Fibromyalgia
Conditions
Brief 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.
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.
Interventions
BEHAVIORALTai Chi Intervention
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.
BEHAVIORALControl Intervention
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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
American College of Rheumatology Research and Education Foundation
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline of Patient's Global Assessment Score | 12 weeks | 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 Change From Baseline PSQI Score | 12 weeks | 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 Change From Baseline of 6-Minute Walk Test | 12 weeks | — |
| Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity | Wks 12 | 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 Change From Baseline SF-36 Score Mental Component | 12 weeks | 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 Change From Baseline CES-D Score | 12 weeks | 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 Change From Baseline CPSS Score | 12 weeks | 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 Change From Baseline SF-36 Score Physical Component | 12 weeks | 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) |
Countries
United States
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| Tai Chi Group 12-week Tai Chi Program.: 12-week Tai Chi classes | 33 |
| Control Group 12-week Stretching and Wellness Education Program: Non-TC informational program | 33 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Declined | 0 | 3 |
| Overall Study | Left the Boston Area | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Scheduling conflict | 1 | 0 |
Baseline characteristics
| Characteristic | Tai Chi Group | Total | Control Group |
|---|---|---|---|
| 6-Minute walk test | 522.1 yards STANDARD_DEVIATION 102.7 | 511.7 yards STANDARD_DEVIATION 104.7 | 501.2 yards STANDARD_DEVIATION 106.6 |
| Age, Continuous | 49.7 years STANDARD_DEVIATION 11.8 | 50 years STANDARD_DEVIATION 11.2 | 50.5 years STANDARD_DEVIATION 10.5 |
| Body-mass index | 33.9 kg/m^2 STANDARD_DEVIATION 8.9 | 32.7 kg/m^2 STANDARD_DEVIATION 8.2 | 31.5 kg/m^2 STANDARD_DEVIATION 7.4 |
| CES-D score | 22.6 units on a scale STANDARD_DEVIATION 9.2 | 25.2 units on a scale STANDARD_DEVIATION 9.2 | 27.8 units on a scale STANDARD_DEVIATION 9.2 |
| CPSS score | 5.2 units on a scale STANDARD_DEVIATION 1.9 | 4.9 units on a scale STANDARD_DEVIATION 2.1 | 4.6 units on a scale STANDARD_DEVIATION 2.2 |
| Duration of fibromyalgia-related pain - yr | 11.8 years STANDARD_DEVIATION 6.9 | 10.9 years STANDARD_DEVIATION 7.1 | 10.0 years STANDARD_DEVIATION 7.2 |
| FIQ score | 62.9 units on a scale STANDARD_DEVIATION 15.5 | 65.5 units on a scale STANDARD_DEVIATION 13.3 | 68 units on a scale STANDARD_DEVIATION 11 |
| High School or Higher Education | 31 participants | 61 participants | 30 participants |
| Outcome Expectations for Exercise score | 3.7 units on a scale STANDARD_DEVIATION 0.8 | 3.8 units on a scale STANDARD_DEVIATION 0.8 | 3.9 units on a scale STANDARD_DEVIATION 0.7 |
| Patient's global assessment score | 5.8 units on a scale STANDARD_DEVIATION 2.3 | 6.1 units on a scale STANDARD_DEVIATION 2.1 | 6.3 units on a scale STANDARD_DEVIATION 1.8 |
| Physician's global assessment score | 5.7 units on a scale STANDARD_DEVIATION 1.9 | 5.7 units on a scale STANDARD_DEVIATION 2.2 | 5.6 units on a scale STANDARD_DEVIATION 2.4 |
| PSQI score | 13.9 units on a scale STANDARD_DEVIATION 3.1 | 13.7 units on a scale STANDARD_DEVIATION 3.4 | 13.5 units on a scale STANDARD_DEVIATION 3.7 |
| Region of Enrollment United States | 33 participants | 66 participants | 33 participants |
| Sex: Female, Male Female | 28 Participants | 57 Participants | 29 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 4 Participants |
| SF-36 score- Mental component | 42.6 units on a scale STANDARD_DEVIATION 12.2 | 40.2 units on a scale STANDARD_DEVIATION 11.4 | 37.8 units on a scale STANDARD_DEVIATION 10.5 |
| SF-36 score- Physical component | 28.5 units on a scale STANDARD_DEVIATION 8.4 | 28.3 units on a scale STANDARD_DEVIATION 8.1 | 28.0 units on a scale STANDARD_DEVIATION 7.8 |
| White race | 20 participants | 37 participants | 17 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
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.
Time frame: wks 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tai Chi | Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score | -27.8 units on a scale |
| Control Group | Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score | -9.4 units on a scale |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tai Chi | Mean Change From Baseline CES-D Score | -8.1 units on a scale |
| Control Group | Mean Change From Baseline CES-D Score | -2.3 units on a scale |
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).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tai Chi | Mean Change From Baseline CPSS Score | 1.5 units on a scale |
| Control Group | Mean Change From Baseline CPSS Score | 0.5 units on a scale |
Secondary
Mean Change From Baseline of 6-Minute Walk Test
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tai Chi | Mean Change From Baseline of 6-Minute Walk Test | 60.6 yards |
| Control Group | Mean Change From Baseline of 6-Minute Walk Test | 16.3 yards |
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).
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tai Chi | Mean Change From Baseline of Patient's Global Assessment Score | -2.5 units on a scale |
| Control Group | Mean Change From Baseline of Patient's Global Assessment Score | -0.6 units on a scale |
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).
Time frame: Wks 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tai Chi | Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity | -1.0 units on a scale |
| Control Group | Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity | 0.02 units on a scale |
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)
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tai Chi | Mean Change From Baseline PSQI Score | -3.6 units on a scale |
| Control Group | Mean Change From Baseline PSQI Score | -0.7 units on a scale |
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)
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tai Chi | Mean Change From Baseline SF-36 Score Mental Component | 7.7 units on a scale |
| Control Group | Mean Change From Baseline SF-36 Score Mental Component | 6.1 units on a scale |
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)
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tai Chi | Mean Change From Baseline SF-36 Score Physical Component | 8.5 units on a scale |
| Control Group | Mean Change From Baseline SF-36 Score Physical Component | 1.4 units on a scale |