Clinical trial NCT05524116: Telehealth Exercise and Mindfulness for Pain in Osteoarthritis
Official title: Telehealth Exercise and Mindfulness for Pain in Osteoarthritis: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: telehealth
exercise
mindfulness
pain
feasibility
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-arm randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recruitment
timeFrame: through the recruitment process, up to 6 months from the start of the study
measure: Attendance
timeFrame: post-intervention (at 8-weeks)
measure: Retention Rate
timeFrame: post-intervention visit (at the end of 8-weeks)
measure: Participant Feedback Survey
timeFrame: 8-week
measure: Satisfaction Scale
timeFrame: 8-week
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: baseline, 8-week, 14-week
measure: Pain, Enjoyment, General Activity Scale
timeFrame: baseline, 8-week, 14-week
measure: Numeric Rating Scale - Nominated Activity
timeFrame: baseline, 8-week, 14-week
measure: Participant Global Impression of Change
timeFrame: 8-week, 14-week
measure: Patient Global Assessment of Osteoarthritis
timeFrame: baseline, 8-week, 14-week
measure: Pain Catastrophizing Scale
timeFrame: baseline, 8-week
measure: Widespread Pain Index Symptom Severity Scale
timeFrame: baseline, 8-week
measure: Pain DETECT
timeFrame: baseline, 8-week
measure: Patient Health Questionnaire 8-item
timeFrame: baseline, 8-week, 14-week
measure: Cognitive and Affective Mindfulness Scale - Revised
timeFrame: baseline, 8-week, 14-week
measure: Fear Avoidance Beliefs Questionnaire - Physical Activity
timeFrame: baseline, 8-week
measure: Arthritis Self Efficacy Scale
timeFrame: baseline, 8-week
measure: Chronic Pain Self-efficacy Questionnaire
timeFrame: baseline, 8-week
Other outcomes:
measure: Arthritis - Rapid Estimate of Adult Literacy in Medicine (A-REALM)
timeFrame: baseline
measure: Sit to Stand Test [OPTIONAL IN-PERSON VISIT]
timeFrame: baseline, 8-week
measure: 6-minute Walk Test [OPTIONAL IN-PERSON VISIT]
timeFrame: baseline, 8-week
measure: 7-meter Walk Test [OPTIONAL IN-PERSON VISIT]
timeFrame: baseline, 8-week
measure: Stair Climb Test [OPTIONAL IN-PERSON VISIT]
timeFrame: baseline, 8-week
measure: Pressure Pain Threshold [OPTIONAL IN-PERSON VISIT]
timeFrame: baseline, 8-week
measure: Mechanical Temporal Summation [OPTIONAL IN-PERSON VISIT]
timeFrame: baseline, 8-week
measure: Conditioned Pain Modulation [OPTIONAL IN-PERSON VISIT]
timeFrame: baseline, 8-week
measure: Exercise Induced Hypoalgesia [OPTIONAL IN-PERSON VISIT]
timeFrame: baseline, 8-week
measure: Isometric Knee Extensor Force [OPTIONAL IN-PERSON VISIT]
timeFrame: baseline, 8-week
measure: Isometric Knee Flexor Force [OPTIONAL IN-PERSON VISIT]
timeFrame: baseline, 8-week
measure: Telehealth Usability Questionnaire
timeFrame: 8-week
measure: Weekly Log
timeFrame: Weekly for 14-weeks
measure: Heal Treatment Expectancy Survey - Short Form
timeFrame: baseline
measure: Treatment History
timeFrame: baseline, week 8, week 14
measure: eHealth Literacy Scale
timeFrame: baseline
Locations:
city: Boston
country: United States
facility: Movement and Applied Imaging Lab, Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Deepak Kumar, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: