Status:
COMPLETED
Tai Chi and Physical Therapy for Knee Osteoarthritis
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
NA
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 nonst...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT01258985
Start Date
March 1 2011
End Date
September 1 2014
Last Update
August 4 2016
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111