Clinical trial NCT06384898: Remote Tai Chi for Knee Osteoarthritis
Official title: Remote Tai Chi for Knee Osteoarthritis: An Embedded Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Pragmatic Clinical Trial
Implementation Science
Mind-body Therapies
Tai Chi
Knee Osteoarthritis
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Boston Medical Center
name: University of California, Los Angeles
name: The Cleveland Clinic
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-04-25
Enrollment: 480
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: WOMAC Pain Score
timeFrame: 3 months from randomization
Secondary outcomes:
measure: PROMIS Pain Interference score
timeFrame: 3 months from randomization
measure: SF-12 PCS score
timeFrame: 3 months from randomization
measure: Number of knee joint injections
timeFrame: 12 months from randomization
Other outcomes:
measure: WOMAC Pain Score
timeFrame: 6 months from randomization
measure: WOMAC Pain Score
timeFrame: 12 months from randomization
measure: PROMIS Pain Interference score
timeFrame: 6 months from randomization
measure: PROMIS Pain Interference score
timeFrame: 12 months from randomization
measure: SF-12 PCS score
timeFrame: 6 months from randomization
measure: SF-12 PCS score
timeFrame: 12 months from randomization
measure: WOMAC total score
timeFrame: 3 months from randomization
measure: WOMAC total score
timeFrame: 6 months from randomization
measure: WOMAC total score
timeFrame: 12 months from randomization
measure: WOMAC Pain Score on nominated activity chosen at baseline
timeFrame: 3 months from randomization
measure: WOMAC Pain Score on nominated activity chosen at baseline
timeFrame: 6 months from randomization
measure: WOMAC Pain Score on nominated activity chosen at baseline
timeFrame: 12 months from randomization
measure: WOMAC function score
timeFrame: 3 months from randomization
measure: WOMAC function score
timeFrame: 6 months from randomization
measure: WOMAC function score
timeFrame: 12 months from randomization
measure: WOMAC stiffness score
timeFrame: 3 months from randomization
measure: WOMAC stiffness score
timeFrame: 6 months from randomization
measure: WOMAC stiffness score
timeFrame: 12 months from randomization
measure: Patient's global assessment score
timeFrame: 3 months from randomization
measure: Patient's global assessment score
timeFrame: 6 months from randomization
measure: Patient's global assessment score
timeFrame: 12 months from randomization
measure: PROMIS sleep disturbance OA Knee- Short Form 6a
timeFrame: 3 months from randomization
measure: PROMIS sleep disturbance OA Knee- Short Form 6a
timeFrame: 6 months from randomization
measure: PROMIS sleep disturbance OA Knee- Short Form 6a
timeFrame: 12 months from randomization
measure: Beck Depression Inventory-II score
timeFrame: 3 months from randomization
measure: Beck Depression Inventory-II score
timeFrame: 6 months from randomization
measure: Beck Depression Inventory-II score
timeFrame: 12 months from randomization
measure: SF-12 MCS score
timeFrame: 3 months from randomization
measure: SF-12 MCS score
timeFrame: 6 months from randomization
measure: SF-12 MCS score
timeFrame: 12 months from randomization
measure: OMERACT/OARSI responder
timeFrame: 3 months from randomization
measure: OMERACT/OARSI responder
timeFrame: 6 months from randomization
measure: OMERACT/OARSI responder
timeFrame: 12 months from randomization
measure: Receipt of knee surgery
timeFrame: 12 months from randomization
measure: Pain medication use
timeFrame: 3 months from randomization
measure: Pain medication use
timeFrame: 6 months from randomization
measure: Pain medication use
timeFrame: 12 months from randomization
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Chenchen Wang, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Robert Saper, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Eric Roseen, DC, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Helen Lavetrsky, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: