Telehealth Exercise and Mindfulness for Pain in Osteoarthritis

Not Applicable

Completed

Conditions: Knee Osteoarthritis

Interventions: Behavioral: Exercise
Behavioral: Mindful Exercise program

Registration Number: NCT05524116

Lead Sponsor: Boston University Charles River Campus

Brief 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.

Detailed Description: In this RCT, the feasibility of an 8-week telehealth mindful exercise intervention compared to an 8-week telehealth exercise only intervention for people with knee osteoarthritis (OA) will be assessed. Forty adults with knee OA will be assigned to either a mindful exercise arm OR exercise arm. Both interventions will be delivered via real-time videoconferencing in a group setting (n=8-10 per group). All participants will be administered questionnaires for self-reported symptoms, mood, quality of life, etc. throughout the study period. Participants will be given the choice to opt in for in-person data collection visits wherein their physical function, muscle strength, sensitivity to painful stimuli, and brain function will be assessed before and at the end of the interventions. At the end of the 8-week interventions, 10 participants will be purposively sampled from each arm (n=20 total) for individual interviews to determine acceptability of the telehealth interventions. Feasibility of the intervention will be determined post-intervention by outcome measures such as recruitment rate, retention rate, and adherence.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 45

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group TX (Telehealth Exercise)	Exercise	Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth.
Group TMX (Telehealth Exercise and Mindfulness)	Mindful Exercise program	Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth.

Primary Outcome Measures

Name	Time	Method
Attendance	post-intervention (at 8-weeks)	Proportion of sessions attended
Retention Rate	post-intervention visit (at the end of 8-weeks)	Proportion of participants who complete patient-reported outcome surveys
Recruitment	through the recruitment process, up to 6 months from the start of the study	Number of participants that are randomized for the study
Participant Feedback Survey	8-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	8-week	Custom 4-item (0-10 scale) to determine satisfaction with individual components of the intervention (i.e.,, exercise, mindfulness, telehealth, and overall satisfaction). There are 4 items and each item is scored separately. Higher scores for each item mean greater satisfaction for that dimension.

Secondary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score	baseline, 8-week, 14-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.
Pain, Enjoyment, General Activity Scale	baseline, 8-week, 14-week	Assesses Pain Intensity and Interference. the response range is 0-10; the PEG scale score is the mean of the three individual item scores. Higher scores represent worse pain.
Numeric Rating Scale - Nominated Activity	baseline, 8-week, 14-week	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 Global Impression of Change	8-week, 14-week	participant's rating of change in condition on a 14-point scale ranging from "a very great deal worse" to "a very great deal better". Values range from -7 to +7 (excluding 0). Score \>=1 represent improvement and scores \<= -1 represent worsening.
Patient Global Assessment of Osteoarthritis	baseline, 8-week, 14-week	participant's assessment of impact of osteoarthritis on their general health on a 0-100 mm scale. higher scores represent higher impact of disease or worse global health
Pain Catastrophizing Scale	baseline, 8-week	3-item scale which measures of catastrophizing related to pain. Each item is rated on a 5-point scale: 0 (Not at all) to 4 (all the time).
Widespread Pain Index Symptom Severity Scale	baseline, 8-week	self-report on severity of cognitive symptoms such as fatigue, trouble thinking or remembering, waking up tired, and other physical symptoms such as headache, dizziness, etc. Each symptom is scored on a 4-point scale where 0 indicates no problem and 3 indicates severe problem. Scores are calculated by summing items, with higher scores (out of a maximum score of 12) indicating greater symptom severity.
Pain DETECT	baseline, 8-week	self-report measure on presence of neuropathic pain. each question is scored from 0 to 5 where higher scores indicate higher gradation of pain. The final score is between -1 and 38 and a score of 19 and higher indicates higher likelihood of neuropathic pain
Patient Health Questionnaire 8-item	baseline, 8-week, 14-week	8-item questionnaire assessing depression symptoms. Each question is scored from 0 to 3 where higher scores indicate higher frequency of experiencing depressive symptoms. Total score is the sum of individual item scores. Score range is 0-24. Higher total scores indicate greater severity of depression
Cognitive and Affective Mindfulness Scale - Revised	baseline, 8-week, 14-week	12-item scale on dispositional mindfulness. Items are rated on a 4-point Likert scale from 1 (rarely/not at all) to 4 (almost always). Scores on the scale are summed. Higher scores reflect greater mindfulness.
Fear Avoidance Beliefs Questionnaire - Physical Activity	baseline, 8-week	4-item questionnaire to determine how one's fear avoidance beliefs contributes to the cognitive/affective part of their knee pain. Each item is scored from 0 to 6. Total scores are summation of each item scores. Range is 0-24. Higher total scores indicate greater fear of physical activity
Arthritis Self Efficacy Scale	baseline, 8-week	Questionnaire to assess confidence in one's capacity to function despite pain. Each item in the questionnaire is scored on a 1-10 scale. It provides three subscales of pain, function, and other symptoms calculated as average of items contributing to that subscale. Range for each subscale is 1-10. Higher scores indicate greater self-efficacy to manage osteoarthritis.
Chronic Pain Self-efficacy Questionnaire	baseline, 8-week	Measures three domains of pain self-efficacy: pain management, physical functioning, and coping with symptoms. Each item is scored on a scale of 0 (very uncertain) to 100 (very certain). Score for each domain is the average of all items contributing to that domain. Higher total scores indicate greater self-efficacy to manage one's chronic pain.