Telehealth Exercise and Mindfulness for Pain in Osteoarthritis - Stage 1B
- Conditions
- Knee Osteoarthritis
- Registration Number
- NCT06684587
- Lead Sponsor
- Boston University Charles River Campus
- Brief Summary
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.
- Detailed Description
In this RCT, 62 adults with knee osteoarthritis will be assigned to either an exercise arm or mindful exercise arm. Both interventions will be delivered via videoconferencing in a group setting. In both groups, participants will receive a supervised session twice a week for 10 weeks. Participants will also receive a home program. During the study period, participants will be asked to remotely complete brief surveys every week and longer surveys on pain, function, mood, and other symptoms at baseline, week 5, week 10, week 16, and week 22. These surveys will be about pain, function, mood, and other symptoms. Participants will complete digital wearable-sensor based assessments at baseline and week 10. Participants will also be asked to complete brief surveys each week during the study. Feasibility of the intervention will be determined post-intervention by outcome measures such as recruitment rate, retention rate, and adherence.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 62
- Meet National Institute for Health and Clinical Excellence clinical guidelines for knee osteoarthritis (i.e., age ≥ 50 years, presence of activity related pain, 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Recruitment Rate Throughout the recruitment process; up to 12 months from the start of the study Proportion of participants that are recruited for the study
Retention Rate Post-intervention visit (10-week) Proportion of participants who complete patient-reported outcome surveys.
Safety From first intervention session to week 22 # of intervention related adverse or serious adverse events
Attendance Throughout the intervention period (over 10-weeks) Proportion of sessions attended.
- Secondary Outcome Measures
Name Time Method Knee Injury and Osteoarthritis Outcome Score Baseline, 5-week, 10-week, 16-week, 22-week Patient-reported outcome for knee pain and disability; a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Numeric Rating Scale - Nominated Activity Weekly for 22 weeks Average rating of knee pain from 0-10, where 0 represents no pain and 10 represents worst pain imaginable, in the past week in a nominated activity selected at baseline.
Participant Feedback Survey 5-week, Post-intervention visit (10-week), Follow-up visit (22-week) Custom scale measuring feedback on interventionists and interventions. Scores range from 0-4 (0 - Strongly Disagree, 1 - Disagree, 2 - Neither Agree no Disagree, 3 - Agree, and 4 - Strongly Agree).
Satisfaction Scale Post-intervention visit (10-week), Follow-up visit (22-week) Custom 4-item (0-10 Likert scale) to determine satisfaction with individual components of the intervention.
Pain Catastrophizing Scale Baseline, 5-week, 10-week, 16-week, 22-week 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain. Each item is rated on a 5-point scale: 0 (Not at all) to 4 (all the time).
Participant Global Impression of Change 5-week, 10-week, 16-week, 22-week Participant's rating of change in condition on a 15-point scale. Higher scores represent improvement and lower scores represent worsening or no change in symptoms.
Tampa Scale of Kinesiophobia Baseline, 10-week, 22-week 17-item self-report checklist with a 4-point Likert scale (1 - Strongly disagree; 2 - Disagree; 3 - Agree; 4 - Strongly agree) to assess one's fear of movement. Scoring of items 4, 8, 12, and 16 must be reversed, where "strongly disagree" is 4 points, "disagree" is 3 points, "agree" is 2 points, and "strongly agree" is 1 point. Sum up the scores for all 17 items to obtain the total raw score, ranging from 17 to 68 points. Higher total scores indicate an increasing degree of kinesiophobia, with 17 indicating no kinesiophobia or negligible fear of movement and 68 representing the highest possible level of kinesiophobia.
Global Mindfulness Scale Baseline, 10-week, 22-week 13-item tool that assesses all five mindfulness factors: Allowance, Boundlessness, Open-Heartedness, Insight, and Presence.
Trial Locations
- Locations (1)
Boston University
🇺🇸Boston, Massachusetts, United States