Trial Outcomes & Findings for Tai Chi Mind-Body Therapy for Knee Osteoarthritis (NCT NCT00362453)

NCT ID: NCT00362453

Last Updated: 2019-04-23

Results Overview

WOMAC scale range: 0 millimeters (no pain) to 500 millimeters (severe pain), ordinal. Change: score at 12 weeks minus score at baseline. Negative numbers reported here indicate improvement in condition from baseline. (So -100 indicates a 100-point improvement from baseline.)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: between baseline and 12 weeks.
• Results posted on: 2019-04-23

Participant Flow

During the 5-month recruitment period, we screened 366 patients from the Greater Boston area using telephone interviews. 62 potential patients visited the Clinical and Translational Research Center at Tufts Medical Center for further eligibility screening; 40 were eligible after baseline evaluation and randomized to Tai Chi or attention control.

We excluded individuals with: prior Tai Chi training or similar alternative medicine types like Qi Gong or yoga; serious medical conditions; intra-articular steroid injections in the last 3 months, reconstructive surgery on the affected knee, and intra-articular hyaluronate injections in the previous 6 months; failed the Mini-Mental examination.

Participant milestones

Measure	Tai Chi 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tai Chi Mind-Body Therapy for Knee Osteoarthritis

Baseline characteristics by cohort

Measure	Tai Chi n=20 Participants 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=20 Participants 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.	Total n=40 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 8.1 • n=93 Participants	68 years STANDARD_DEVIATION 7.0 • n=4 Participants	65 years STANDARD_DEVIATION 7.8 • n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	14 Participants n=4 Participants	30 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	6 Participants n=4 Participants	10 Participants n=27 Participants
Region of Enrollment United States	20 participants n=93 Participants	20 participants n=4 Participants	40 participants n=27 Participants

PRIMARY outcome

Timeframe: between baseline and 12 weeks.

Population: We analyzed the data on an intent-to-treat basis.

WOMAC scale range: 0 millimeters (no pain) to 500 millimeters (severe pain), ordinal. Change: score at 12 weeks minus score at baseline. Negative numbers reported here indicate improvement in condition from baseline. (So -100 indicates a 100-point improvement from baseline.)

Outcome measures

Measure	Tai Chi n=20 Participants 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=20 Participants 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks	-157.25 mm Interval -203.11 to -111.39	-38.45 mm Interval -84.31 to 7.41

SECONDARY outcome

Timeframe: from baseline to 12, 24, 48 weeks

The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The function subscale had a score range 0-1700mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -200 indicates a 200-point improvement from baseline.)

Outcome measures

Measure	Tai Chi n=20 Participants 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=20 Participants 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks. 12 Week	-506.75 mm Interval -640.66 to -372.84	-182.15 mm Interval -316.06 to -48.24
Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks. 24 Week	-440.50 mm Interval -574.41 to -306.59	-257.30 mm Interval -391.21 to -123.39
Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks. 48 Week	-405.85 mm Interval -539.76 to -271.94	-300.55 mm Interval -434.46 to -166.64

SECONDARY outcome

Timeframe: baseline to 12, 24, 48 weeks

The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The stiffness subscale has a score range 0-200mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -100 indicates a 100-point improvement from baseline.)

Outcome measures

Measure	Tai Chi n=20 Participants 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=20 Participants 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks. 12 Week	-73.05 mm Interval -94.36 to -51.74	-50.15 mm Interval -71.46 to -28.84
Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks. 24 Week	-65.00 mm Interval -86.31 to -43.69	-50.20 mm Interval -71.51 to -28.89
Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks. 48 Week	-64.15 mm Interval -85.46 to -42.84	-60.50 mm Interval -81.81 to -39.19

SECONDARY outcome

Timeframe: baseline to 24, 48 weeks

Population: The 12-Week WOMAC scores are listed under Primary Outcome. The 24-Week and 48-Week scores are listed as Secondary Outcomes.

The WOMAC is a validated, self-administered instrument specifically designed to evaluate knee and hip OA. The WOMAC was administered to the participants at baseline, 12, 24 and 48 weeks. The pain subscale score range was 0-500mm, with higher scores indicating more severe disease. Negative numbers reported here (change in subscale score) indicate improvement in condition from baseline. (So -200 indicates a 200-point improvement from baseline.)

Outcome measures

Measure	Tai Chi n=20 Participants 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=20 Participants 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks. 24 Weeks	-131.55 mm Interval -177.41 to -85.69	-64.60 mm Interval -110.46 to -18.74
Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks. 48 Weeks	-115.35 mm Interval -161.21 to -69.49	-69.20 mm Interval -115.06 to -23.34

SECONDARY outcome

Timeframe: baseline to 12, 24, 48 weeks

Participants completed a self-reported knee-specific global pain VAS with scores ranging from 0 to 10 centimeters (cm); 0 equals no pain. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-point improvement from baseline.)

Outcome measures

Measure	Tai Chi n=20 Participants 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=20 Participants 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS) 12 Week	-2.98 cm Interval -4.16 to -1.8	-0.83 cm Interval -2.0 to 0.35
Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS) 24 Week	-2.36 cm Interval -3.53 to -1.18	-1.71 cm Interval -2.89 to -0.53
Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS) 48 Week	-1.65 cm Interval -2.83 to -0.48	-1.70 cm Interval -2.87 to -0.52

SECONDARY outcome

Timeframe: baseline to 12, 24, 48 weeks

Population: Note: Data for only 19 participants in the Attention Control group was analyzed at 48 Weeks due to lack of available data.

The study physician who was blinded to group assignment completed a global knee pain assessment VAS with scores ranging from 0 to 10cm; 0 equals no pain. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-point improvement from baseline.)

Outcome measures

Measure	Tai Chi n=20 Participants 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=20 Participants 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks. 12 Week	-3.14 cm Interval -3.88 to -2.41	-1.44 cm Interval -2.18 to -0.7
Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks. 48 Week	-2.53 cm Interval -3.27 to -1.8	-1.50 cm Interval -2.25 to -0.75
Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks. 24 Week	-2.59 cm Interval -3.33 to -1.86	-2.06 cm Interval -2.8 to -1.32

SECONDARY outcome

Timeframe: baseline to 12, 24, 48 weeks

Population: Note: Data for only 18 participants in the Attention Control group was analyzed for the 48-week timepoint to do availability of data.

Timed stand tests measure the time taken to complete ten full stands from a sitting position. Patients began the chair stand seated with their arms folded across their chests, then rose to a standing position and sat back down with their back against the back rest of the chair. The test was completed when the patient stood for the tenth repetition. Chair stand time was measured in seconds, with lower scores indicating improved state. Negative numbers reported here indicate improvement in condition from baseline. (So -10 indicates a 10-second improvement from baseline.)

Outcome measures

Measure	Tai Chi n=19 Participants 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=19 Participants 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks. 12 Week	-12.03 seconds Interval -15.6 to -8.46	-1.15 seconds Interval -4.7 to 2.4
Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks. 24 Week	-9.87 seconds Interval -13.44 to -6.3	-4.75 seconds Interval -8.3 to -1.2
Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks. 48 Week	-9.22 seconds Interval -12.79 to -5.65	-3.24 seconds Interval -6.85 to 0.37

SECONDARY outcome

Timeframe: baseline to 12, 24, 48 weeks

Population: Note: Data for only 18 patients from Tai chi group was analyzed for 12 week timepoint. Data for 19 patients from the Attention Control group was analyzed at 48 week timepoint.

The 6 minute walk test is a reliable measure of functional exercise capacity. Patients were asked to walk as fast and as far as possible within the 6-minute period and were accompanied by the research staff using a wheel measure that measured distance covered in inches and convereted to yards; higher scores indicated improved state. Higher numbers reported here indicate more improvement from baseline.

Outcome measures

Measure	Tai Chi n=19 Participants 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=20 Participants 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks. 12 Week	48.33 yards Interval 11.15 to 85.5	-1.76 yards Interval -50.7 to 47.18
Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks. 24 Week	53.12 yards Interval 10.04 to 96.21	9.41 yards Interval -33.48 to 52.3
Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks. 48 Week	35.17 yards Interval -17.29 to 87.64	20.56 yards Interval -20.73 to 61.85

SECONDARY outcome

Timeframe: baseline to 12, 24, 48 weeks

Population: Note: Data for only 19 patients in Attention Control group was analyzed for 48-week timepoint due to availability of data.

The standing balance test included tandem, semi-tandem, side-by-side, and one-legged stands. Patients were asked to maintain each position for 30 seconds. For each task, the research staff first demonstrated the task, asked the patient if they felt comfortable and ready and then supported the patient while positioning themselves. One point was given if they exceeded 30 seconds and none if they could not or did not attempt the test. Higher numbers reported here indicate more improvement from baseline.

Outcome measures

Measure	Tai Chi n=20 Participants 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=20 Participants 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Change in Standing Balance From Baseline to 12, 24, and 48 Weeks. 24 Weeks	0.15 units on a scale Interval -0.16 to 0.46	0.08 units on a scale Interval -0.24 to 0.39
Change in Standing Balance From Baseline to 12, 24, and 48 Weeks. 48 Weeks	0.35 units on a scale Interval 0.04 to 0.66	0.46 units on a scale Interval 0.14 to 0.77
Change in Standing Balance From Baseline to 12, 24, and 48 Weeks. 12 Weeks	0.15 units on a scale Interval -0.16 to 0.46	0.25 units on a scale Interval -0.06 to 0.56

SECONDARY outcome

Timeframe: baseline to 12, 24, 48 weeks

The CES-D was used to assess depressive symptoms. It included a 20-item Likert-type scale with scores ranging from 0 to 60. Higher scores indicated greater dysphoria. Negative numbers reported here indicate improvement in condition from baseline. (So -1 indicates a 1-point improvement from baseline.)

Outcome measures

Measure	Tai Chi n=20 Participants 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=20 Participants 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks. 12 Week	-7.40 units on a scale Interval -10.88 to -3.92	-0.70 units on a scale Interval -4.18 to 2.78
Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks. 24 Week	-6.40 units on a scale Interval -9.88 to -2.92	-1.10 units on a scale Interval -4.58 to 2.38
Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks. 48 Week	-7.25 units on a scale Interval -10.73 to -3.77	1.65 units on a scale Interval -1.83 to 5.13

SECONDARY outcome

Timeframe: baseline to 12, 24, 48 weeks

Self-efficacy is important for individuals to adopt and maintain a program of regular physical activity. The patient rates his/her confidence of being physically active in different types of situations on a 5-item scale with responses ranging from "not at all confident" to "extremely confident". The total score is coputed by calculating the average of all 5 questions. A higher score indicates greater self-efficacy. Higher numbers reported here indicate more improvement from baseline.

Outcome measures

Measure	Tai Chi n=20 Participants 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=20 Participants 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks. 12 Week	0.60 units on a scale Interval 0.12 to 1.08	-0.11 units on a scale Interval -0.59 to 0.37
Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks. 24 Week	0.68 units on a scale Interval 0.2 to 1.16	-0.17 units on a scale Interval -0.65 to 0.31
Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks. 48 Week	0.72 units on a scale Interval 0.24 to 1.2	-0.24 units on a scale Interval -0.72 to 0.24

SECONDARY outcome

Timeframe: baseline, 12, 24, 48 weeks

Health related quality of life assessments were made using the SF-36. The SF-36 measures 8 domains: physical functioning, role-physician, bodily pain, general health, vitality, social function, emotional health and mental health. The Physical Component of the SF-36 had scores that ranged from 0 to 100; 0 equals worst health state. Change: Higher numbers reported here indicate more improvement in condition from baseline.

Outcome measures

Measure	Tai Chi n=20 Participants 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=20 Participants 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks. 12 Weeks	11.57 units on a scale Interval 8.08 to 15.06	4.14 units on a scale Interval 0.65 to 7.63
Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks. 24 Weeks	10.80 units on a scale Interval 7.31 to 14.29	6.29 units on a scale Interval 2.8 to 9.77
Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks. 48 Weeks	10.41 units on a scale Interval 6.92 to 13.9	4.10 units on a scale Interval 0.61 to 7.58

SECONDARY outcome

Timeframe: baseline to 12, 24, 48 weeks

Health related quality of life assessments were made using the SF-36. The SF-36 measures 8 domains: physical functioning, role-physician, bodily pain, general health, vitality, social function, emotional health and mental health. The Mental Component of the SF-36 had scores that ranged from 0 to 100; 0 equals worst health state. Change: Higher numbers reported here indicate more improvement in condition from baseline.

Outcome measures

Measure	Tai Chi n=20 Participants 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=20 Participants 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component 12 Weeks	2.14 units on a scale Interval -2.35 to 6.64	1.93 units on a scale Interval -2.56 to 6.43
Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component 24 Weeks	4.39 units on a scale Interval -0.11 to 8.89	4.50 units on a scale Interval 0.0 to 9.0
Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component 48 Weeks	5.80 units on a scale Interval 1.31 to 10.3	1.04 units on a scale Interval -3.46 to 5.53

Adverse Events

Tai Chi

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Attention Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tai Chi n=20 participants at risk 20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.	Attention Control n=20 participants at risk 20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
Musculoskeletal and connective tissue disorders increased knee pain	5.0% 1/20 • Number of events 1 • during 12 week intervention period One participant in the Tai Chi group reported an increase in knee pain at the 2 week assessment. This was resolved following modification of that participant's Tai Chi technique.	0.00% 0/20 • during 12 week intervention period One participant in the Tai Chi group reported an increase in knee pain at the 2 week assessment. This was resolved following modification of that participant's Tai Chi technique.

Additional Information

Chenchen Wang, MD, MSc, Associate Professor

Tufts Medical Center

Phone: 617-636-3251

Email: cwang2@tuftsmedicalcenter.org

Results disclosure agreements

• Principal investigator is a sponsor employee The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of the National Center for Complementary and Alternative Medicine or the National Institutes of Health. The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review or approval of the manuscript.
• Publication restrictions are in place

Restriction type: OTHER