Remote Tai Chi for Knee Osteoarthritis
ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-100
SponsorTufts Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 50 years or older with clinician diagnosis of knee osteoarthritis
Active patient within a participating healthcare system
A score of 40 (visual analog version) or greater on at least 1 item of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (range of 0 to 100, with higher scores indicating greater pain).
Ability to provide informed consent
Disqualifiers
Current participation in Tai Chi practice
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
Prior total knee replacement or planned total knee replacement during the study period
Inability to ambulate independently or rise from a chair without assistance
Trial design
Design model
Parallel
Treatments tested in this trial
Remote Tai Chi
Other interventionTai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements.
Treatment groups
480 Participants
are divided into 2 treatment groupsGroup A: Tai Chi + Routine CareExperimental treatment 1 intervention
Group B: Routine CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
WOMAC Pain Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame
3 months from randomizationSecondary outcomes
1
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.
Time frame
3 months from randomization2
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.
Time frame
3 months from randomization3
Number of knee joint injections
Total number of intra-articular injections identified through EHR and patient questionnaires.
Time frame
12 months from randomizationOther outcomes
1
WOMAC Pain Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame
6 months from randomization2
WOMAC Pain Score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.
Time frame
12 months from randomization3
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.
Time frame
6 months from randomization4
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.
Time frame
12 months from randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tufts Medical Center
Lead sponsor
Boston Medical Center
Collaborator
University of California, Los Angeles
Collaborator
The Cleveland Clinic
Collaborator
University of New Mexico
Collaborator
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Source ClinicalTrials.gov