Remote Tai Chi for Knee Osteoarthritis

(TAICHIKNEE Trial)

Overseen By William Harvey, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts Medical Center

Disqualifiers: Tai chi practice, Dementia, Neuro disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 27

Duration: 12 weeks

480 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems that the focus is on adding Tai Chi to your routine care, so you may not need to stop your medications, but it's best to confirm with the trial organizers.

What data supports the effectiveness of the treatment Remote Tai Chi for knee osteoarthritis?

Research shows that Tai Chi can help reduce pain and improve physical function in people with knee osteoarthritis. Some studies found significant pain reduction and better daily activity performance compared to routine treatments. ^{1 2 3 4 5}

Is Remote Tai Chi safe for humans?

Research on Tai Chi, including remote versions, generally shows it to be safe for humans, with few reports of adverse events (unwanted side effects). ^{1 5 6 7 8}

How is Remote Tai Chi different from other treatments for knee osteoarthritis?

Remote Tai Chi is unique because it allows patients to practice Tai Chi, a gentle exercise from an ancient Chinese martial art, from their own homes, making it accessible and convenient. Unlike traditional in-person exercise programs, this remote approach can be particularly beneficial for those with mobility issues or who live far from treatment centers. ^{1 8 9 10 11}

Research Team

Chenchen Wang, MD, MSc

Principal Investigator

Tufts Medical Center

Robert Saper, MD, MPH

Principal Investigator

The Cleveland Clinic

Eric Roseen, DC, PhD

Principal Investigator

Boston Medical Center

Helen Lavetrsky, MD, MS

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for adults with knee osteoarthritis who experience pain that affects their daily activities. Participants will be randomly assigned to either add remote Tai Chi sessions to their routine care or continue with their usual treatment without Tai Chi.

Inclusion Criteria

Able to provide informed consent

Has access to a home computer or device that will allow telehealth delivery of the intervention

I am 50 years old or older.

Exclusion Criteria

I need a cane or another device to walk.

I have had reconstructive surgery before.

Currently practicing Tai Chi

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remote Tai Chi sessions twice a week for 3 months

12 weeks

24 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Evaluations at 3, 6, and 12 months

Open-label extension (optional)

Participants in the routine care group are offered access to Tai Chi session recordings after the trial

Post-trial

Treatment Details

Interventions

• Remote Tai Chi

Trial Overview The study is testing if practicing Tai Chi remotely can reduce the impact of knee pain on physical, mental, and social activities. It also looks at improvements in knee function and whether participants use fewer painkillers as a result.

Participant Groups

Group I: Tai Chi + Routine Care Experimental Treatment 1 Intervention

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.

Group II: Routine Care Active Control 1 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).

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

A 12-week tai chi program, consisting of group sessions followed by home training, significantly reduced knee pain and improved physical function in 41 elderly participants with knee osteoarthritis, compared to a control group that received health lectures.

Improvements in pain and function were observed during the intervention but disappeared after a six-week period of no tai chi practice, indicating the need for ongoing practice to maintain benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group and home-based tai chi in elderly subjects with knee osteoarthritis: a randomized controlled trial. Brismée, JM., Paige, RL., Chyu, MC., et al.[2022]

In a study of 40 individuals with knee osteoarthritis, Tai Chi significantly reduced pain and improved physical function compared to a control group, with notable improvements in WOMAC pain and function scores after 12 weeks.

Participants practicing Tai Chi also experienced enhancements in self-efficacy, depression levels, and overall quality of life, with no severe adverse events reported, indicating it is a safe and effective intervention for managing knee OA symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tai Chi is effective in treating knee osteoarthritis: a randomized controlled trial. Wang, C., Schmid, CH., Hibberd, PL., et al.[2022]

Tai Chi exercise significantly improves pain, stiffness, physical function, and dynamic balance in patients with knee osteoarthritis, based on a systematic review of 16 randomized controlled trials involving 986 participants.

No adverse events were reported, indicating that Tai Chi is a safe and effective non-pharmacological therapy for enhancing both physical and mental health in individuals with knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tai Chi exercise can ameliorate physical and mental health of patients with knee osteoarthritis: systematic review and meta-analysis. Hu, L., Wang, Y., Liu, X., et al.[2022]

A study involving 152 older adults with chronic hip or knee osteoarthritis showed that both hydrotherapy and Tai Chi classes led to significant improvements in pain and physical function after 12 weeks, with benefits sustained at 24 weeks.

Hydrotherapy classes resulted in greater improvements in physical performance measures compared to Tai Chi, and had higher attendance rates, suggesting it may be a more effective option for older individuals with osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity for osteoarthritis management: a randomized controlled clinical trial evaluating hydrotherapy or Tai Chi classes. Fransen, M., Nairn, L., Winstanley, J., et al.[2008]

Tai chi may help reduce pain in patients with knee osteoarthritis, as indicated by two out of five randomized clinical trials showing significant pain reduction compared to routine treatment.

However, the overall evidence for tai chi's effectiveness in improving physical function and pain reduction is not strong, highlighting the need for larger and longer-term studies with better controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tai chi for osteoarthritis: a systematic review. Lee, MS., Pittler, MH., Ernst, E.[2022]

T'ai chi has shown promising effects in reducing pain, improving physical function, and decreasing joint stiffness in patients with knee osteoarthritis, based on a meta-analysis of nine randomized clinical trials involving 256 participants.

Despite these positive findings, the overall evidence is limited due to significant methodological weaknesses in the studies, indicating a need for more rigorous research to confirm the efficacy of t'ai chi for osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

T'ai chi for the treatment of osteoarthritis: a systematic review and meta-analysis. Kang, JW., Lee, MS., Posadzki, P., et al.[2022]

Tai chi (TC) is generally safe, with no serious adverse events reported in a review of 153 randomized controlled trials, primarily involving older adults, although minor musculoskeletal issues like knee and back pain were noted.

Only 33% of the trials reported adverse events, and just 12% had a clear protocol for monitoring them, indicating that the inconsistent reporting limits our understanding of TC's safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do we really know about the safety of tai chi?: A systematic review of adverse event reports in randomized trials. Wayne, PM., Berkowitz, DL., Litrownik, DE., et al.[2022]

Tai Chi (TC) has been shown to effectively improve symptoms of knee osteoarthritis (KOA), including pain, stiffness, physical function, and mental quality of life, based on a review of seven systematic reviews and meta-analyses.

Despite these positive findings, the overall methodological quality of the studies was low, with only one deemed high quality, indicating that the results should be interpreted cautiously and highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Tai chi in knee osteoarthritis patients: An overview of systematic reviews and meta-analyses. Zhang, N., Cui, H., Li, H., et al.[2023]

A systematic review of 11 randomized trials involving 1861 participants found that remote exercise programs can lead to clinically meaningful improvements in knee pain for individuals with osteoarthritis, although only one trial showed significant differences between groups.

The most effective interventions included personalized communication to tailor the exercise programs, highlighting the importance of engagement in remote management strategies for knee OA pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of remote exercise programs in reducing pain for patients with knee osteoarthritis: A systematic review of randomized trials. McHugh, CG., Kostic, AM., Katz, JN., et al.[2022]

Teaching the 12-form Sun-style Tai Chi to mildly cognitively impaired elders can effectively relieve knee pain caused by osteoarthritis, making it a beneficial exercise option for this population.

The program highlights the need for tailored teaching strategies that accommodate the physical and cognitive challenges faced by older adults, ensuring safety and efficacy in their practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching Tai Chi to elders with osteoarthritis pain and mild cognitive impairment. Chang, JY., Tsai, PF., Woods, S., et al.[2021]

Teaching Tai Chi, specifically the 12-form Sun-style, to elders with mild cognitive impairment can effectively relieve knee pain caused by osteoarthritis.

The program demonstrates that with tailored teaching strategies, Tai Chi can be a unique and cost-effective intervention for improving the quality of life in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching Tai Chi to elders with osteoarthritis pain and mild cognitive impairment. Chang, JY., Tsai, PF., Woods, S., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Group and home-based tai chi in elderly subjects with knee osteoarthritis: a randomized controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Tai Chi is effective in treating knee osteoarthritis: a randomized controlled trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Tai Chi exercise can ameliorate physical and mental health of patients with knee osteoarthritis: systematic review and meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Physical activity for osteoarthritis management: a randomized controlled clinical trial evaluating hydrotherapy or Tai Chi classes. [2008]

5. Germany pubmed.ncbi.nlm.nih.gov

Tai chi for osteoarthritis: a systematic review. [2022]

6. England pubmed.ncbi.nlm.nih.gov

T'ai chi for the treatment of osteoarthritis: a systematic review and meta-analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

What do we really know about the safety of tai chi?: A systematic review of adverse event reports in randomized trials. [2022]

8. Scotland pubmed.ncbi.nlm.nih.gov

Effects of Tai chi in knee osteoarthritis patients: An overview of systematic reviews and meta-analyses. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Effectiveness of remote exercise programs in reducing pain for patients with knee osteoarthritis: A systematic review of randomized trials. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Teaching Tai Chi to elders with osteoarthritis pain and mild cognitive impairment. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Teaching Tai Chi to elders with osteoarthritis pain and mild cognitive impairment. [2021]