Tai Chi and Physical Therapy for Knee Osteoarthritis (TCPT)

Tufts University

Status

Completed

Conditions

Knee Osteoarthritis

Treatments

Behavioral: Physical Therapy

Behavioral: Tai Chi

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01258985

UL1TR000073 (U.S. NIH Grant/Contract)

R01AT005521 (U.S. NIH Grant/Contract)

UL1TR001064 (U.S. NIH Grant/Contract)

1R01AT005521-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment

204 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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