CompletedNCT01258985TCPTUpdated Aug 4, 2016Results posted

Tai Chi and Physical Therapy for Knee Osteoarthritis

An interventional study of Tai Chi and Physical Therapy in Knee Osteoarthritis, sponsored by Tufts Medical Center. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-08-04.

Sponsored by Tufts Medical Center · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 204
Allocation: Randomized
Ages: 40 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Knee Osteoarthritis

Browse trials for

Keywords

Knee
Knee osteoarthritis
osteoarthritis
Knee pain
Tai Chi
Physical Therapy
mind-body exercise

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 204 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Tufts Medical Center is the lead sponsor of 194 studies on the registry; 28 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 16 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 204 participants (actual)

Study arms

Active comparator
Tai Chi
12 weeks of Tai Chi classes
Behavioral: Tai Chi
Active comparator
Physical Therapy
6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise
Behavioral: Physical Therapy

Interventions

BehavioralTai Chi
12 weeks of Tai Chi
BehavioralPhysical Therapy
6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise

What researchers measure

Primary outcomes

Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks
The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.
Time frame: From Week 0 to Week 12

Secondary outcomes

Change in Medical Outcomes Short Form-36 PCS
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
Change in 6 Minute Walk
The 6 minute Walk Test is a measure of functional exercise capacity. Participants are asked to walk as far as possible within a six-minute period, and the distance covered at the end is noted and recorded.
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
Change in 20 Meter Walk Test
the 20-meter walk test is a performance measurement of walking ability (measured as the total number of seconds it takes to walk 20 meters); lower scores indicate improved walking ability
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
Change in Patient Global VAS
Patients' global assessment score (Patient Global VAS) was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
Change in Beck II Depression Inventory
Beck II Depression Inventory (BDI), second edition, is a 21-question, validated, self-report instrument that measures the severity of depressive symptoms. Total scores range from 0-63, and higher scores reflect greater depressive symptoms. BDI scores ranging from 0-13 represent minimal depressive symptoms; scores from 14-19 are mild; scores from 20-28 are moderate; and scores from 29-63 represent severe depressive symptoms.
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
Change in Arthritis Self-Efficacy Scale
The Arthritis Self-Efficacy Scale is a self-report score measuring self-efficacy with respect to arthritis (range, 1 to 10, with higher scores indicating greater self-efficacy).
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS)
The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component Score (MCS) is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function
The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.
Time frame: From Week 0, to Week 12, or to week 24, or to week 52
Outcome Expectation Scale
The Outcome Expectations for Exercise Scale (range, 1 to 5, with 1 indicating no expectations for exercise and 5 the highest expectations for exercise) is a self-report measure of outcome expectations for exercise.
Time frame: Week 0
Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale
The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.
Time frame: From Week 0, to week 24 or to week 52

Results

Posted Aug 4, 2016

Participant flow

Participant flow — Overall Study
Milestone	Tai Chi	Physical Therapy
Started	106	98
Completed	106	98
Not completed	0	0

Outcome measures

PrimaryChange in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks

The WOMAC (version: Visual Analog Scale 3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.

Time frame:: From Week 0 to Week 12
Reported as:: Mean · units on a scale

Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks
units on a scale	Tai Chi	Physical Therapy
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)Pain Subscale From Baseline to 12 Weeks	-167.2 (-190.4 to -144.9)	-143 (-167.4 to -118.6)

SecondaryChange in Medical Outcomes Short Form-36 PCS

The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) is the summary score for the physical quality-of-life components (range, 0 to 100, with higher scores indicating better health status)

Time frame:: From Week 0, to Week 12, or to week 24, or to week 52
Reported as:: Mean · units on a scale

Change in Medical Outcomes Short Form-36 PCS
units on a scale	Tai Chi	Physical Therapy
week 12	6.3 (4.6 to 7.9)	3.1 (1.4 to 4.8)
24 weeks	7.1 (5.1 to 9.0)	3.4 (1.4 to 5.5)
52 weeks	6.3 (4.4 to 8.3)	4.3 (2.3 to 6.4)

SecondaryChange in 6 Minute Walk

The 6 minute Walk Test is a measure of functional exercise capacity. Participants are asked to walk as far as possible within a six-minute period, and the distance covered at the end is noted and recorded.

Time frame:: From Week 0, to Week 12, or to week 24, or to week 52
Reported as:: Mean · meters

Change in 6 Minute Walk
meters	Tai Chi	Physical Therapy
Week 12	28.6 (17.9 to 39.2)	26.1 (14.9 to 37.4)
Week 24	28.9 (16.6 to 41.2)	24.5 (11.5 to 37.5)
Week 52	27.1 (12.2 to 42.0)	22.8 (7.0 to 38.6)

SecondaryChange in 20 Meter Walk Test

the 20-meter walk test is a performance measurement of walking ability (measured as the total number of seconds it takes to walk 20 meters); lower scores indicate improved walking ability

Time frame:: From Week 0, to Week 12, or to week 24, or to week 52
Reported as:: Mean · seconds

Change in 20 Meter Walk Test
seconds	Tai Chi	Physical Therapy
12 weeks	-1.6 (-2.4 to -0.8)	-1.1 (-2.0 to -0.2)
24 weeks	-2.4 (-3.4 to -1.3)	-1.2 (-2.2 to -0.1)
52 weeks	-2.4 (-3.5 to -1.4)	-1.0 (-2.1 to 0.2)

SecondaryChange in Patient Global VAS

Patients' global assessment score (Patient Global VAS) was assessed separately by the participant, who was unaware of the group assignment, with the use of a visual-analogue scale (VAS) (range, 0 to 10,with higher scores indicating greater pain).

Time frame:: From Week 0, to Week 12, or to week 24, or to week 52
Reported as:: Mean · units on a scale

Change in Patient Global VAS
units on a scale	Tai Chi	Physical Therapy
12 weeks	-0.3 (-0.3 to -0.2)	-0.2 (-0.3 to -0.2)
24 weeks	-2.4 (-2.93 to -1.88)	-1.73 (-2.29 to -1.17)
52 weeks	-1.84 (-2.48 to -1.21)	-1.31 (-1.96 to -0.66)

SecondaryChange in Beck II Depression Inventory

Beck II Depression Inventory (BDI), second edition, is a 21-question, validated, self-report instrument that measures the severity of depressive symptoms. Total scores range from 0-63, and higher scores reflect greater depressive symptoms. BDI scores ranging from 0-13 represent minimal depressive symptoms; scores from 14-19 are mild; scores from 20-28 are moderate; and scores from 29-63 represent severe depressive symptoms.

Time frame:: From Week 0, to Week 12, or to week 24, or to week 52
Reported as:: Mean · units on a scale

Change in Beck II Depression Inventory
units on a scale	Tai Chi	Physical Therapy
12 weeks	-2.2 (-3.7 to -0.9)	0.5 (-1 to 2)
24 weeks	-1.7 (-3.1 to -0.4)	0.2 (-1.3 to 1.7)
52 weeks	-1.1 (-2.7 to 0.5)	-0.003 (-1.6 to 1.6)

SecondaryChange in Arthritis Self-Efficacy Scale

The Arthritis Self-Efficacy Scale is a self-report score measuring self-efficacy with respect to arthritis (range, 1 to 10, with higher scores indicating greater self-efficacy).

Time frame:: From Week 0, to Week 12, or to week 24, or to week 52
Reported as:: Mean · units on a scale

Change in Arthritis Self-Efficacy Scale
units on a scale	Tai Chi	Physical Therapy
12 weeks	1.3 (0.8 to 1.8)	0.8 (0.3 to 1.4)
24 weeks	0.9 (0.4 to 1.4)	0.9 (0.4 to 1.4)
52 weeks	1.0 (0.5 to 1.5)	0.7 (0.2 to 1.2)

SecondaryChange in Short-Form Health Survey (SF-36) Mental Component Score (MCS)

The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Mental Component Score (MCS) is the summary score for the mental quality-of-life components (range, 0 to 100, with higher scores indicating better health status)

Time frame:: From Week 0, to Week 12, or to week 24, or to week 52
Reported as:: Mean · units on a scale

Change in Short-Form Health Survey (SF-36) Mental Component Score (MCS)
units on a scale	Tai Chi	Physical Therapy
12 weeks	1.6 (-0.1 to 3.2)	-0.03 (-1.7 to 1.7)
24 weeks	0.4 (-1.5 to 2.2)	-0.7 (-2.7 to 1.4)
52 weeks	-0.1 (-1.9 to 1.8)	-1.5 (-3.4 to 0.4)

SecondaryChange in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function

The WOMAC (version VA3.1) is a validated, self-administered, visual analogue scale specifically designed to evaluate knee and hip osteoarthritis. It has three subscales that are analyzed separately: pain (score range, 0-500), stiffness (0-200), and function (0-1700), with higher scores indicating more severe disease.

Time frame:: From Week 0, to Week 12, or to week 24, or to week 52
Reported as:: Mean · units on a scale

Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Physical Function
units on a scale	Tai Chi	Physical Therapy
12 weeks	-608.3 (-695.3 to -521.4)	-114.1 (-240 to 118)
24 weeks	-586.8 (-669.5 to -504.1)	-455.7 (-543.1 to -368.4)
52 weeks	-532.3 (-625.9 to -438.7)	-444.0 (-541.3 to -346.7)

SecondaryOutcome Expectation Scale

The Outcome Expectations for Exercise Scale (range, 1 to 5, with 1 indicating no expectations for exercise and 5 the highest expectations for exercise) is a self-report measure of outcome expectations for exercise.

Time frame:: Week 0
Reported as:: Mean · units on a scale

Outcome Expectation Scale
units on a scale	Tai Chi	Physical Therapy
Outcome Expectation Scale	3.9 ± 0.5	3.9 ± 0.6

SecondaryChange in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale

Time frame:: From Week 0, to week 24 or to week 52
Reported as:: Mean · units on a scale

Change in Western Ontario and McMasters University Osteoarthritis Index (WOMAC) Pain Subscale
units on a scale	Tai Chi	Physical Therapy
24 weeks	-158.6 (-182.9 to -134.3)	-124.3 (-150.0 to -98.5)
52 weeks	-138.8 (-166.7 to -110.8)	-121.0 (-150.0 to -91.9)

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Tai Chi	—	0/106 (0%)	0/106 (0%)
Physical Therapy	—	0/98 (0%)	0/98 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Tai Chi	Physical Therapy	Total
Mean	60.3 ± 10.5	60.1 ± 10.5	60.2 ± 10.5

Sex: Female, Male
Sex: Female, Male(Participants)	Tai Chi	Physical Therapy	Total
Female	75	68	143
Male	31	30	61

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Tai Chi	Physical Therapy	Total
White	54	54	108
Black	41	31	72
Asian	4	2	6
Other	7	11	18

Region of Enrollment
Region of Enrollment(participants)	Tai Chi	Physical Therapy	Total
United States	106	98	204

Study locations

1 site

Tufts Medical Center
Boston, Massachusetts 02111, United States

References and documents

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. doi: 10.1001/archinte.164.5.493. PubMed 15006825 ↗
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. PubMed 15741197 ↗
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;52:218-229. doi: 10.1159/000134302. PubMed 18487901 ↗
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. PubMed 20818876 ↗
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. PubMed 19877092 ↗
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. PubMed 18664276 ↗
Reid KF, Price LL, Harvey WF, Driban JB, Hau C, Fielding RA, Wang C. Muscle Power Is an Independent Determinant of Pain and Quality of Life in Knee Osteoarthritis. Arthritis Rheumatol. 2015 Dec;67(12):3166-73. doi: 10.1002/art.39336. PubMed 26315282 ↗
Lee AC, Harvey WF, Price LL, Han X, Driban JB, Iversen MD, Desai SA, Knopp HE, Wang C. Dose-Response Effects of Tai Chi and Physical Therapy Exercise Interventions in Symptomatic Knee Osteoarthritis. PM R. 2018 Jul;10(7):712-723. doi: 10.1016/j.pmrj.2018.01.003. Epub 2018 Jan 31. PubMed 29407226 ↗
Lee AC, Harvey WF, Price LL, Han X, Driban JB, Wong JB, Chung M, McAlindon TE, Wang C. Mindfulness Is Associated With Treatment Response From Nonpharmacologic Exercise Interventions in Knee Osteoarthritis. Arch Phys Med Rehabil. 2017 Nov;98(11):2265-2273.e1. doi: 10.1016/j.apmr.2017.04.014. Epub 2017 May 12. PubMed 28506776 ↗
Lee AC, Driban JB, Price LL, Harvey WF, Rodday AM, Wang C. Responsiveness and Minimally Important Differences for 4 Patient-Reported Outcomes Measurement Information System Short Forms: Physical Function, Pain Interference, Depression, and Anxiety in Knee Osteoarthritis. J Pain. 2017 Sep;18(9):1096-1110. doi: 10.1016/j.jpain.2017.05.001. Epub 2017 May 10. PubMed 28501708 ↗
Wang C, Schmid CH, Iversen MD, Harvey WF, Fielding RA, Driban JB, Price LL, Wong JB, Reid KF, Rones R, McAlindon T. Comparative Effectiveness of Tai Chi Versus Physical Therapy for Knee Osteoarthritis: A Randomized Trial. Ann Intern Med. 2016 Jul 19;165(2):77-86. doi: 10.7326/M15-2143. Epub 2016 May 17. PubMed 27183035 ↗
Driban JB, Morgan N, Price LL, Cook KF, Wang C. Patient-Reported Outcomes Measurement Information System (PROMIS) instruments among individuals with symptomatic knee osteoarthritis: a cross-sectional study of floor/ceiling effects and construct validity. BMC Musculoskelet Disord. 2015 Sep 14;16:253. doi: 10.1186/s12891-015-0715-y. PubMed 26369412 ↗
Wang C, Iversen MD, McAlindon T, Harvey WF, Wong JB, Fielding RA, Driban JB, Price LL, Rones R, Gamache T, Schmid CH. Assessing the comparative effectiveness of Tai Chi versus physical therapy for knee osteoarthritis: design and rationale for a randomized trial. BMC Complement Altern Med. 2014 Sep 8;14:333. doi: 10.1186/1472-6882-14-333. PubMed 25199526 ↗

Individual participant data

Plan to share: Yes — De-identified participant data will be made available upon request.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01258985
Lead sponsor: Tufts Medical Center
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Responsible party: Sponsor
First posted: Dec 13, 2010
Start date: Mar 2011
Primary completion: Sep 2014
Completion: Sep 2014
Results posted: Aug 4, 2016
Last update: Aug 4, 2016

Study contacts

Chenchen Wang, MD, MSc

principal investigator · Tufts Medical Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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