N/A
N=40
Telehealth Exercise and Mindfulness for Pain in Osteoarthritis
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT05524116 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Recruitment — 19; 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindful Exercise program (Behavioral); Exercise (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Boston University Charles River Campus
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment |
19; 21 | — |
| PRIMARY Attendance |
68; 54 | — |
| PRIMARY Retention Rate |
19; 18 | — |
| PRIMARY Participant Feedback Survey |
3.56; 3.29; 3.44; 3.35; 3.33; 3.38 | — |
| PRIMARY Satisfaction Scale |
8.1; 8.2; 7.3; 8.1; 7.9; 7.9 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score |
61.3; 57.7; 63.7; 61.8; 63.8; 64.2 | — |
| SECONDARY Pain, Enjoyment, General Activity Scale |
4.9; 5.4; 4; 3.9; 3.9; 3.4 | — |
| SECONDARY Numeric Rating Scale - Nominated Activity |
6.1; 6.5; 5.1; 5.2; 4.8; 4.8 | — |
| SECONDARY Participant Global Impression of Change |
2.2; 2.4; 1.4; 2.2 | — |
| SECONDARY Patient Global Assessment of Osteoarthritis |
59.8; 63.7; 64.5; 65.7; 60.2; 68.7 | — |
| SECONDARY Pain Catastrophizing Scale |
3.5; 3.9; 3.4; 3.1 | — |
| SECONDARY Widespread Pain Index Symptom Severity Scale |
3.9; 3.1; 4.1; 3.7 | — |
| SECONDARY Pain DETECT |
9.8; 8.5; 9.4; 7.6 | — |
| SECONDARY Patient Health Questionnaire 8-item |
4.6; 3; 3.7; 3.9; 3.9; 4.1 | — |
| SECONDARY Cognitive and Affective Mindfulness Scale - Revised |
35.3; 37.4; 33.9; 36.4; 35.2; 37.3 | — |
| SECONDARY Fear Avoidance Beliefs Questionnaire - Physical Activity |
18.3; 15.5; 16.7; 14.8 | — |
| SECONDARY Arthritis Self Efficacy Scale |
6.5; 6.1; 7.1; 6.2; 8; 7.7 | — |
| SECONDARY Chronic Pain Self-efficacy Questionnaire |
71.5; 66.2; 66.8; 66.9; 86; 81.4 | — |
Summary
This is a parallel-arm mixed-methods randomized controlled trial to investigate the feasibility of telehealth delivered mindful exercise vs. usual exercise interventions for people with knee osteoarthritis.
Eligibility Criteria
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, 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 a 11-point numeric rating scale during previous week
- 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
Data sourced from ClinicalTrials.gov (NCT05524116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.