Knee Osteoarthritis
Conditions
Keywords
Pragmatic Clinical Trial, Implementation Science, Mind-body Therapies, Tai Chi, Knee Osteoarthritis
Brief summary
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: * Compared to routine care, will patients with Knee OA receiving remote Tai Chi exhibit greater improvement in knee-related pain (WOMAC pain score, primary outcome), pain interference (PROMIS-Pain Interference, secondary outcome), and health-related quality of life at 3 months? * Does remote tai chi decreases healthcare utilization and analgesic use over the one-year study period? 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.
Detailed description
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.
Interventions
OTHERRemote Tai Chi
Tai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements.
Sponsors
Tufts Medical Center
Boston Medical Center
University of California, Los Angeles
The Cleveland Clinic
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age 50 years or older * Treating clinician diagnosis of knee osteoarthritis * Have a score of 40 (visual analog version) or greater on at least 1 of the 5 questions in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (range of 0 to 100, with higher scores indicating greater pain) at baseline. * Able to provide informed consent * If randomized to the Routine Care group, willing to abstain from Tai Chi programs until completion of the study * If randomized to the Tai Chi group, willing to comply with the Tai Chi program (twice-a-week remote sessions for 12 weeks) * Has access to a home computer or device that will allow telehealth (bidirectional audio and video) delivery of the intervention * Is an active patient at one of the 4 participating healthcare system
Exclusion criteria
* Currently practicing Tai Chi * Serious medical conditions (e.g., dementia, significant neurological deficits or neurodegenerative disorder, active cancer treatment, psychosis, sensory deficits) limiting the participant's ability to participate in the Tai Chi safely, as determined by the principal investigators * Unable to walk without a cane or other assistive device * Any previous or scheduled knee replacement * Reports severe depression defined by a Beck Depression Inventory (BDI-II) score of 29 or more. * Reports suicidal ideations defined by a score on BDI-II item of 2 or 3 ('I would like to kill myself' or 'I would kill myself if I had the chance'). * Not English speaking * Enrollment in any other clinical trial within the last 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WOMAC Pain Score | 3 months from randomization | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain Interference score | 3 months from randomization | 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. |
| SF-12 PCS score | 3 months from randomization | 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. |
| Number of knee joint injections | 12 months from randomization | Total number of intra-articular injections identified through EHR and patient questionnaires. |
Countries
United States
Contacts
CONTACTChenchen Wang, MD, MSc
CONTACTSherwood Alexis, MHA, MBA
PRINCIPAL_INVESTIGATORChenchen Wang, MD, MSc
Tufts Medical Center
PRINCIPAL_INVESTIGATORRobert Saper, MD, MPH
The Cleveland Clinic
PRINCIPAL_INVESTIGATOREric Roseen, DC, PhD
Boston Medical Center
PRINCIPAL_INVESTIGATORHelen Lavetrsky, MD, MS
University of California, Los Angeles
Outcome results
None listed