Knee Osteoarthritis
Conditions
Keywords
Knee, Knee osteoarthritis, osteoarthritis, Knee pain, Tai Chi, Physical Therapy, mind-body exercise
Brief summary
We will conduct a large randomized controlled trial comparing the effectiveness and cost-effectiveness of Tai Chi mind-body exercise and standard-of-care Physical Therapy for Knee Osteoarthritis.
Detailed description
Osteoarthritis (OA) causes pain and long-term disability, and the public health impact will increase as the population ages. In addition to inconsistent effectiveness, current treatments such as nonsteroidal anti-inflammatory drugs, knee replacement, and physical therapy may be expensive, result in serious adverse effects, reduce physical function, and fail to improve mental well-being. Finding effective treatments to maintain function and quality of life in OA patients is one of the national priorities identified this year by the Institute of Medicine. We propose to conduct the first comparative effectiveness and cost-effectiveness trial of Tai Chi vs. physical therapy (PT) in a large symptomatic Knee OA population. A single-blind, randomized, controlled trial of Tai Chi vs. Physical Therapy will be conducted in 180 patients who meet the American College of Rheumatology criteria for Knee OA. Patients will be randomized to 12 weeks of treatment with Tai Chi (2x/week) or Standard Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorous supervised home exercise) with 24 and 52 week follow-ups.
Interventions
BEHAVIORALTai Chi
12 weeks of Tai Chi
BEHAVIORALPhysical Therapy
6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 40 years and older * American College of Rheumatology criteria for symptomatic Knee OA: Pain on more than half the days of the past month during at least one of the following activities: walking, going up or down stairs, standing upright, or lying in bed at night;101 radiographic evidence of grade I-III tibiofemoral or patellofemoral OA: defined as the presence of osteophytes in the tibiofemoral compartment and /or the patellofemoral compartment, as assessed on standing anterior/posterior and lateral views101 * WOMAC pain subscale score \>= 40 (visual analog version) on at least 1 of 5 questions (range 0 to 100 each) * Clinical examination confirming knee pain or discomfort or instability referable to the knee joint * Physically able to participate in both the Tai Chi and Standard PT programs * Willing to undergo testing and intervention procedures and 1.willing to abstain from Tai Chi until completion of the program, if randomized to Standard PT regimen. 2. willing to abstain from Standard PT regimen until completion of the program, if randomized to Tai Chi
Exclusion criteria
* Prior experience with physical therapy, Tai Chi or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong and yoga since these share some of the principles of Tai Chi. * Serious medical conditions limiting the ability and safety to participate in either the Tai Chi or Standard PT regimen programs as determined by primary care physicians; these include dementia, neurological disease, symptomatic heart or vascular disease (angina, peripheral vascular disease, congestive heart failure), severe hypertension, recent stroke, severe insulin-dependent diabetes mellitus, psychiatric disease, renal disease, liver disease, active cancer and anemia * Any intra-articular steroid injections in the previous 3 months or reconstructive surgery on the affected knee * Any intra-articular Synvisc or Hyalgan injections in the previous 6 months * Inability to pass the Mini-Mental Status examination (with a score below 24)102 * Inability to walk without a cane or other assistive device 100% of the time during the baseline assessments * Enrollment in any other clinical trial within the last 30 days * Plan to permanently relocate from the region during the trial period * Positive pregnancy test or planning pregnancy within the study period * Not English-Speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks | From Week 0 to Week 12 | The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 Minute Walk | From Week 0, to Week 12, or to week 24, or to week 52 | The 6 minute Walk Test is a measure of functional exercise capacity. Participants are asked to walk as far as possible within a six-minute period, and the distance covered at the end is noted and recorded. |
| Change in 20 Meter Walk Test | From Week 0, to Week 12, or to week 24, or to week 52 | the 20-meter walk test is a performance measurement of walking ability (measured as the total number of seconds it takes to walk 20 meters); lower scores indicate improved walking ability |
| Change in Patient Global VAS | From Week 0, to Week 12, or to week 24, or to week 52 | Patients' global assessment score (Patient Global VAS) 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). |
| Change in Beck II Depression Inventory | From Week 0, to Week 12, or to week 24, or to week 52 | Beck II Depression Inventory (BDI), second edition, is a 21-question, validated, self-report instrument that measures the severity of depressive symptoms. Total scores range from 0-63, and higher scores reflect greater depressive symptoms. BDI scores ranging from 0-13 represent minimal depressive symptoms; scores from 14-19 are mild; scores from 20-28 are moderate; and scores from 29-63 represent severe depressive symptoms. |
| Change in Medical Outcomes Short Form-36 PCS | From Week 0, to Week 12, or to week 24, or to week 52 | The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status) |
| Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS) | From Week 0, to Week 12, or to week 24, or to week 52 | The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component Score (MCS) is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status) |
| Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function | From Week 0, to Week 12, or to week 24, or to week 52 | The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease. |
| Outcome Expectation Scale | Week 0 | 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. |
| Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale | From Week 0, to week 24 or to week 52 | The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease. |
| Change in Arthritis Self-Efficacy Scale | From Week 0, to Week 12, or to week 24, or to week 52 | The Arthritis Self-Efficacy Scale is a self-report score measuring self-efficacy with respect to arthritis (range, 1 to 10, with higher scores indicating greater self-efficacy). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tai Chi 12 weeks of Tai Chi classes
Tai Chi: 12 weeks of Tai Chi | 106 |
| Physical Therapy 6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise | 98 |
| Total | 204 |
Baseline characteristics
| Characteristic | Tai Chi | Total | Physical Therapy |
|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 10.5 | 60.2 years STANDARD_DEVIATION 10.5 | 60.1 years STANDARD_DEVIATION 10.5 |
| Race/Ethnicity, Customized Asian | 4 participants | 6 participants | 2 participants |
| Race/Ethnicity, Customized Black | 41 participants | 72 participants | 31 participants |
| Race/Ethnicity, Customized Other | 7 participants | 18 participants | 11 participants |
| Race/Ethnicity, Customized White | 54 participants | 108 participants | 54 participants |
| Region of Enrollment United States | 106 participants | 204 participants | 98 participants |
| Sex: Female, Male Female | 75 Participants | 143 Participants | 68 Participants |
| Sex: Female, Male Male | 31 Participants | 61 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 106 | 0 / 98 |
| serious Total, serious adverse events | 0 / 106 | 0 / 98 |
Outcome results
Primary
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks
The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.
Time frame: From Week 0 to Week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tai Chi | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks | -167.2 units on a scale |
| Physical Therapy | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks | -143 units on a scale |
Secondary
Change in 20 Meter Walk Test
the 20-meter walk test is a performance measurement of walking ability (measured as the total number of seconds it takes to walk 20 meters); lower scores indicate improved walking ability
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in 20 Meter Walk Test | 12 weeks | -1.6 seconds |
| Tai Chi | Change in 20 Meter Walk Test | 24 weeks | -2.4 seconds |
| Tai Chi | Change in 20 Meter Walk Test | 52 weeks | -2.4 seconds |
| Physical Therapy | Change in 20 Meter Walk Test | 12 weeks | -1.1 seconds |
| Physical Therapy | Change in 20 Meter Walk Test | 24 weeks | -1.2 seconds |
| Physical Therapy | Change in 20 Meter Walk Test | 52 weeks | -1.0 seconds |
Secondary
Change in 6 Minute Walk
The 6 minute Walk Test is a measure of functional exercise capacity. Participants are asked to walk as far as possible within a six-minute period, and the distance covered at the end is noted and recorded.
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in 6 Minute Walk | Week 12 | 28.6 meters |
| Tai Chi | Change in 6 Minute Walk | Week 24 | 28.9 meters |
| Tai Chi | Change in 6 Minute Walk | Week 52 | 27.1 meters |
| Physical Therapy | Change in 6 Minute Walk | Week 12 | 26.1 meters |
| Physical Therapy | Change in 6 Minute Walk | Week 24 | 24.5 meters |
| Physical Therapy | Change in 6 Minute Walk | Week 52 | 22.8 meters |
Secondary
Change in Arthritis Self-Efficacy Scale
The Arthritis Self-Efficacy Scale is a self-report score measuring self-efficacy with respect to arthritis (range, 1 to 10, with higher scores indicating greater self-efficacy).
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Arthritis Self-Efficacy Scale | 52 weeks | 1.0 units on a scale |
| Tai Chi | Change in Arthritis Self-Efficacy Scale | 12 weeks | 1.3 units on a scale |
| Tai Chi | Change in Arthritis Self-Efficacy Scale | 24 weeks | 0.9 units on a scale |
| Physical Therapy | Change in Arthritis Self-Efficacy Scale | 12 weeks | 0.8 units on a scale |
| Physical Therapy | Change in Arthritis Self-Efficacy Scale | 24 weeks | 0.9 units on a scale |
| Physical Therapy | Change in Arthritis Self-Efficacy Scale | 52 weeks | 0.7 units on a scale |
Secondary
Change in Beck II Depression Inventory
Beck II Depression Inventory (BDI), second edition, is a 21-question, validated, self-report instrument that measures the severity of depressive symptoms. Total scores range from 0-63, and higher scores reflect greater depressive symptoms. BDI scores ranging from 0-13 represent minimal depressive symptoms; scores from 14-19 are mild; scores from 20-28 are moderate; and scores from 29-63 represent severe depressive symptoms.
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Beck II Depression Inventory | 12 weeks | -2.2 units on a scale |
| Tai Chi | Change in Beck II Depression Inventory | 24 weeks | -1.7 units on a scale |
| Tai Chi | Change in Beck II Depression Inventory | 52 weeks | -1.1 units on a scale |
| Physical Therapy | Change in Beck II Depression Inventory | 12 weeks | 0.5 units on a scale |
| Physical Therapy | Change in Beck II Depression Inventory | 24 weeks | 0.2 units on a scale |
| Physical Therapy | Change in Beck II Depression Inventory | 52 weeks | -0.003 units on a scale |
Secondary
Change in Medical Outcomes Short Form-36 PCS
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Medical Outcomes Short Form-36 PCS | week 12 | 6.3 units on a scale |
| Tai Chi | Change in Medical Outcomes Short Form-36 PCS | 24 weeks | 7.1 units on a scale |
| Tai Chi | Change in Medical Outcomes Short Form-36 PCS | 52 weeks | 6.3 units on a scale |
| Physical Therapy | Change in Medical Outcomes Short Form-36 PCS | week 12 | 3.1 units on a scale |
| Physical Therapy | Change in Medical Outcomes Short Form-36 PCS | 24 weeks | 3.4 units on a scale |
| Physical Therapy | Change in Medical Outcomes Short Form-36 PCS | 52 weeks | 4.3 units on a scale |
Secondary
Change in Patient Global VAS
Patients' global assessment score (Patient Global VAS) 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: From Week 0, to Week 12, or to week 24, or to week 52
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Patient Global VAS | 12 weeks | -0.3 units on a scale |
| Tai Chi | Change in Patient Global VAS | 24 weeks | -2.4 units on a scale |
| Tai Chi | Change in Patient Global VAS | 52 weeks | -1.84 units on a scale |
| Physical Therapy | Change in Patient Global VAS | 12 weeks | -0.2 units on a scale |
| Physical Therapy | Change in Patient Global VAS | 24 weeks | -1.73 units on a scale |
| Physical Therapy | Change in Patient Global VAS | 52 weeks | -1.31 units on a scale |
Secondary
Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS)
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component Score (MCS) is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS) | 12 weeks | 1.6 units on a scale |
| Tai Chi | Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS) | 24 weeks | 0.4 units on a scale |
| Tai Chi | Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS) | 52 weeks | -0.1 units on a scale |
| Physical Therapy | Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS) | 12 weeks | -0.03 units on a scale |
| Physical Therapy | Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS) | 24 weeks | -0.7 units on a scale |
| Physical Therapy | Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS) | 52 weeks | -1.5 units on a scale |
Secondary
Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale
The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.
Time frame: From Week 0, to week 24 or to week 52
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale | 24 weeks | -158.6 units on a scale |
| Tai Chi | Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale | 52 weeks | -138.8 units on a scale |
| Physical Therapy | Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale | 24 weeks | -124.3 units on a scale |
| Physical Therapy | Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale | 52 weeks | -121.0 units on a scale |
Secondary
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function
The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tai Chi | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function | 12 weeks | -608.3 units on a scale |
| Tai Chi | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function | 24 weeks | -586.8 units on a scale |
| Tai Chi | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function | 52 weeks | -532.3 units on a scale |
| Physical Therapy | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function | 12 weeks | -114.1 units on a scale |
| Physical Therapy | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function | 24 weeks | -455.7 units on a scale |
| Physical Therapy | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function | 52 weeks | -444.0 units on a scale |
Secondary
Outcome Expectation Scale
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.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi | Outcome Expectation Scale | 3.9 units on a scale | Standard Deviation 0.5 |
| Physical Therapy | Outcome Expectation Scale | 3.9 units on a scale | Standard Deviation 0.6 |