Trial Outcomes & Findings for Tai Chi Mind-Body Therapy for Fibromyalgia (NCT NCT00515008)
NCT ID: NCT00515008
Last Updated: 2016-03-08
Results Overview
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.
COMPLETED
NA
66 participants
wks 12
2016-03-08
Participant Flow
We conducted the trial from July 2007 through May 2009 at Tufts Medical Center, a tertiary care academic hospital in Boston.
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
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
Completed 12 Week Evaluation
|
32
|
29
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Declined
|
0
|
3
|
|
Overall Study
Left the Boston Area
|
1
|
1
|
|
Overall Study
Scheduling conflict
|
1
|
0
|
Baseline Characteristics
Tai Chi Mind-Body Therapy for Fibromyalgia
Baseline characteristics by cohort
| Measure |
Tai Chi Group
n=33 Participants
12-week Tai Chi Program.: 12-week Tai Chi classes
|
Control Group
n=33 Participants
12-week Stretching and Wellness Education Program: Non-TC informational program
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
50 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
33 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
FIQ score
|
62.9 units on a scale
STANDARD_DEVIATION 15.5 • n=5 Participants
|
68 units on a scale
STANDARD_DEVIATION 11 • n=7 Participants
|
65.5 units on a scale
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Patient's global assessment score
|
5.8 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 1.8 • n=7 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Physician's global assessment score
|
5.7 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
PSQI score
|
13.9 units on a scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
13.5 units on a scale
STANDARD_DEVIATION 3.7 • n=7 Participants
|
13.7 units on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
6-Minute walk test
|
522.1 yards
STANDARD_DEVIATION 102.7 • n=5 Participants
|
501.2 yards
STANDARD_DEVIATION 106.6 • n=7 Participants
|
511.7 yards
STANDARD_DEVIATION 104.7 • n=5 Participants
|
|
Body-mass index
|
33.9 kg/m^2
STANDARD_DEVIATION 8.9 • n=5 Participants
|
31.5 kg/m^2
STANDARD_DEVIATION 7.4 • n=7 Participants
|
32.7 kg/m^2
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
SF-36 score- Physical component
|
28.5 units on a scale
STANDARD_DEVIATION 8.4 • n=5 Participants
|
28.0 units on a scale
STANDARD_DEVIATION 7.8 • n=7 Participants
|
28.3 units on a scale
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
SF-36 score- Mental component
|
42.6 units on a scale
STANDARD_DEVIATION 12.2 • n=5 Participants
|
37.8 units on a scale
STANDARD_DEVIATION 10.5 • n=7 Participants
|
40.2 units on a scale
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
CES-D score
|
22.6 units on a scale
STANDARD_DEVIATION 9.2 • n=5 Participants
|
27.8 units on a scale
STANDARD_DEVIATION 9.2 • n=7 Participants
|
25.2 units on a scale
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
CPSS score
|
5.2 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Outcome Expectations for Exercise score
|
3.7 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
3.9 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
High School or Higher Education
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Duration of fibromyalgia-related pain - yr
|
11.8 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
10.0 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
10.9 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
White race
|
20 participants
n=5 Participants
|
17 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: wks 12Fibromyalgia 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.
Outcome measures
| Measure |
Tai Chi
n=33 Participants
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.
|
Control Group
n=33 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score
|
-27.8 units on a scale
Interval -33.8 to -21.8
|
-9.4 units on a scale
Interval -15.5 to -3.4
|
SECONDARY outcome
Timeframe: Wks 12Physicians' 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).
Outcome measures
| Measure |
Tai Chi
n=33 Participants
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.
|
Control Group
n=33 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity
|
-1.0 units on a scale
Interval -1.7 to -0.4
|
0.02 units on a scale
Interval -0.6 to 0.7
|
SECONDARY outcome
Timeframe: 12 weeksPatients' 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).
Outcome measures
| Measure |
Tai Chi
n=33 Participants
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.
|
Control Group
n=33 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline of Patient's Global Assessment Score
|
-2.5 units on a scale
Interval -3.3 to -1.7
|
-0.6 units on a scale
Interval -1.4 to 0.2
|
SECONDARY outcome
Timeframe: 12 weeksThe Pittsburgh Sleep Quality Index (PSQI) is a self-report measure of sleep quality(range, 0 to 21, with higher scores indicating worse sleep quality)
Outcome measures
| Measure |
Tai Chi
n=33 Participants
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.
|
Control Group
n=33 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline PSQI Score
|
-3.6 units on a scale
Interval -4.8 to -2.4
|
-0.7 units on a scale
Interval -1.9 to 0.5
|
SECONDARY outcome
Timeframe: 12 weeksOutcome measures
| Measure |
Tai Chi
n=33 Participants
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.
|
Control Group
n=33 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline of 6-Minute Walk Test
|
60.6 yards
Interval 37.9 to 83.3
|
16.3 yards
Interval -6.4 to 38.9
|
SECONDARY outcome
Timeframe: 12 weeksThe 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)
Outcome measures
| Measure |
Tai Chi
n=33 Participants
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.
|
Control Group
n=33 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline SF-36 Score Physical Component
|
8.5 units on a scale
Interval 5.7 to 11.3
|
1.4 units on a scale
Interval -1.5 to 4.2
|
SECONDARY outcome
Timeframe: 12 weeksThe 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)
Outcome measures
| Measure |
Tai Chi
n=33 Participants
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.
|
Control Group
n=33 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline SF-36 Score Mental Component
|
7.7 units on a scale
Interval 3.9 to 11.6
|
6.1 units on a scale
Interval 0.7 to 11.6
|
SECONDARY outcome
Timeframe: 12 weeksThe 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.
Outcome measures
| Measure |
Tai Chi
n=33 Participants
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.
|
Control Group
n=33 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline CES-D Score
|
-8.1 units on a scale
Interval -10.9 to -5.3
|
-2.3 units on a scale
Interval -5.1 to 0.6
|
SECONDARY outcome
Timeframe: 12 weeksThe 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 measures
| Measure |
Tai Chi
n=33 Participants
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.
|
Control Group
n=33 Participants
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.
|
|---|---|---|
|
Mean Change From Baseline CPSS Score
|
1.5 units on a scale
Interval 0.7 to 2.2
|
0.5 units on a scale
Interval -0.3 to 1.2
|
Adverse Events
Tai Chi Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place