Tai Chi and Physical Therapy for Knee Osteoarthritis
Status: | Completed |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 40 - Any |
Updated: | 11/30/2013 |
Start Date: | March 2011 |
End Date: | May 2014 |
Contact: | Fatima Shahzad, BA |
Email: | fshahzad@tuftsmedicalcenter.org |
Phone: | 617-636-9437 |
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.
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.
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
We found this trial at
1
site
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
Click here to add this to my saved trials