Neuromodulation and Exercise for Osteoarthritis

Overseen By Jian Kong

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Disqualifiers: Cardiovascular, Pulmonary, Metabolic, Renal, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

140 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will combine brain imaging and neuromodulation tools to investigate the underlying neurobiological mechanisms of exercises. The findings will enhance our understanding of the mechanisms underlying mind-body exercise and facilitate the development of new pain management approaches.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment Neuromodulation and Exercise for Osteoarthritis?

Research suggests that Baduanjin, a traditional exercise included in the treatment, can help improve symptoms of knee osteoarthritis and enhance balance and quality of life in older adults. This indicates potential benefits for osteoarthritis patients. ^{1 2 3 4 5}

Is Baduanjin exercise safe for humans?

Baduanjin exercise, a traditional Chinese exercise routine, has been studied for its safety and benefits in conditions like knee osteoarthritis and osteoporosis. Research suggests it is generally safe for humans, as it combines gentle movements with breathing and meditation. ^{1 2 5 6 7}

How is the Baduanjin treatment different from other treatments for osteoarthritis?

Baduanjin is a unique form of low-intensity aerobic exercise that combines breathing, body movement, and meditation, making it different from typical drug treatments for osteoarthritis. It is a traditional Chinese exercise with a history of over 1000 years, specifically designed to improve pain and balance in conditions like knee osteoarthritis. ^{1 2 5 7 8}

Eligibility Criteria

This trial is for volunteers aged 45-75 with knee osteoarthritis diagnosed by the American College of Rheumatology criteria, able to do Baduanjin (BDJ) exercises and stretching, willing to commit to a 12-week study, can undergo MRI scans, and understand English well enough for assessments.

Inclusion Criteria

I am between 45 and 75 years old.

I have been diagnosed with knee osteoarthritis for at least 3 months.

Willing to complete the 12-week study

Exclusion Criteria

Has performed BDJ, Tai Chi, Yoga, other mind-body intervention, physical therapy, or routine exercise (running, cycling, etc.) regularly in the past year

Patient Mini-Mental Status Examination score below 24

I need a cane or another device to walk.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Baduanjin exercises combined with real or sham tDCS for knee osteoarthritis

12 weeks

Regular visits for neuromodulation and exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up assessments at 24 weeks

Treatment Details

Interventions

• BDJ
• Exercise
• Sham tDCS
• tDCS

Trial Overview The study tests how brain stimulation (tDCS) combined with BDJ exercise affects knee osteoarthritis. Participants will be randomly assigned to receive either real or sham tDCS while performing BDJ or other exercises. Brain imaging will help understand pain management mechanisms.

Participant Groups

Group I: BDJ + real tDCS Active Control 2 Interventions

Group II: Exercise + real tDCS Active Control 2 Interventions

Group III: BDJ + sham tDCS Active Control 2 Interventions

Group IV: Exercise + sham tDCS Active Control 2 Interventions

BDJ is already approved in China for the following indications:

Approved in China as Baduanjin for:

• Knee osteoarthritis

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

The study involving 28 female patients with knee osteoarthritis showed that Baduanjin exercise significantly reduced pain, stiffness, and physical disability compared to a control group, indicating its efficacy as a treatment option.

No adverse events were reported, suggesting that Baduanjin is a safe and feasible exercise intervention for improving knee function and strength in patients with osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baduanjin alleviates the symptoms of knee osteoarthritis. An, B., Dai, K., Zhu, Z., et al.[2022]

Baduanjin (BDJ) exercise has been shown to significantly improve bone mineral density (BMD) in patients with postmenopausal and senile osteoporosis, based on a meta-analysis of 13 randomized controlled trials involving 919 patients.

BDJ exercise not only enhances BMD but also improves balance and reduces pain, indicating its potential as a complementary treatment for osteoporosis, although further high-quality research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baduanjin exercise: A potential promising therapy toward osteoporosis. Sun, C., Qi, B., Huang, X., et al.[2022]

A pilot study involving 16 older adults showed that 12 weeks of ba-duan-jin (BDJ) training significantly improved balance and quality of life, as measured by various tests including the Single-Leg Stance and Tinetti Balance Test.

BDJ training effectively decreased the fear of falling and enhanced lower extremity strength, making it a promising rehabilitation method for improving motor function in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Sitting Ba-Duan-Jin Exercises on Balance and Quality of Life Among Older Adults: A Preliminary Study. Bao, X., Qiu, QX., Shao, YJ., et al.[2021]

Baduanjin, a traditional Chinese exercise, has been shown to be safe and beneficial for various health conditions, with no serious adverse events reported in the studies reviewed, which included 614 randomized controlled trials and a total of 810 publications.

Despite the positive findings, the studies varied significantly in their methods, such as style and duration of practice, indicating a need for standardization and higher-quality research to better validate the health benefits of Baduanjin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristic of Clinical Studies on Baduanjin during 2000-2019: A Comprehensive Review. Zhou, J., Yu, Y., Cao, B., et al.[2020]

A randomized controlled trial involving 160 participants will assess the effectiveness of Baduanjin (BDJ) exercise combined with Calcium carbonate and D3 over 24 weeks in improving pain and balance in patients with osteoporosis.

The study aims to demonstrate that BDJ exercise can serve as a beneficial non-drug intervention to enhance balance, reduce pain, and prevent bone loss and falls in individuals with osteoporosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Baduanjin exercise on primary osteoporosis: study protocol for randomized controlled trial. Sun, C., Chen, M., Wang, X., et al.[2023]

This systematic review aims to evaluate the efficacy and safety of Baduanjin, a traditional Chinese mind-body exercise, for treating knee osteoarthritis (KOA) in older adults, highlighting its potential clinical benefits.

The review will analyze randomized controlled trials and assess outcomes using the Western Ontario and McMaster Universities Osteoarthritis Index, providing evidence on whether Baduanjin can improve physical condition and quality of life for KOA patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baduanjin exercise for patients with knee osteoarthritis: A protocol for systematic review and meta-analysis. Li, J., Yin, S., Li, R., et al.[2023]

A one-year Baduanjin exercise program significantly improved knee pain, stiffness, and physical function in patients with knee osteoarthritis, as measured by various health indices.

The study, involving 22 patients who completed the program, showed no adverse effects, indicating that Baduanjin is a safe and feasible exercise option for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Baduanjin () exercise on knee osteoarthritis: a one-year study. An, BC., Wang, Y., Jiang, X., et al.[2021]

Baduanjin exercise significantly improved pain, stiffness, and physical function in knee osteoarthritis patients compared to a waiting list control, based on a meta-analysis of 7 randomized controlled trials involving 424 participants.

When combined with NSAID therapies, Baduanjin exercise led to greater improvements in overall knee function and pain reduction compared to NSAIDs alone, indicating its potential as an effective complementary treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Baduanjin exercise for knee osteoarthritis: A systematic review and meta-analysis. Zeng, ZP., Liu, YB., Fang, J., et al.[2020]

References

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

Baduanjin alleviates the symptoms of knee osteoarthritis. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Baduanjin exercise: A potential promising therapy toward osteoporosis. [2022]

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

Effect of Sitting Ba-Duan-Jin Exercises on Balance and Quality of Life Among Older Adults: A Preliminary Study. [2021]

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

Characteristic of Clinical Studies on Baduanjin during 2000-2019: A Comprehensive Review. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Effect of Baduanjin exercise on primary osteoporosis: study protocol for randomized controlled trial. [2023]

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

Baduanjin exercise for patients with knee osteoarthritis: A protocol for systematic review and meta-analysis. [2023]

7. China pubmed.ncbi.nlm.nih.gov

Effects of Baduanjin () exercise on knee osteoarthritis: a one-year study. [2021]

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

Effects of Baduanjin exercise for knee osteoarthritis: A systematic review and meta-analysis. [2020]