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| ID | Type | Description | Link |
|---|---|---|---|
| UH3AT012413 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Boston Medical Center | OTHER |
| University of California, Los Angeles | OTHER |
| The Cleveland Clinic | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) |
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The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are:
Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain. Participants will participate in remotely delivered web-based tai chi sessions, twice a week for 12 weeks, or will continue to receive routine care. Participants will be followed for 12 months after randomization.
Investigators will conduct a 12-month embedded, pragmatic, hybrid type 1 effectiveness-implementation, individually randomized group-treatment trial that will compare the effects of a 3-month twice weekly remotely delivered web-based Tai Chi intervention plus routine care versus routine care alone across four health care systems (Tufts Medical Center, Boston Medical Center, University of California Los Angeles Health, and Cleveland Clinic) in four geographic regions (Eastern Massachusetts, Southern California, Northeast Ohio (Cleveland Clinic), Southern Florida (Cleveland Clinic). Investigators will enroll a total of 480 diverse patients with a clinical diagnosis of Knee OA. Participants will be evaluated at baseline and 3 months, with additional follow-up at 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tai Chi + Routine Care | Experimental | The intervention will be delivered via a HIPAA-secure web-based video platform. All remote Tai Chi sessions will be 60 minutes, twice a week, for 3 months. All program components will use the Yang style Tai Chi, and every session will include warm up, review of principles, meditation with movement, breathing techniques and relaxation. |
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| Routine Care | No Intervention | Participants will be encouraged to continue their ongoing care for Knee OA by their providers. In addition, primary care providers and other participating clinicians in the health system will receive information from the study team on routine care or "2019 ACR Guideline-Based Care." At the end of the 12-month trial period, routine care participants will be offered access to recordings for the full 3-month Tai Chi program (24 sessions). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Tai Chi | Other | Tai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements. |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Pain Score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm. | 3 months from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Pain Interference score | The PROMIS Pain Interference short form 6b evaluates the extent to which pain interferes with physical, emotional and social activities. The raw score ranges between 6-30 and the T score ranges between 41.0-78.3, with higher scores indicating that pain has a greater negative impact. | 3 months from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC Pain Score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm. | 6 months from randomization |
| WOMAC Pain Score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chenchen Wang, MD, MSc | Contact | 617-636-3251 | Chenchen.Wang@tuftsmedicine.org | |
| Sherwood Alexis, MHA, MBA | Contact | 617-636-5405 | sherwood.alexis@tuftsmedicalcenter.org |
| Name | Affiliation | Role |
|---|---|---|
| Chenchen Wang, MD, MSc | Tufts Medical Center | Principal Investigator |
| Robert Saper, MD, MPH | The Cleveland Clinic | Principal Investigator |
| Eric Roseen, DC, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111 | United States |
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| Label | URL |
|---|---|
| Study website | View source |
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This study will submit and share de-identified individual patient data as described in our Data Management and Sharing Plan and will follow NIH policies for data sharing
The time of results publication or the end of the funding period.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| NIH |
The study is an individually randomized group-treatment (IRGT) trial. Individuals randomly allocated to remote Tai Chi receive the intervention with other participants through an instructor.
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| SF-12 PCS score | The 12-item Short Form Health Survey (SF-12) has two summary scales, the Mental Health Component Score (MCS) and the Physical Component Score (PCS). Both scores range from 0 to 100, with higher scores indicating better mental and physical health. | 3 months from randomization |
| Number of knee joint injections | Total number of intra-articular injections identified through EHR and patient questionnaires. | 12 months from randomization |
| 12 months from randomization |
| PROMIS Pain Interference score | The PROMIS Pain Interference short form 6b evaluates the extent to which pain interferes with physical, emotional and social activities. The raw score ranges between 6-30 and the T score ranges between 41.0-78.3, with higher scores indicating that pain has a greater negative impact. | 6 months from randomization |
| PROMIS Pain Interference score | The PROMIS Pain Interference short form 6b evaluates the extent to which pain interferes with physical, emotional and social activities. The raw score ranges between 6-30 and the T score ranges between 41.0-78.3, with higher scores indicating that pain has a greater negative impact. | 12 months from randomization |
| SF-12 PCS score | The 12-item Short Form Health Survey (SF-12) has two summary scales, the Mental Health Component Score (MCS) and the Physical Component Score (PCS). Both scores range from 0 to 100, with higher scores indicating better mental and physical health. | 6 months from randomization |
| SF-12 PCS score | The 12-item Short Form Health Survey (SF-12) has two summary scales, the Mental Health Component Score (MCS) and the Physical Component Score (PCS). Both scores range from 0 to 100, with higher scores indicating better mental and physical health. | 12 months from randomization |
| WOMAC total score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score calculated by summing the pain, stiffness, and physical function subscales, rated on a Visual Analog Scale (VAS) of 0-100 mm. | 3 months from randomization |
| WOMAC total score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score calculated by summing the pain, stiffness, and physical function subscales, rated on a Visual Analog Scale (VAS) of 0-100 mm. | 6 months from randomization |
| WOMAC total score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score calculated by summing the pain, stiffness, and physical function subscales, rated on a Visual Analog Scale (VAS) of 0-100 mm. | 12 months from randomization |
| WOMAC Pain Score on nominated activity chosen at baseline | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.(Considering ALL the ways Knee PAIN affects participants, which activity is most important to participants today?) | 3 months from randomization |
| WOMAC Pain Score on nominated activity chosen at baseline | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.(Considering ALL the ways Knee PAIN affects participants, which activity is most important to participants today?) | 6 months from randomization |
| WOMAC Pain Score on nominated activity chosen at baseline | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.(Considering ALL the ways Knee PAIN affects participants, which activity is most important to participants today?) | 12 months from randomization |
| WOMAC function score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score rated on a Visual Analog Scale (VAS) of 0-100 mm. | 3 months from randomization |
| WOMAC function score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score rated on a Visual Analog Scale (VAS) of 0-100 mm. | 6 months from randomization |
| WOMAC function score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score rated on a Visual Analog Scale (VAS) of 0-100 mm. | 12 months from randomization |
| WOMAC stiffness score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness score rated on a Visual Analog Scale (VAS) of 0-100 mm. | 3 months from randomization |
| WOMAC stiffness score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness score rated on a Visual Analog Scale (VAS) of 0-100 mm. | 6 months from randomization |
| WOMAC stiffness score | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness score rated on a Visual Analog Scale (VAS) of 0-100 mm. | 12 months from randomization |
| Patient's global assessment score | VAS 0-100 | 3 months from randomization |
| Patient's global assessment score | VAS 0-100 | 6 months from randomization |
| Patient's global assessment score | VAS 0-100 | 12 months from randomization |
| PROMIS sleep disturbance OA Knee- Short Form 6a | PROMIS sleep disturbance OA knee raw score ranges between 6-30 and the T score ranges between 29.8-76.1, with higher scores indicates greater sleep disturbance. | 3 months from randomization |
| PROMIS sleep disturbance OA Knee- Short Form 6a | PROMIS sleep disturbance OA knee raw score ranges between 6-30 and the T score ranges between 29.8-76.1, with higher scores indicates greater sleep disturbance. | 6 months from randomization |
| PROMIS sleep disturbance OA Knee- Short Form 6a | PROMIS sleep disturbance OA knee raw score ranges between 6-30 and the T score ranges between 29.8-76.1, with higher scores indicates greater sleep disturbance. | 12 months from randomization |
| Beck Depression Inventory-II score | The Beck Depression Inventory-II score ranges between 0-63, with higher scores indicating more severe depression symptoms. | 3 months from randomization |
| Beck Depression Inventory-II score | The Beck Depression Inventory-II score ranges between 0-63, with higher scores indicating more severe depression symptoms. | 6 months from randomization |
| Beck Depression Inventory-II score | The Beck Depression Inventory-II score ranges between 0-63, with higher scores indicating more severe depression symptoms. | 12 months from randomization |
| SF-12 MCS score | The SF-12 Mental Component Score ranges between 0-100. | 3 months from randomization |
| SF-12 MCS score | The SF-12 Mental Component Score ranges between 0-100. | 6 months from randomization |
| SF-12 MCS score | The SF-12 Mental Component Score ranges between 0-100. | 12 months from randomization |
| OMERACT/OARSI responder | Number of participants who meet the OMERACT/OARSI responder criteria | 3 months from randomization |
| OMERACT/OARSI responder | Number of participants who meet the OMERACT/OARSI responder criteria | 6 months from randomization |
| OMERACT/OARSI responder | Number of participants who meet the OMERACT/OARSI responder criteria | 12 months from randomization |
| Receipt of knee surgery | Number of Participants who receive knee surgery. | 12 months from randomization |
| Pain medication use | 3 months from randomization |
| Pain medication use | 6 months from randomization |
| Pain medication use | 12 months from randomization |
| Boston Medical Center |
| Principal Investigator |
| Helen Lavetrsky, MD, MS | University of California, Los Angeles | Principal Investigator |
| D012216 |
| Rheumatic Diseases |