Tai Chi and Physical Therapy for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— TCPT  

Official title:

Tai Chi and Physical Therapy for Knee Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01258985
• Other study ID #: 1R01AT005521-01A1
• Status: Active, not recruiting
• Phase: N/A
• First received: December 10, 2010
• Last updated: December 9, 2013
• Start date: March 2011
• Est. completion date: May 2014

Study information

• Verified date: December 2013
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Tai Chi
12 weeks of Tai Chi
• Physical Therapy
6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. doi: 10.1002/art.24832. — View Citation

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. doi: 10.1186/1471-2474-9-108. — View Citation

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. doi: 10.1056/NEJMoa0912611. — View Citation

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. doi: 10.1159/000134302. — View Citation

Outcome

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