Telehealth Exercise and Mindfulness for Pain in Osteoarthritis

Knee Osteoarthritis Clinical Trial

— TEMPO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05524116
• Other study ID #: 56789
• Secondary ID: 6492E
• Status: Completed
• Phase: N/A
• Start date: October 4, 2022
• Est. completion date: July 3, 2023

Study information

• Verified date: July 2023
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 3, 2023
• Est. primary completion date: May 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis

Intervention

Behavioral:
• Mindful Exercise program
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
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.

Locations

Country	Name	City	State
United States	Movement and Applied Imaging Lab, Boston University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Proportion of participants that are recruited for the study	through the recruitment process, up to 6 months from the start of the study
Primary	Attendance	Proportion of participants that attended the intervention sessions	post-intervention (at 12-weeks)
Primary	Retention Rate	Proportion of participants who complete patient-reported outcome surveys	post-intervention visit (at the end of 12-weeks)
Secondary	Knee Injury and Osteoarthritis Outcome Score	Patient-reported outcome for knee pain and disability; a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.	baseline, 8-week, 14-week
Secondary	Pain, Enjoyment, General Activity scale	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.	baseline, 8-week, 14-week
Secondary	Numeric Rating Scale - nominated activity	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	baseline, 8-week, 14-week
Secondary	Participant global impression of change	participant's rating of change in condition on a 7-point scale. Higher scores represent improvement and lower scores represent worsening or no change in symptoms	8-week, 14-week
Secondary	Patient Global Assessment of Osteoarthritis	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	baseline, 8-week, 14-week
Secondary	Pain Catastrophizing	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).	baseline, 8-week
Secondary	Widespread Pain Index Symptom Severity Scale	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.	baseline, 8-week
Secondary	Pain DETECT	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	baseline, 8-week
Secondary	Patient Health Questionnaire 8-item	questionnaire assessing depression symptoms. each question is scored from 0 to 3 where higher scores indicate higher frequency of experiencing depressive symptoms. the sum value of individual questions is the total score. Higher total scores indicate greater severity of depression	baseline, 8-week, 14-week
Secondary	Cognitive and Affective Mindfulness Scale - Revised	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.	baseline, 8-week, 14-week
Secondary	eHealth Literacy Scale	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	baseline
Secondary	Arthritis - Rapid Estimate of Adult Literacy in Medicine (A-REALM)	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	baseline
Secondary	Fear Avoidance Beliefs Questionnaire - Physical Activity	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. Higher total scores indicate greater fear of physical activity	baseline, 8-week
Secondary	Arthritis Self Efficacy Scale	confidence in one's capacity to function despite pain. Scores range from 10 (very uncertain) to 100 (very certain). Higher scores indicate greater self-efficacy to manage osteoarthritis.	baseline, 8-week
Secondary	Chronic pain self-efficacy questionnaire	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). higher total scores indicate greater self-efficacy to manage one's chronic pain.	baseline, 8-week
Secondary	Telehealth Usability Questionnaire	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	8-week
Secondary	Satisfaction Scale	custom 4-item (0-10 likert scale) to determine satisfaction with individual components of the intervention	8-week
Secondary	Sit to stand test [OPTIONAL IN-PERSON VISIT]	functional test that measures the time taken to sit and stand from chair five times	baseline, 8-week
Secondary	6-minute walk test [OPTIONAL IN-PERSON VISIT]	functional test that measures the maximal distance covered while walking at fast-pace for six minutes	baseline, 8-week
Secondary	7-meter walk test [OPTIONAL IN-PERSON VISIT]	functional test that measures comfortable walking speed as participant walks back and forth over 7 meters twice	baseline, 8-week
Secondary	Stair climb test [OPTIONAL IN-PERSON VISIT]	functional test that measures the time taken to ascend and descend a flight of stairs	baseline, 8-week
Secondary	Pressure Pain Threshold [OPTIONAL IN-PERSON VISIT]	a test of pain sensitivity	baseline, 8-week
Secondary	Mechanical Temporal Summation [OPTIONAL IN-PERSON VISIT]	a test of central pain sensitization	baseline, 8-week
Secondary	Conditioned Pain Modulation [OPTIONAL IN-PERSON VISIT]	a test of descending pain modulation	baseline, 8-week
Secondary	Exercise Induced Hypoalgesia [OPTIONAL IN-PERSON VISIT]	a test of change in pain sensitivity after a bout of exercise	baseline, 8-week
Secondary	Isometric knee extensor force [OPTIONAL IN-PERSON VISIT]	knee extensor isometric muscle strength	baseline, 8-week
Secondary	Isometric knee flexor force [OPTIONAL IN-PERSON VISIT]	knee flexor isometric muscle strength	baseline, 8-week
Secondary	Individual Interviews with 20 participants [ONLY FOR SELECT PARTICIPANTS]	interviews to explore acceptability of the mindful exercise intervention	8-week
Secondary	Participant feedback survey	feedback on the intervention and interventionists	8-week
Secondary	Weekly exercise log	log of exercise and aerobic activity	Weekly for 14-weeks
Secondary	Weekly mindful exercise log	log of mindfulness practice	weekly for 14 weeks
Secondary	Heal Treatment Expectancy Survey - short form	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	baseline
Secondary	Demographics	a survey that collects information to help understand the background characteristics of the individual such as race, ethnicity, education, employment status, and family income	baseline
Secondary	Comorbidities	a survey that collects information on presence of other medical health conditions including heart disease, diabetes, etc.	baseline
Secondary	Treatment History	a survey that collects information about the treatments the individual has undertaken for their knee osteoarthritis	baseline
Secondary	Phenx Access Health Technology Survey	a survey that collects information about access the individual has to health technology	baseline