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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the relationship between brain activity, exercise, and pain management in individuals with knee osteoarthritis. Researchers are using a technique called neuromodulation to determine its effectiveness in exercise-related pain relief. Participants will join different groups that combine exercise or a program called BDJ (Baduanjin, a form of traditional Chinese exercise) with either real or sham (inactive) neuromodulation. Ideal candidates for this trial have experienced knee osteoarthritis for at least three months and can engage in physical activities like BDJ and stretching. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that transcranial direct current stimulation (tDCS), whether used alone or with exercise, is generally safe for people with knee osteoarthritis. One study found that tDCS can reduce short-term pain and sensitivity to pain, indicating its safety. Most people tolerate tDCS well, experiencing only minor side effects like skin irritation where the electrodes are placed.

When combined with exercise, research suggests tDCS might improve movement and balance in people with knee osteoarthritis. This combination has been tested in other studies without major safety issues.

Since this trial is in the early stages, the complete safety profile of the treatment is still being explored, but early results are encouraging. The fact that multiple studies are testing tDCS suggests it is considered reasonably safe at this point. However, discussing potential risks with a doctor before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for osteoarthritis, which often include NSAIDs like ibuprofen or corticosteroid injections, this trial explores the combination of neuromodulation and exercise. Researchers are excited because transcranial direct current stimulation (tDCS) offers a non-invasive way to potentially enhance pain relief and improve joint function. In particular, the trial investigates how pairing real tDCS with exercise or BDJ (a novel therapeutic) might yield better results than traditional methods. This approach targets neural pathways directly, which could lead to quicker and more effective symptom management.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

In this trial, participants will join different treatment arms to evaluate the effectiveness of combining transcranial direct current stimulation (tDCS) with exercise or BDJ (Baduanjin). Previous studies have shown that tDCS can effectively reduce pain and improve physical function in people with knee osteoarthritis. Research indicates that combining tDCS with exercise can boost brain activity and enhance the brain's adaptability, aiding in pain reduction. For the BDJ treatment, adding tDCS can significantly improve movement, balance, and confidence in using the knee. This combined approach of exercise and tDCS has shown promise in enhancing the quality of life for people with osteoarthritis. Evidence suggests this method could be a valuable tool in managing osteoarthritis pain. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Physically able to participate in the BDJ and stretching control education programs

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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