Neuromodulation and Exercise for Osteoarthritis
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.12345Why 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.26789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Baduanjin exercises combined with real or sham tDCS for knee osteoarthritis
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BDJ
- Exercise
- Sham tDCS
- tDCS
BDJ is already approved in China for the following indications:
- Knee osteoarthritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor