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Completed

NCT Number: NCT05524116

Telehealth Exercise and Mindfulness for Pain in Osteoarthritis

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Movement and Applied Imaging Lab, Boston University

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindful Exercise program

Behavioral

In this 8-week intervention, components of Mindful Based Stress Reduction Program will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis. The goal of this program is to train participants how to be mindful during their exercises.

Exercise

Behavioral

In this 8-week intervention, participants will be given recommended strengthening and neuromuscular exercises for knee osteoarthritis. Participants in both the intervention and control group will receive these exercises.

Primary outcomes

  1. Recruitment

    Time frame: through the recruitment process, up to 6 months from the start of the study

    Number of participants that are randomized for the study

  2. Attendance

    Time frame: post-intervention (at 8-weeks)

    Proportion of sessions attended

  3. Retention Rate

    Time frame: post-intervention visit (at the end of 8-weeks)

    Proportion of participants who complete patient-reported outcome surveys

  4. Participant Feedback Survey

    Time frame: 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)

  5. Satisfaction Scale

    Time frame: 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 outcomes

  1. Knee Injury and Osteoarthritis Outcome Score

    Time frame: 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.

  2. Pain, Enjoyment, General Activity Scale

    Time frame: 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.

  3. Numeric Rating Scale - Nominated Activity

    Time frame: 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

  4. Participant Global Impression of Change

    Time frame: 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.

  5. Patient Global Assessment of Osteoarthritis

    Time frame: 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

  6. Pain Catastrophizing Scale

    Time frame: 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).

  7. Widespread Pain Index Symptom Severity Scale

    Time frame: 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.

  8. Pain DETECT

    Time frame: 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

  9. Patient Health Questionnaire 8-item

    Time frame: 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

  10. Cognitive and Affective Mindfulness Scale - Revised

    Time frame: 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.

  11. Fear Avoidance Beliefs Questionnaire - Physical Activity

    Time frame: 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

  12. Arthritis Self Efficacy Scale

    Time frame: 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.

  13. Chronic Pain Self-efficacy Questionnaire

    Time frame: 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.

Other outcomes

  1. Arthritis - Rapid Estimate of Adult Literacy in Medicine (A-REALM)

    Time frame: baseline

    66-word recognition adult health literacy test. Each correct pronunciation of word is scored as 1. The total score is classified into 1 to 4 reading grade levels where higher scores (61-66) represent ninth grade and above reading level

  2. Sit to Stand Test [OPTIONAL IN-PERSON VISIT]

    Time frame: baseline, 8-week

    functional test that measures the time taken to sit and stand from chair five times

  3. 6-minute Walk Test [OPTIONAL IN-PERSON VISIT]

    Time frame: baseline, 8-week

    functional test that measures the maximal distance covered while walking at fast-pace for six minutes

  4. 7-meter Walk Test [OPTIONAL IN-PERSON VISIT]

    Time frame: baseline, 8-week

    functional test that measures comfortable walking speed as participant walks back and forth over 7 meters twice

  5. Stair Climb Test [OPTIONAL IN-PERSON VISIT]

    Time frame: baseline, 8-week

    functional test that measures the time taken to ascend and descend a flight of stairs

  6. Pressure Pain Threshold [OPTIONAL IN-PERSON VISIT]

    Time frame: baseline, 8-week

    a test of pain sensitivity

  7. Mechanical Temporal Summation [OPTIONAL IN-PERSON VISIT]

    Time frame: baseline, 8-week

    a test of central pain sensitization

  8. Conditioned Pain Modulation [OPTIONAL IN-PERSON VISIT]

    Time frame: baseline, 8-week

    a test of descending pain modulation

  9. Exercise Induced Hypoalgesia [OPTIONAL IN-PERSON VISIT]

    Time frame: baseline, 8-week

    a test of change in pain sensitivity after a bout of exercise

  10. Isometric Knee Extensor Force [OPTIONAL IN-PERSON VISIT]

    Time frame: baseline, 8-week

    knee extensor isometric muscle strength

  11. Isometric Knee Flexor Force [OPTIONAL IN-PERSON VISIT]

    Time frame: baseline, 8-week

    knee flexor isometric muscle strength

  12. Telehealth Usability Questionnaire

    Time frame: 8-week

    scale evaluating the usability and satisfaction of telehealth implementation and services. Each item is rated on a seven-point Likert scale, with a rating of one indicating disagree and a rating of seven indicating agree; higher ratings indicate better system usability

  13. Weekly Log

    Time frame: Weekly for 14-weeks

    log of minutes and days spent doing strengthening exercises, aerobic exercises, and mindfulness practice (mindfulness practice only applicable to people in the TMX group). Survey also includes log of oral analgesic use.

  14. Heal Treatment Expectancy Survey - Short Form

    Time frame: baseline

    6-item survey assessing participant's attitude and expectations of the intervention measured on a 5-point likert scale. higher scores indicate more positive attitude and expectations for the treatment

  15. Treatment History

    Time frame: baseline, week 8, week 14

    a survey that collects information about the treatments the individual has undertaken for their knee osteoarthritis

  16. eHealth Literacy Scale

    Time frame: baseline

    8-item scale measuring one's perceived ability and comfort with accessing digital services for health information. each item is rated on a 5-point likert scale. total scores are summed. higher scores indicate greater perceived skills at using online health information to help solve health problems

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Registry information

Official study title

Telehealth Exercise and Mindfulness for Pain in Osteoarthritis: A Feasibility Study

Acronym: TEMPO

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2022
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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