Tai Chi and Physical Therapy for Knee Osteoarthritis

Not Applicable

Completed

Conditions: Knee Osteoarthritis

Interventions: Behavioral: Tai Chi
Behavioral: Physical Therapy

Registration Number: NCT01258985

Lead Sponsor: Tufts Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 204

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tai Chi	Tai Chi	12 weeks of Tai Chi classes
Physical Therapy	Physical Therapy	6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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).
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.