 66 participants
3.7  (0.8) 3.9  (0.7) 3.8  (0.8)
[1]
Measure Description: 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.
High School or Higher Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
31 30 61
Duration of fibromyalgia-related pain — yr  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 33 participants 66 participants
11.8  (6.9) 10.0  (7.2) 10.9  (7.1)
White race  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
20 17 37
1.Primary Outcome
Title Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score
Hide Description 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.
Time Frame wks 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Control Group
Hide Arm/Group Description:

The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. 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 tech- niques. In subsequent sessions, participants prac- ticed 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 inter- vention 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.

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.

Overall Number of Participants Analyzed 33 33
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-27.8
(-33.8 to -21.8)
-9.4
(-15.5 to -3.4)
2.Secondary Outcome
Title Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity
Hide Description 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).
Time Frame Wks 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Control Group
Hide Arm/Group Description:

The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. 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 tech- niques. In subsequent sessions, participants prac- ticed 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 inter- vention 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.

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.

Overall Number of Participants Analyzed 33 33
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-1.0
(-1.7 to -0.4)
0.02
(-0.6 to 0.7)
3.Secondary Outcome
Title Mean Change From Baseline of Patient’s Global Assessment Score
Hide Description 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).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Control Group
Hide Arm/Group Description:
The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. 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 tech- niques. In subsequent sessions, participants prac- ticed 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 inter- vention 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.

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.

Overall Number of Participants Analyzed 33 33
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.5
(-3.3 to -1.7)
-0.6
(-1.4 to 0.2)
4.Secondary Outcome
Title Mean Change From Baseline PSQI Score
Hide Description 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)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Group Control Group
Hide Arm/Group Description:
12-week Tai Chi Program.: 12-week Tai Chi classes
12-week Stretching and Wellness Education Program: Non-TC informational program
Overall Number of Participants Analyzed 33 33
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-3.6
(-4.8 to -2.4)
-0.7
(-1.9 to 0.5)
5.Secondary Outcome
Title Mean Change From Baseline of 6-Minute Walk Test
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Group Control Group
Hide Arm/Group Description:
12-week Tai Chi Program.: 12-week Tai Chi classes
12-week Stretching and Wellness Education Program: Non-TC informational program
Overall Number of Participants Analyzed 33 33
Mean (95% Confidence Interval)
Unit of Measure: yards
60.6
(37.9 to 83.3)
16.3
(-6.4 to 38.9)
6.Secondary Outcome
Title Mean Change From Baseline SF-36 Score Physical Component
Hide Description 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)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Group Control Group
Hide Arm/Group Description:
12-week Tai Chi Program.: 12-week Tai Chi classes
12-week Stretching and Wellness Education Program: Non-TC informational program
Overall Number of Participants Analyzed 33 33
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
8.5
(5.7 to 11.3)
1.4
(-1.5 to 4.2)
7.Secondary Outcome
Title Mean Change From Baseline SF-36 Score Mental Component
Hide Description 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)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Group Control Group
Hide Arm/Group Description:
12-week Tai Chi Program.: 12-week Tai Chi classes
12-week Stretching and Wellness Education Program: Non-TC informational program
Overall Number of Participants Analyzed 33 33
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
7.7
(3.9 to 11.6)
6.1
(0.7 to 11.6)
8.Secondary Outcome
Title Mean Change From Baseline CES-D Score
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Group Control Group
Hide Arm/Group Description:
12-week Tai Chi Program.: 12-week Tai Chi classes
12-week Stretching and Wellness Education Program: Non-TC informational program
Overall Number of Participants Analyzed 33 33
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-8.1
(-10.9 to -5.3)
-2.3
(-5.1 to 0.6)
9.Secondary Outcome
Title Mean Change From Baseline CPSS Score
Hide Description 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).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tai Chi Group Control Group
Hide Arm/Group Description:
12-week Tai Chi Program.: 12-week Tai Chi classes
12-week Stretching and Wellness Education Program: Non-TC informational program
Overall Number of Participants Analyzed 33 33
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.5
(0.7 to 2.2)
0.5
(-0.3 to 1.2)
Time Frame 24 months
Adverse Event Reporting Description 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.
 
Arm/Group Title Tai Chi Group Control Group
Hide Arm/Group Description 12-week Tai Chi Program.: 12-week Tai Chi classes 12-week Stretching and Wellness Education Program: Non-TC informational program
All-Cause Mortality
Tai Chi Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tai Chi Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tai Chi Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: chenchen wang
Organization: tufts medical center
Phone: 617-636-3251
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00515008     History of Changes
Other Study ID Numbers: R21AT003621 ( U.S. NIH Grant/Contract )
R21AT003621 ( U.S. NIH Grant/Contract )
First Submitted: August 9, 2007
First Posted: August 13, 2007
Results First Submitted: November 4, 2015
Results First Posted: March 8, 2016
Last Update Posted: March 8, 2016