Clinical trial NCT00362453: Tai Chi Mind-Body Therapy for Knee Osteoarthritis
Official title: Tai Chi Mind-Body Therapy for Knee Osteoarthritis: a Pilot Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2006-08-10
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the safety and effectiveness of Tai Chi with an Attention Control intervention consisting of a stretching and wellness education program involving 40 patients with osteoarthritis (OA) of the knee. We hypothesized that the participants receiving Tai Chi would show greater improvement in knee pain, physical and psychological functioning, and health-related quality of life than participants in the Attention Control group, and that the benefit would be mediated by effects on muscle function, musculoskeletal flexibility and mental health.

Detailed description: Osteoarthritis (OA) is the most common form of arthritis in the United States, affecting 21 million older people. Symptomatic knee OA in the elderly is one of the most frequent causes of loss of independence and physical disability. There are currently no satisfactory pharmacological or non-pharmacological therapies for knee OA. New strategies to improve functional capacity, quality of life and reduce long-term disability in people with knee OA are urgently needed. Our long-term goal is to demonstrate the physical and psychological benefits of Tai Chi exercise as a complementary treatment for people with knee OA. Tai Chi is a traditional Chinese discipline with both physical and mental components that appear to benefit a variety of conditions. The physical component provides exercise that is consistent with recommendations for OA (range of motion, flexibility, muscle conditioning and aerobic cardiovascular exercise), while the mental component has the potential to increase psychological well-being, life satisfaction, and perceptions of health. These effects are especially pertinent for the treatment of older adults with knee OA.

Over a three-year period, 40 patients with symptomatic knee OA were randomly assigned to receive a 12-week Tai Chi program or stretching and wellness education program. Outcome measurements were obtained at baseline and on completion of the 12-week program, as well as 24 and 48 week follow-up periods. We compared changes in knee pain, stiffness, and physical function using the well-validated Western Ontario and McMaster Index (WOMAC), as well as clinical knee examination, lower extremity function, knee joint proprioception, and health related quality of life.

Eligibility criteria: Inclusion Criteria:

* Age 55 or older
* Body Mass Index (BMI) \<= 40 kg/m
* 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 in bed at night
* Radiographic evidence of knee OA, defined as the presence of osteophytes in the tibiofemoral compartment and/or the patellofemoral compartment, as assessed on standing anterior/posterior and lateral views
* WOMAC pain subscale score, at least 1 of 5 (range 0 to 100 each) \>= 40 (visual analog version)
* Physically able to participate in both the Tai Chi and stretching and education programs
* Willing to complete the 12-week study, including twice a week Tai Chi or stretching and education sessions
* Willing to abstain from Tai Chi until completion of the program, if randomized to the stretching and education sessions
* Willing to abstain from stretching and education sessions until completion of the program, if randomized to Tai Chi

Exclusion Criteria:

* Prior experience with Tai Chi or other similar types of Complementary and Alternative Medicine such as Qi gong, yoga, and acupuncture since these share some of the principles of Tai Chi
* Dementia, neurological disease, cardiovascular disease, pulmonary disease, metabolic disease, renal disease, liver disease, or other serious medical conditions limiting ability to participate in either the Tai Chi or stretching programs as determined by primary care physicians
* 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)
* Enrollment in any other clinical trial within the last 30 days
* Plan to permanently relocate from the region during the trial period
* Non English Speaking

Primary outcomes:
measure: Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks
timeFrame: between baseline and 12 weeks.
Secondary outcomes:
measure: Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks.
timeFrame: from baseline to 12, 24, 48 weeks
measure: Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks.
timeFrame: baseline to 12, 24, 48 weeks
measure: Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks.
timeFrame: baseline to 24, 48 weeks
measure: Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS)
timeFrame: baseline to 12, 24, 48 weeks
measure: Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks.
timeFrame: baseline to 12, 24, 48 weeks
measure: Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks.
timeFrame: baseline to 12, 24, 48 weeks
measure: Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks.
timeFrame: baseline to 12, 24, 48 weeks
measure: Change in Standing Balance From Baseline to 12, 24, and 48 Weeks.
timeFrame: baseline to 12, 24, 48 weeks
measure: Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks.
timeFrame: baseline to 12, 24, 48 weeks
measure: Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks.
timeFrame: baseline to 12, 24, 48 weeks
measure: Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks.
timeFrame: baseline, 12, 24, 48 weeks
measure: Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component
timeFrame: baseline to 12, 24, 48 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center, Division of Rheumatology
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Chenchen Wang, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1001/archinte.164.5.493.
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. doi: 10.1093/rheumatology/keh572. Epub 2005 Mar 1. No abstract available.
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.
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.