Remote Tai Chi for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— TAICHIKNEE  

Official title:

Remote Tai Chi for Knee Osteoarthritis: An Embedded Pragmatic Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384898
• Other study ID #: STUDY00002259
• Secondary ID: UH3AT012413
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: October 2027

Study information

• Verified date: May 2024
• Source: Tufts Medical Center
• Contact: Chenchen Wang, MD, MSc
• Phone: 617-636-3251
• Email: Chenchen.Wang[@]tuftsmedicine.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

• Does remote Tai Chi improve the extent to which pain interferes with physical, mental, and social activities (PROMIS-Pain Interference at 3 months, primary outcome), as well as knee pain and function (WOMAC subscales) and analgesic use (secondary outcomes)

• Does remote tai chi decreases healthcare utilization?

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: October 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

Inclusion Criteria:

• Age 50 years or older

• Treating clinician diagnosis of knee osteoarthritis

• PROMIS Pain Interference Short Form 6b; score 4 or 5 on at least 1 of 6 questions (possible answers to each question range from 1 to 5)

• Able to provide informed consent

• If randomized to the Routine Care group, willing to abstain from Tai Chi programs until completion of the study

• Has access to a home computer or device that will allow telehealth 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 reconstructive surgery

• Beck Depression Inventory (BDI-II) suicide item (#9) score 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Remote Tai Chi
Tai Chi mind-body exercise is a complex, multi-component nonpharmacological intervention integrating physical, psychological, emotional, and behavioral elements.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
Tufts Medical Center	Boston Medical Center, National Center for Complementary and Integrative Health (NCCIH), The Cleveland Clinic, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	WOMAC Pain Score	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score rated on a Visual Analog Scale (VAS) of 0-100 mm.	12 months from randomization
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Patient's global assessment score	VAS 0-100	3 months from randomization
Other	Patient's global assessment score	VAS 0-100	6 months from randomization
Other	Patient's global assessment score	VAS 0-100	12 months from randomization
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	SF-12 MCS score	The SF-12 Mental Component Score ranges between 0-100.	3 months from randomization
Other	SF-12 MCS score	The SF-12 Mental Component Score ranges between 0-100.	6 months from randomization
Other	SF-12 MCS score	The SF-12 Mental Component Score ranges between 0-100.	12 months from randomization
Other	Receipt of knee surgery	Number of Participants who receive knee surgery.	12 months from randomization
Other	OMERACT/OARSI responder	Number of participants who meet the OMERACT/OARSI responder criteria	3 months from randomization
Other	OMERACT/OARSI responder	Number of participants who meet the OMERACT/OARSI responder criteria	6 months from randomization
Other	OMERACT/OARSI responder	Number of participants who meet the OMERACT/OARSI responder criteria	12 months from randomization
Other	Pain medication use		3 months from randomization
Other	Pain medication use		6 months from randomization
Other	Pain medication use		12 months from randomization
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of knee joint injections	Total number of intra-articular injections identified through EHR and patient questionnaires.	12 months from randomization
Secondary	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
Secondary	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