Feasibility of Pain Informed Movement for Knee OA

Study Overview
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Brief Summary
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The pain experience and its associated mechanisms in people with knee osteoarthritis (OA) are known to be complex and multidimensional. The current understanding of OA pain mechanisms is incomplete, resulting in limited pain management strategies. There is high-quality evidence that suggests the use of exercise for people with knee OA can provide a reduction in pain, changes in quality of life, and have modest improvements in physical function. There is promising evidence to support that yoga for those with knee OA may improve pain intensity, function, and stiffness. The aim of this study is to establish the feasibility of a pain informed movement program, in addition to education for improving pain modulation. The data collected will be used to inform a pilot and feasibility randomized controlled trial (RCT) prior to a multi site RCT to assess the program's effectiveness with the primary outcome of change in pain severity mediated by change in descending modulation.

Detailed Description
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Background Exercise is regularly utilized as a first-line treatment for knee osteoarthritis, and its use is supported by high quality evidence to improve pain and function. Reductions in perceived pain can be explained in part by exercised-induced analgesia, which is thought to be mediated via numerous endogenous pathways. Furthermore, decreased nervous system sensitivity to noxious stimuli seem to play a role in the decreased pain experience of individuals who engage in exercise. These mechanisms likely play a role in improved function and reduced pain along with the improved balance, muscle strength and flexibility that are conventionally associated with exercise. In recent years multiple guidelines for non-surgical management of knee OA have begun to include mind-body therapies, such as yoga or tai-chi, as conditional or core treatment recommendations. Structured yoga programs have been shown to result in decreased pain and improved function when compared to no exercise and conventional exercise. BDNF is a neurotrophin that appears to play an important role in the central modulation of pain in adults, and altered expression of BDNF is likely to play an important role in the pathophysiology of chronic pain. Individuals with knee OA have been shown to possess altered levels of serum BDNF compared to healthy controls, indicating that BDNF may be implicated in the pain-experience of patients with knee OA. Thus, BDNF has been identified as a therapeutic target in the treatment of pain resulting from central sensitization. NGF is a neurotrophin known to play a critical role in the proper development of the nervous system. Evidence indicates that NGF is also involved in the increased pain experience of many individuals via peripheral sensitization of nociceptive neurons. Therefore, NGF levels have been shown to be elevated in a wide variety of chronic pain conditions including knee OA. Anti-NGF therapies are being highly studied as they have significant potential to decrease pain and improve function in individuals with OA that do not respond to conventional analgesics. Objectives The aim of this study is to establish the feasibility of a pain informed movement program, in addition to education for improving pain modulation. The data collected will be used to inform a pilot and feasibility randomized controlled trial (RCT) prior to a multi site RCT to assess the program's effectiveness with the primary outcome of descending modulation as a mediator of change in pain severity. Research questions Is the pain informed movement and education program feasible in terms of recruitment rate, treatment adherence, timelines, data collection procedures, patient follow-up and resources required? Is the pain informed movement and education program feasible in terms of patient's satisfaction and acceptability? Study Population A convenience sample of 15 adults will be sought and is adequate to evaluate the feasibility of the program. Recruitment Participants will be recruited through the email lists of the McMaster Physical Activity Centre of Excellence (PACE) community. Recruitment posters will also be included in the McMaster Institute for Research on Aging (MIRA) newsletter. In addition, we will place postings on both PACE and MIRA social media pages. Setting The in-person 8-week exercise program will be held twice weekly at McMaster University's Physical Activity Centre of Excellence (PACE) located in the Ivor-Wynne Centre. Participants will complete the pain assessment, and have blood drawn at PACE by PACE staff who are certified phlebotomists. Assessment As part of participation in the study, participants will be asked to attend an assessment at the beginning of the study, and once again upon completing the 8-week exercise program. Participants will undergo pain modulation (CPM) testing, and the 30 Second Sit to Stand Test to determine leg strength and endurance. Lastly, participants will have their blood drawn at the beginning and end of the study. Participants will then be asked to complete a series of questionnaires about their pain and mood. Exit Survey and Focus Group A satisfaction survey will be conducted at the end of the program to evaluate the a priori feasibility criteria. Participants who indicated upon initially consenting to the study that they would like to participate in a focus group, will be contacted. Qualitative data collection will be used to explore participants experience and perceptions of the feasibility and acceptability of the program. A focus group will be conducted using audio or video recording (using Zoom), lasting between 45-60 minutes.

Official Title
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Feasibility of Pain Informed Movement for People With Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Pain Informed Movement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40 years of age and over Have a diagnosis of knee OA by a physician or fulfill the NICE criteria for knee OA diagnosis Have an average pain intensity of ≥3/10 on a numeric pain scale Exclusion Criteria: Cannot communicate in English Have inflammatory arthritis or other systemic conditions Have had lower limb trauma Had surgery within the past 6-month, have participated in a similar knee OA exercise program in the prior 3-months Have used oral corticosteroids or had a corticosteroid injection in the index knee within 6-months prior to baseline assessment. Does not have access to the internet

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Informed Movement<br>This will be an 8-week in-person group exercise program held twice weekly, in which participants will receive pain Informed movement (60 minutes), with instructions provided for a third home session. Home sessions will be facilitated by exercise handout sheets. Pain education will be delivered through weekly access to videos. The pain informed movement component has been developed by a team member and will be delivered by an experienced yoga teacher. | Other: Pain Informed Movement<br>* Participants will attend a twice weekly exercise program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Content | A Likert scale out of 5 will assess how useful participants found the treatment. | 8 weeks | 
| Acceptability of Frequency | A Likert scale out of 5 will assess how acceptable participants found the frequency of the treatment. | 8 weeks | 
| Acceptability of Duration | A Likert scale out of 5 will assess how acceptable participants found the duration of the treatment. | 8 weeks | 
| Burden of questionnaires | A numeric rating scale out of 10 will assess how burdensome participants found completing the questionnaires, with 1 representing not at all a burden and 10 representing very much a burden. | 8 weeks | 
| Burden of physical tests | A numeric rating scale out of 10 will assess how burdensome participants found completing the physical tests, with 1 representing not at all a burden and 10 representing very much a burden. | 8 weeks | 
| Recruitment Rate | Percentage of eligible participants who consent to participate. | 8 weeks | 
| Adherence Rate | Percentage of participants who attend all in person treatment sessions. | 8 weeks | 
| Follow-Up Rate | Percentage of participants who follow-up at 8 weeks. | 8 weeks | 
| Self Reported Adverse Events | Percentage of participants who did not experience any adverse events or only mild transient. | 8 weeks | 
| Exercise Completion | Percentage of participants who report exercising at least 3 times a week. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Modulation | Pain modulation will be assessed through conditioned pain modulation. First an ascending measure of pressure pain threshold (PPT) inducing a verbal pain rating of 3 out of 10 will be evaluated at the anterior shin on the unaffected knee. Next a conditioning stimulus in the form of forearm ischemia will be applied to induce a minimum verbal pain rating of 5 out of 10 at the opposite volar forearm. The arm will be elevated to chest level with a blood pressure cuff around the middle of the upper arm. Systolic pressure will be determined. Next the cuff will be inflated to 20mmhg above systolic pressure and the participant will be asked to squeeze a stress ball until a pain rating of 5/10 is reported. Once pain rating is recorded, PPT at the anterior shin will be repeated as the cuff remains inflated. An index will be created by calculating the percent efficiency of CPM (%CPM) as PPT2/PPT1, multiplied by 100; whereby %CPM ≤ 100 indicates inefficient pain modulation CPM. | 8 weeks | 
| Change in Pain Intensity | Pain intensity will be measured using the numeric rating scale. The average of three questions will be used: average pain intensity in the past 24 hours, past week, and worst pain in the past 24 hours. Questions are rated on a an 11-point scale where patients select a rating between 0-10 with zero typically represents 'no pain' while 10 represents the 'worst imaginable pain. | 8 weeks | 
| Change in Function | Function will be measured using the Knee Injury and Osteoarthritis Outcome Score. The Knee Injury and Osteoarthritis Outcome Score has 42 items in 5 scored sub scales, of which two will be used: 1) pain, and 2) function in daily living (ADL). Scores range from 0-100 with zero representing extreme knee problems and 100 representing no knee problems. | 8 weeks | 
| Change in Brain-derived neurotrophic factor | Brain-derived neurotrophic factor is a neurotrophin that appears to play a role in the central modulation of pain and pathophysiology of chronic pain. Blood will be drawn for analysis of brain-derived neurotrophic factor reported in ng/ml. | 8 weeks | 
| Change in Nerve growth factor | Nerve growth factor is a neurotrophin that plays a role in the proper development of the nervous system and is involved in the increased pain experience of many individuals via peripheral sensitization of nociceptive neurons. Blood will be drawn for analysis of nerve growth factor reported in pg/ml. | 8 weeks | 
| Change in Pain catastrophizing | Pain catastrophizing scale will be measuring pain catastrophizing. It is a 13-item self reporting instrument, with higher scores indicating higher pain catastrophizing. Sub-scores for 3 dimensions will be used - rumination, magnification, and helplessness. | 8 weeks | 
| Change in Chronic pain self-efficacy | Self-Efficacy for Managing Chronic Disease is a 6-item scale with higher scores indicating higher self-efficacy. | 8 weeks | 
| Change in Physical performance tests | The 30 Second Sit to Stand Test will be used to test leg strength and endurance. The maximum number of chair stand repetitions completed during a 30 second interval will be noted along with use of any aids during testing. | 8 weeks | 
| Change in anxiety and depression | Hospital Anxiety and Depression Scale consists of 7 questions to measure anxiety and 7 questions to measure depression. Higher scores represent increased severity in anxiety and depression symptoms. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain Management, Pain Modulation, Yoga, Knee Osteoarthritis