Knee OsteoarthritisNCT00362453
Tai Chi Mind-Body Therapy for Knee Osteoarthritis
A study of Knee Osteoarthritis, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Knee Osteoarthritis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts Medical Center, Division of Rheumatology
Boston, Massachusetts, 02111
About this study
Official title: Tai Chi Mind-Body Therapy for Knee Osteoarthritis: a Pilot Single-blind Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Tai Chi versus Attention Control
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi versus Attention ControlBehavioural
Also called Yang style Tai Chi
60 minutes, twice a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | The Tai Chi program was based on the classical Yang Style. Patients participated in 60-minute Tai Chi sessions twice a week for 12 weeks. Each session included warm up and review of Tai Chi principles and techniques; Tai Chi exercises; breathing techniques; and various relaxation methods. The classes were taught by a Tai Chi master with over 20 years' experience conducting Tai Chi Mind-Body exercise programs. Several modifications were developed to achieve the physical and mental goals of the study for knee OA, accommodate knee OA symptoms and limit dropouts. Subjects were instructed to practice Tai Chi at least 20 minutes a day at home and encouraged to maintain their usual physical activities, but not to participate in additional new strength training other than their Tai Chi exercises. Receives: Behavioral: Tai Chi versus Attention Control |
| Wellness Education and Stretching | Placebo comparator | The wellness education and stretching program provided an active control for the attention being paid to the Tai Chi group. The control group attended two 60-minute class sessions per week for 12 weeks. Each session started with 40 minutes of didactic lessons on OA knowledge, nutrition, and physical and mental health education. The final 20 minutes consisted of stretching exercises involving the upper body, trunk and lower body, each stretch being held for 10 to 15 seconds. Participants were also instructed to practice at least 20 minutes of stretching exercises per day at home. They were encouraged to maintain their usual physical activities, but not to participate in additional strength and mind-body exercise programs other than their stretching exercise. Receives: Behavioral: Tai Chi versus Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks
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.)
Measured: between baseline and 12 weeks.
Secondary outcomes (12)
Change in WOMAC Function From Baseline to 12, 24, and 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.)
Measured: from baseline to 12, 24, 48 weeks
Change in WOMAC Stiffness From Baseline to 12, 24, and 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.)
Measured: baseline to 12, 24, 48 weeks
Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks.
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.)
Measured: baseline to 24, 48 weeks
Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS)
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.)
Measured: baseline to 12, 24, 48 weeks
Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks.
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.)
Measured: baseline to 12, 24, 48 weeks
Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks.
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.)
Measured: baseline to 12, 24, 48 weeks
Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks.
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.
Measured: baseline to 12, 24, 48 weeks
Change in Standing Balance From Baseline to 12, 24, and 48 Weeks.
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.
Measured: baseline to 12, 24, 48 weeks
Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 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.)
Measured: baseline to 12, 24, 48 weeks
Change in Self-Efficacy Scale From Baseline to 12, 24, and 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.
Measured: baseline to 12, 24, 48 weeks
Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 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.
Measured: baseline, 12, 24, 48 weeks
Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component
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.
Measured: baseline to 12, 24, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startAug 2005
- Primary completionMar 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Chenchen Wang, MD, MSc, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362453
- Sponsor's protocol ID
- R21AT002161
- Other IDs
- R21AT002161
- Status last verified
- Apr 2019
- First submitted
- 9 Aug 2006
- Last updated
- 23 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 15006825Wang 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 15741197Wang 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 19877092Wang 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi Mind-Body Therapy for Knee Osteoarthritis: a Pilot Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00362453
- Acronym / sponsor ID
- R21AT002161
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Aug 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 10 Aug 2006 (estimated)
- Results
- Posted 8 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai Chi versus Attention ControlThe Tai Chi program was based on the classical Yang Style. Patients participated in 60-minute Tai Chi sessions twice a week for 12 weeks. Each session included warm up and review of Tai Chi principles and techniques; Tai Chi exercises; breathing techniques; and various relaxation methods. The classes were taught by a Tai Chi master with over 20 years' experience conducting Tai Chi Mind-Body exercise programs. Several modifications were developed to achieve the physical and mental goals of the study for knee OA, accommodate knee OA symptoms and limit dropouts. Subjects were instructed to practice Tai Chi at least 20 minutes a day at home and encouraged to maintain their usual physical activities, but not to participate in additional new strength training other than their Tai Chi exercises. |
| Wellness Education and Stretching | Placebo comparator | Behavioral: Tai Chi versus Attention ControlThe wellness education and stretching program provided an active control for the attention being paid to the Tai Chi group. The control group attended two 60-minute class sessions per week for 12 weeks. Each session started with 40 minutes of didactic lessons on OA knowledge, nutrition, and physical and mental health education. The final 20 minutes consisted of stretching exercises involving the upper body, trunk and lower body, each stretch being held for 10 to 15 seconds. Participants were also instructed to practice at least 20 minutes of stretching exercises per day at home. They were encouraged to maintain their usual physical activities, but not to participate in additional strength and mind-body exercise programs other than their stretching exercise. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi versus Attention ControlAlso: Yang style Tai Chi60 minutes, twice a week for 12 weeks. | Behavioural | Tai Chi, Wellness Education and Stretching |
Primary outcome
Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks
Time frame: between baseline and 12 weeks.
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.)
12 secondary outcomes
Change in WOMAC Function From Baseline to 12, 24, and 48 Weeks.
Time frame: from baseline to 12, 24, 48 weeks
Change in WOMAC Stiffness From Baseline to 12, 24, and 48 Weeks.
Time frame: baseline to 12, 24, 48 weeks
Change in WOMAC Pain Scores From Baseline to 24 and 48 Weeks.
Time frame: baseline to 24, 48 weeks
Change in Patient Global Knee Pain Assessment Visual Analogue Scale (VAS)
Time frame: baseline to 12, 24, 48 weeks
Change in Physician Global Knee Pain Assessment Visual Analogue Scale (VAS)From Baseline to 12, 24, and 48 Weeks.
Time frame: baseline to 12, 24, 48 weeks
Change in Timed Chair Stand From Baseline to 12, 24, and 48 Weeks.
Time frame: baseline to 12, 24, 48 weeks
Change in 6 Minute Walk Test From Baseline to 12, 24, and 48 Weeks.
Time frame: baseline to 12, 24, 48 weeks
Change in Standing Balance From Baseline to 12, 24, and 48 Weeks.
Time frame: baseline to 12, 24, 48 weeks
Change in Center for Epidemiology Studies Depression Index (CES-D)From Baseline to 12, 24, and 48 Weeks.
Time frame: baseline to 12, 24, 48 weeks
Change in Self-Efficacy Scale From Baseline to 12, 24, and 48 Weeks.
Time frame: baseline to 12, 24, 48 weeks
Change in Medical Outcome Study Short Form 36 (SF-36) Physical Component From Baseline to 12, 24, and 48 Weeks.
Time frame: baseline, 12, 24, 48 weeks
Change in Medical Outcome Study Short Form 36 (SF-36) Mental Component
Time frame: baseline to 12, 24, 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15006825Wang 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.
- Background: PubMed 15741197Wang 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.
- Derived from this study: PubMed 19877092Wang 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.
- Derived from this study: PubMed 18664276Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chenchen Wang, MD, MSc principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Knee Osteoarthritis, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Western Ontario and McMaster University Index (WOMAC) Pain Subscale Between Baseline and 12 Weeks (time frame: between baseline and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00362453, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.