Using neuromodulation to enhance exercise effects for knee osteoarthritis
Enhancing Modulation Effects of Baduanjin Through Non-invasive Neuromodulation for Knee Osteoarthritis
PHASE2 · Massachusetts General Hospital · NCT05839535
This study is testing if combining brain stimulation with special exercises can help people with knee osteoarthritis feel less pain and move better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Charlestown, Massachusetts) |
| Trial ID | NCT05839535 on ClinicalTrials.gov |
What this trial studies
This study investigates the neurobiological mechanisms behind Baduanjin exercises combined with neuromodulation techniques for patients with knee osteoarthritis. Participants will undergo brain imaging and receive either active or sham transcranial direct current stimulation (tDCS) while engaging in exercise programs. The goal is to better understand how mind-body exercises can alleviate pain and improve function in individuals suffering from this condition. The study will last for 12 weeks and aims to provide insights that could lead to new pain management strategies.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45-75 who have been diagnosed with knee osteoarthritis and are physically able to participate in the exercise program.
Not a fit: Patients who have engaged in mind-body interventions or regular exercise in the past year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and functional outcomes for patients with knee osteoarthritis.
How similar studies have performed: While this specific approach is novel, similar studies exploring mind-body interventions have shown promising results in pain management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Volunteers 45-75 years of age * Meet the Classification Criteria of the American College of Rheumatology for osteoarthritis of the right and/or left knee for at least the past 3 months; * Physically able to participate in the BDJ and stretching control education programs * Willing to complete the 12-week study * Can participate in MRI scan * Ability to read and understand English; English can be a second language provided that the patient feels he or she can understand all the questions used in the assessment measures 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 * Serious medical conditions limiting ability of patient to participate in the study, such as symptomatic cardiovascular disease, symptomatic pulmonary disease requiring supplemental oxygen, uncontrolled metabolic diseases, severe renal and liver disease * Has had intra-articular steroid injections or reconstructive surgery in the prior 3 months on the affected knee; any intra-articular hyaluronic acid injections in the previous 6 months * Patient Mini-Mental Status Examination score below 24 \[293\] * Unable to walk without a cane or other assistive device * The intent to undergo surgery during the time of involvement in the study * Plan to permanently relocate from the region during the trial period
Where this trial is running
Charlestown, Massachusetts
- Massachusetts General Hospital — Charlestown, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Jian Kong
- Email: jkong2@mgh.harvard.edu
- Phone: 617-7267893
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Osteoarthritis