Feasibility of Pain Informed Movement for Knee OA

Not Applicable

Completed

Conditions: Knee Osteoarthritis

Interventions: Other: Pain Informed Movement

Registration Number: NCT04954586

Lead Sponsor: McMaster University

Brief Summary: 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: 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

1. 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?

2. 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.

Statistical Analysis Plan (SAP)

All quantitative analyses will be conducted using SPSS 26. Descriptive statistics will be used to report feasibility outcomes, and survey responses will be summarized (using descriptive statistics) to identify trends in patient-reported outcomes. Qualitative interviews will be analyzed using Thematic content analysis to identify suggestions for program modification. Line-by-line reading of the transcripts will be performed by the authors and thematic patterns will be explored. Once themes and patterns are identified, each meaningful segment of text will be assigned a conceptual code. When conceptual codes become saturated, authors will build pattern codes where specific dimensions of clinicians' experiences will be clustered into recurring themes. Once the codes and themes are developed, participant and clinician partners will be invited to contribute to blinded data analysis to broaden interpretations and provide feedback on the quotes and emergent themes.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 19

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pain Informed Movement	Pain Informed Movement	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.

Primary Outcome Measures

Name	Time	Method
Acceptability of Content	8 weeks	A Likert scale out of 5 will assess how useful participants found the treatment. The minimum value is 1 and the maximum value is 5, with higher scores indicating a better outcome. The count of participants that reported the acceptability of content \>4/5 is reported and considered for proceeding with the study without protocol amendment.
Acceptability of Frequency	8 weeks	A Likert scale out of 5 will assess how acceptable participants found the frequency of the treatment. The minimum value is 1 and the maximum value is 5, with higher scores indicating a better outcome. The count of participants that reported the acceptability of frequency \>4/5 is reported and considered for proceeding with the study without protocol amendment.
Acceptability of Duration	8 weeks	A Likert scale out of 5 will assess how acceptable participants found the duration of the treatment. The minimum value is 1 and the maximum value is 5, with higher scores indicating a better outcome. The count of participants that reported the acceptability of duration \>4/5 is reported and considered for proceeding with the study without protocol amendment.
Burden of Questionnaires	8 weeks	A numeric rating scale out of 10 will assess how burdensome participants found completing the questionnaires. On this scale,1 represents no burden at all and 10 represents very much a burden. Higher scores indicate a worse outcome. There is no minimum or maximum value. The count of participants that reported the burden \<3/10 is reported and considered for proceeding with the study without protocol amendment
Burden of Physical Tests	8 weeks	A numeric rating scale out of 10 will assess how burdensome participants found completing the physical tests. On this scale,1 represents no burden at all and 10 represents very much a burden. Higher scores indicate a worse outcome. The count of participants that reported the burden \<3/10 is reported and considered for proceeding with the study without protocol amendment.
Recruitment Rate	8 weeks	Number of eligible participants who consent to participate in 1 month.
Follow-Up Rate	8 weeks	Percentage of participants who follow-up at 8 weeks.
Self Reported Adverse Events	8 weeks	Percentage of participants who did not experience any adverse events or only mild transient.
Exercise Completion	8 weeks	Percentage of participants who report exercising at least 3 times a week.
Adherence	8 weeks	Adherence to the program. This is the number of sessions that were attended by the participants. There are 2 sessions per week for 8 weeks, for a total of 16 sessions per participants. With 14 participants being in the study, the total number of sessions to be attended is 224. The number of sessions that were actually attended is being reported.
Recommending the Program	8 weeks	Likelihood of recommending the program to others. On a scale of 1 to 5, participants rate how likely they would recommend the program to other people. On this scale, 1 is the minimum, and 5 is the maximum, with higher scores indicating a better outcome. Participants that indicate a score of 4 or 5 are counted as the number of participants that would likely recommend the program to others (the number being reported).
Using the Treatment Again	8 weeks	Likelihood of using the treatment again. On a scale of 1 to 5, participants rate how likely they would use the treatment again. On this scale, 1 is the minimum, and 5 is the maximum, with higher scores indicating a better outcome. Participants that indicate a score of 4 or 5 are counted as the number of participants that would likely use it again (the number being reported).

Secondary Outcome Measures

Name	Time	Method
Change in Function	8 weeks	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. Higher scores mean a better outcome. A change between two time points (baseline and 8 weeks) is reported.
Change in Brain-derived Neurotrophic Factor	8 weeks	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. There is no minimum or maximum values. A change between two time points (baseline and 8 weeks) is reported.
Change in Pain Modulation	Baseline, 8 weeks	Pain modulation is assessed through conditioned pain modulation (CPM). First an ascending measure of pressure pain threshold (PPT) inducing a pain rating of 3/10 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 5/10 at the opposite volar forearm. Systolic pressure will be determined. 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. There is no minimum or maximum value. A change between two time points (baseline and 8 weeks) is reported.
Change in Pain Intensity - Past 24 Hours	Baseline, 8 weeks	Pain intensity will be measured using the numeric rating scale. Questions are rated on a an 11-point scale where patients select a rating between 0 and 10 with zero representing 'no pain' while 10 represents the 'worst imaginable pain. Higher scores mean a worse outcome. A change between two time points (baseline and 8 weeks) is reported.
Change in Pain Catastrophizing	8 weeks	Pain catastrophizing scale will be measuring pain catastrophizing. It is a 13-item self reporting instrument. Each item on the scale is rated on a 5-point scale, ranging from 0 (not at all) to 4 (all the time). The total score on the PCS is the sum of the ratings for all 13 items, ranging from 0 to 52, with higher scores indicating higher pain catastrophizing (worse outcome). Subscales are combined to get the total score. Sub-scores for 3 dimensions will be used - rumination (range 0 to 12), magnification (range 0 to 12), and helplessness (range 0 to 28). A change between two time points (baseline and 8 weeks) is reported.
Change in Chronic Pain Self-efficacy	8 weeks	Self-Efficacy for Managing Chronic Disease is a 6-item scale. The minimum value on each item is 1 and the maximum value on each item is 10. The score for the scale is the mean of the six items. The range for the total score is 1 to 10, with higher scores indicating higher self-efficacy and mean a better outcome. A change between two time points (baseline and 8 weeks) is reported.
Change in Physical Performance Tests	8 weeks	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. A change between two time points (baseline and 8 weeks) is reported.
Change in Anxiety and Depression	8 weeks	Hospital Anxiety and Depression Scale consists of 7 questions to measure anxiety and 7 questions to measure depression. The minimum value on each item is 0 and the maximum value on each item is 3. The total score range is 0 to 21 for each subscale and higher scores represent increased severity in anxiety and depression symptoms (worse outcome). A total score can be created by combining the two subscales and the range would be from 0 to 42. A change between two time points (baseline and 8 weeks) is reported.
Change in Perspectives on Knee Replacement Surgery 1	8 weeks	The question being asked is: Are your knee symptoms so severe that you wish to undergo knee replacement surgery? Answer options are yes, no, or unsure. There is no minimum, maximum, or total score. Count of participants that report Yes are reported.
Change in Perspectives on Knee Replacement Surgery 2	8 weeks	The question being asked is: Do you think knee replacement surgery is eventually inevitable? Answer options are yes or no. There is no minimum, maximum, or total score. Count of participants that report Yes are reported.
Change in Perspectives on Knee Replacement Surgery 3	8 weeks	The question being asked is: In your opinion, what factor(s) can lead to better outcomes after knee replacement surgery? Participants are given the following options to choose from: Good surgeon, healthy weight, good overall health, good social support, good mental health, less pain and disability before the surgery due to regular exercise, good hospital, not working (including house work), using pain killers after the surgery. Count of participants that do not choose 'less pain and disability before the surgery due to regular exercise' is reported.
Change in Pain	8 weeks	Pain will also 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 (better outcome). A change between two time points (baseline and 8 weeks) is reported.