Telehealth Exercise and Mindfulness for Pain in Osteoarthritis - Stage 1B
Recruiting · NCT06684587 · Interventional (participants receive a specific treatment) · Lead sponsor: Boston University Charles River Campus
View the official record on ClinicalTrials.gov →Interventions studied
Exercise ProgramMindful Exercise
What this trial is about
The goal of this randomized controlled trial (RCT) is to test the feasibility of an 10-week telehealth mindful exercise intervention compared to a telehealth exercise only intervention for people with knee osteoarthritis (OA). This RCT will be fully digital with all recruitment, assessments, and intervention being conducted remotely.
Who can take part
Age range
50 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Meet National Institute for Health and Clinical Excellence clinical guidelines for knee osteoarthritis (i.e., age ≥ 50 years, presence of activity related pain, no morning knee stiffness or presence of morning knee stiffness ≤ 30 minutes)
- BMI\<40
- Knee pain on most days for 3 months or more
- Average overall knee pain severity of ≥ 4 on an 11-point numeric rating scale over last 7 days, at least 2 weeks apart
- Able to attend remote sessions
- Can speak and understand English at a sufficient level to understand the study procedures and informed consent.
- Available for study duration
Exclusion criteria
- Contraindications to exercise
- Other pain in lower back or legs that is greater than knee pain
- Received physical therapy treatment for knee OA in the past 6 months or currently receiving physical therapy
- Received any mindfulness programs such as Tai Chi, meditation, etc. in the past 6 months or currently receiving such program
- Currently receiving chemotherapy or radiation therapy for cancer except non-melanoma skin cancer
- History of other disease that may involve the index joint including inflammatory joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease related arthropathy), crystalline disease (eg, gout or pseudogout), lupus erythematosus, knee joint infections, Paget's disease affecting the knee, or knee joint tumors.
- Any knee surgery in the previous 6 months
- Joint replacement in either hip or ankle
- Previous knee osteotomy partial or total knee replacement in either knee
- Planned major treatment for knee OA (e.g., surgery, injections, physical therapy) during the study period
- Planned major surgery in the next 6 months
- Corticosteroid or hyaluronic acid injections in either knee in the previous 3 months
- Neurological conditions that impacts motor functioning (e.g., stroke, Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, diabetic neuropathy, etc).
- Pregnancy (self-report)
- Participation in another clinical trial for any joint or muscle pain
- Suspected or known drugs or alcohol abuse
Where it is running
1 location listed across 1 US state.
- Boston University - Boston, Massachusetts, United States