Tai Chi Mind-Body Therapy for Fibromyalgia

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00515008
First received: August 9, 2007
Last updated: February 9, 2016
Last verified: February 2016
Results First Received: November 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fibromyalgia
Interventions: Behavioral: Tai Chi Intervention
Behavioral: Control Intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We conducted the trial from July 2007 through May 2009 at Tufts Medical Center, a tertiary care academic hospital in Boston.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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


Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Tai Chi Group     Control Group  
STARTED     33     33  
Completed 12 Week Evaluation     32     29  
COMPLETED     30     29  
NOT COMPLETED     3     4  
Lost to Follow-up                 1                 0  
Declined                 0                 3  
Left the Boston Area                 1                 1  
Scheduling conflict                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tai Chi Group 12-week Tai Chi Program.: 12-week Tai Chi classes
Control Group 12-week Stretching and Wellness Education Program: Non-TC informational program
Total Total of all reporting groups

Baseline Measures
    Tai Chi Group     Control Group     Total  
Number of Participants  
[units: participants]
  33     33     66  
Age  
[units: years]
Mean (Standard Deviation)
  49.7  (11.8)     50.5  (10.5)     50  (11.2)  
Gender  
[units: participants]
     
Female     28     29     57  
Male     5     4     9  
Region of Enrollment  
[units: participants]
     
United States     33     33     66  
FIQ score [1]
[units: units on a scale]
Mean (Standard Deviation)
  62.9  (15.5)     68  (11)     65.5  (13.3)  
Patient’s global assessment score [2]
[units: units on a scale]
Mean (Standard Deviation)
  5.8  (2.3)     6.3  (1.8)     6.1  (2.1)  
Physician’s global assessment score [3]
[units: units on a scale]
Mean (Standard Deviation)
  5.7  (1.9)     5.6  (2.4)     5.7  (2.2)  
PSQI score [4]
[units: units on a scale]
Mean (Standard Deviation)
  13.9  (3.1)     13.5  (3.7)     13.7  (3.4)  
6-Minute walk test  
[units: yards]
Mean (Standard Deviation)
  522.1  (102.7)     501.2  (106.6)     511.7  (104.7)  
Body-mass index  
[units: kg/m^2]
Mean (Standard Deviation)
  33.9  (8.9)     31.5  (7.4)     32.7  (8.2)  
SF-36 score- Physical component [5]
[units: units on a scale]
Mean (Standard Deviation)
  28.5  (8.4)     28.0  (7.8)     28.3  (8.1)  
SF-36 score- Mental component [6]
[units: units on a scale]
Mean (Standard Deviation)
  42.6  (12.2)     37.8  (10.5)     40.2  (11.4)  
CES-D score [7]
[units: units on a scale]
Mean (Standard Deviation)
  22.6  (9.2)     27.8  (9.2)     25.2  (9.2)  
CPSS score [8]
[units: units on a scale]
Mean (Standard Deviation)
  5.2  (1.9)     4.6  (2.2)     4.9  (2.1)  
Outcome Expectations for Exercise score [9]
[units: units on a scale]
Mean (Standard Deviation)
  3.7  (0.8)     3.9  (0.7)     3.8  (0.8)  
High School or Higher Education  
[units: participants]
  31     30     61  
Duration of fibromyalgia-related pain — yr  
[units: years]
Mean (Standard Deviation)
  11.8  (6.9)     10.0  (7.2)     10.9  (7.1)  
White race  
[units: participants]
  20     17     37  
[1] 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.
[2] 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).
[3] 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).
[4] 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)
[5] 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)
[6] 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)
[7] 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.
[8] 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).
[9] 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.



  Outcome Measures
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1.  Primary:   Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score   [ Time Frame: wks 12 ]

2.  Secondary:   Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity   [ Time Frame: Wks 12 ]

3.  Secondary:   Mean Change From Baseline of Patient’s Global Assessment Score   [ Time Frame: 12 weeks ]

4.  Secondary:   Mean Change From Baseline PSQI Score   [ Time Frame: 12 weeks ]

5.  Secondary:   Mean Change From Baseline of 6-Minute Walk Test   [ Time Frame: 12 weeks ]

6.  Secondary:   Mean Change From Baseline SF-36 Score Physical Component   [ Time Frame: 12 weeks ]

7.  Secondary:   Mean Change From Baseline SF-36 Score Mental Component   [ Time Frame: 12 weeks ]

8.  Secondary:   Mean Change From Baseline CES-D Score   [ Time Frame: 12 weeks ]

9.  Secondary:   Mean Change From Baseline CPSS Score   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: cwang2@tuftsmedicalcenter.org


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00515008     History of Changes
Other Study ID Numbers: R21AT003621 ( US NIH Grant/Contract Award Number )
Study First Received: August 9, 2007
Results First Received: November 4, 2015
Last Updated: February 9, 2016
Health Authority: United States: Federal Government