Tai Chi and Physical Therapy for Knee Osteoarthritis - Full Text View

Purpose

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.

Condition	Intervention
Knee Osteoarthritis	Behavioral: Tai Chi Behavioral: Physical Therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Tai Chi and Physical Therapy for Knee Osteoarthritis

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Osteoarthritis

U.S. FDA Resources

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:

Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale from baseline to 12 Weeks [ Time Frame: Week 0, Week 12 ] [ Designated as safety issue: No ]
Pain

Secondary Outcome Measures:

Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale at follow-up [ Time Frame: Week 0, Week 24, Week 52 ] [ Designated as safety issue: No ]
Body Mass Index [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Medical Outcomes Short Form-36 [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Quality of Life
PROMIS Physical Functioning Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
physical function
6 Minute Walk [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Walking ability and endurance
20 Meter Walk [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
walking ability
Chair Stand Test [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Lower extremity physical function
Berg Balance Scale [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Balance
Qualitative Gait Analysis [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Video-taped gait analysis
Postural Sway [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Balance and postural sway
Muscle Strength and Leg Power [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
muscle strength and power
Beck II Depression Inventory [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Depression
Perceived Stress Scale [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Stress
PROMIS Pain Impact Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Pain
PROMIS Distress-Depression Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Depression
PROMIS Distress-Anxiety Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Anxiety
PROMIS Sleep Disturbance Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Sleep quality
PROMIS Social Roles Short Form [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Social Roles and Satisfaction
Arthritis Self-Efficacy Scale function subscale [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Self-efficacy
Medical Outcome Study Social Support Survey [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Social Support
Western Ontario and McMaster Universities Arthritis Index (WOMAC) physical function and stiffness [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
physical function and stiffness
PROMIS Health Assessment Questionnaire [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Health Status
Health Assessment Questionnaire Utilization [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Healthcare cost and utilization
Outcome Expectation Scale [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Participant expectations
Champs Activity Questionnaire for Older Adults [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
Physical Activity Levels

Estimated Enrollment:	180
Study Start Date:	March 2011
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Tai Chi 12 weeks of Tai Chi classes	Behavioral: Tai Chi 12 weeks of Tai Chi
Active Comparator: Physical Therapy 6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise	Behavioral: Physical Therapy 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258985

Contacts

Contact: Fatima Shahzad, BA	617-636-9437	fshahzad@tuftsmedicalcenter.org
Contact: Chenchen Wang, MD, MSc	617-636-3251	cwang2@tuftsmedicalcenter.org

Locations

United States, Massachusetts
Tufts Medical Center	Recruiting
Boston, Massachusetts, United States, 02111
Contact: Marcie Griffith, MAOM 617-636-2612 TCPT@tuftsmedicalcenter.org

Sponsors and Collaborators

Tufts Medical Center

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Chenchen Wang, MD, MSc

Tufts Medical Center

More Information

Publications:

Wang C, Collet JP, Lau J. The effect of Tai Chi on health outcomes in patients with chronic conditions: a systematic review. Arch Intern Med. 2004 Mar 8;164(5):493-501. Review.

Wang C, Roubenoff R, Lau J, Kalish R, Schmid CH, Tighiouart H, Rones R, Hibberd PL. Effect of Tai Chi in adults with rheumatoid arthritis. Rheumatology (Oxford). 2005 May;44(5):685-7. Epub 2005 Mar 1. No abstract available.

Wang C. Tai Chi improves pain and functional status in adults with rheumatoid arthritis: results of a pilot single-blinded randomized controlled trial. Med Sport Sci. 2008;52:218-29.

Wang C, Schmid CH, Rones R, Kalish R, Yinh J, Goldenberg DL, Lee Y, McAlindon T. A randomized trial of tai chi for fibromyalgia. N Engl J Med. 2010 Aug 19;363(8):743-54.

Wang C, Schmid CH, Hibberd PL, Kalish R, Roubenoff R, Rones R, McAlindon T. Tai Chi is effective in treating knee osteoarthritis: a randomized controlled trial. Arthritis Rheum. 2009 Nov 15;61(11):1545-53.

Wang C, Schmid CH, Hibberd PL, Kalish R, Roubenoff R, Rones R, Okparavero A, McAlindon T. Tai Chi for treating knee osteoarthritis: designing a long-term follow up randomized controlled trial. BMC Musculoskelet Disord. 2008 Jul 29;9:108.

Responsible Party:	Tufts Medical Center
ClinicalTrials.gov Identifier:	NCT01258985 History of Changes
Other Study ID Numbers:	1R01AT005521-01A1
Study First Received:	December 10, 2010
Last Updated:	May 30, 2012
Health Authority:	United States: Federal Government United States: Institutional Review Board

Keywords provided by Tufts Medical Center:

Knee
Knee osteoarthritis
osteoarthritis
Knee pain

Tai Chi
Physical Therapy
mind-body exercise

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013

Tai Chi and Physical Therapy for Knee Osteoarthritis (TCPT)