Pain Informed Movement for People With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Pain Informed Movement for People With Knee Osteoarthritis: A Pilot and Feasibility Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730829
• Other study ID #: HiREB 15700
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2023
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: McMaster University
• Contact: Lisa Carlesso, PhD
• Phone: 289 426 2366
• Email: carlesl[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare a pain informed movement program to standard neuromuscular exercise in people with knee osteoarthritis. The main question it aims to answer are: 1. Are the two interventions a) pain informed movement program plus pain neuroscience education and b) neuromuscular exercise plus standard osteoarthritis education feasible in terms of recruitment, treatment adherence, timelines, data collection procedures, patient follow-up, and resources required? 2. Is there a difference in patient's satisfaction and acceptability of the two programs? 3. Are there any differences in the potential effects of the two programs on subjective pain measures, self-reported function, quality of life, functional leg strength, nervous system pain modulation, brain derived neurotrophic factor and nerve growth factor levels, and psychological factors?

Description:

It is critical to understand the underlying mechanism of knee osteoarthritis (OA) pain in order to effectively manage knee OA. It has become clear that alterations in central and peripheral nervous system functioning occurs in people with knee OA and pain sensitization is a common feature. Descending modulation from the central nervous system can facilitate or inhibit nociception. Endogenous pain modulation through the descending system is an important factor as its dysregulation has significant ramifications in pain facilitation and promotion of chronic pain development and maintenance at all levels of the nervous system. The current guidelines lack focus on how to effectively manage it, which is a potential reason for why the current methods in conservative management of knee OA pain are only moderately effective. Mind-body approaches are uniquely positioned to potentially reverse the sensitization, induce positive neuroplastic changes, and improve descending pain modulation resulting in decreased pain intensity in many chronic pain populations. This study involves an exercise program which the investigators call 'Pain Informed Movement' that includes evidence-based exercises combined with mind-body techniques and pain neuroscience education. The data from this phase will be used to inform a multi-site randomized controlled trial (RCT) to assess the program's effectiveness with the primary outcome of change in pain severity mediated by change in descending pain modulation. Exercise is regularly used as a first-line management option for knee OA, and its use is supported by high quality evidence to improve pain and function. Clinical practice guidelines for people with knee OA recommend the use of aerobic and strength training for the reduction of pain and improved physical function. Currently, one of the key components of conservative management of knee OA often implemented by clinicians is a type of exercise called neuromuscular exercise, which aims at improving sensorimotor control and the functionality of the knee joint by addressing movement in all three movement planes. Previous research has showed that the neuromuscular exercise programs designed specifically for knee OA can reduce pain, improve function, alter knee biomechanics, and improve the muscle-activation patterns of the surrounding knee musculature. While exercise is the first line treatment for knee OA and can lead to improvements in physical function and pain, it is important to highlight that it has a moderate effect, which may be short term. 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. Mind-body therapies can lead to pain reductions and improvement of function through various techniques. For instance, breathing exercises including breath awareness and regulation can activate the parasympathetic nervous system and decrease the danger signals of pain, leading to improvement of pain levels. Meditative breathing can lead to reductions in pain levels by modulating the somatosensory cortex. Relaxation techniques focused on relaxing the muscles that become tense as a result of pain and by association can re-enforce or aggravate pain, can influence the pain experience by reversing that association. Mindfulness meditation and mindful movement which can lead to a switch from sensory pain to the interoceptive awareness of the movements of the different body parts, resulting in reduced muscle tension, improvements in postural stability and proprioception, and reductions in pain levels. Mind-body therapies also lead to improvement of psychological factors such as depression, anxiety, pain catastrophizing, increasing pain acceptance, changing patients' relationships to their pain, which in turn lead to reductions in pain levels. The positive effects of mindfulness practices have been reported to last in longer-term follow ups such as 15 months, and 3 years. Education is another core component recommended by clinical guidelines and known to be effective particularly when combined with exercise. Pain Neuroscience education (PNE) is an alternative technique of teaching patients about pain and how to rethink and re-evaluate the way pain is viewed. The use of PNE in physical therapy interventions has been steadily increasing due to its positive effects on pain and function in many chronic pain patient populations. PNE includes an explanation of the neurophysiology of pain and its process by the nervous system. This includes how pain can be modulated through upregulation or downregulation of signals to increase or decrease the pain experience and that these changes are not necessarily related to tissue damage, particularly when pain becomes chronic. PNE also provides information regarding the influence of various psychosocial aspects. By offering avenues to reconceptualize pain as a threat to the body and movement as imminent danger, patients may become more willing to participate in physical activity and tolerate slight increases in pain and discomfort. In contrast standard OA education is the traditional and most widely used educational model in people with knee OA, focuses heavily on a pathoanatomical perspective of pain referring mainly to anatomy, biomechanics, and patho-anatomy of OA and the knee joint. Given the importance of finding effective management strategies for pain modulation in people with knee OA, there is a need to further our understanding of the impact of evidence-based exercise combined with mind-body techniques (e.g., breathing exercises and mindfulness) with PNE on pain mechanisms. The study is a pilot RCT with a nested qualitative component. The study will be guided by the Conceptual Framework for Defining Feasibility and Pilot studies and the Standard Protocol Items: Recommendations for Intervention Trials. Study Population A sample of 66 adults will be sought. The sample size is based on the primary outcome of complete follow-up using the confidence interval method for calculating sample size in pilot trials. 90% follow-up rate is the aim but the trial will be considered successful if 81% is achieved. To achieve a margin of error of 9%, with 10% added for attrition, 66 participants is required. Recruitment Participants will be recruited through the email lists of the McMaster Physical Activity Centre of Excellence (PACE) community and the McMaster Institute for Research on Aging (MIRA) newsletter. Postings will be placed on both PACE and MIRA social media pages. In addition, the study poster will be placed on other social media channels (i.e., Twitter, Facebook advertisements). In addition, flyers will be placed in local orthopaedic surgeon, Rheumatologist and Physiatrists offices. Physicians will provide potential participants with a one-page study information sheet in lay language. If interested, potential participants can then contact the research team through the contact information provided in the flyer. 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 or in one of two local community churches. 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 conditioned undergo pain modulation (CPM) and mechanical temporal summation testing, and the 30 Second Sit to Stand Test to determine leg strength and endurance. Lastly, participants will have their blood drawn (fasting) at the beginning and end of the study. Participants will then be asked to complete a series of questionnaires about their pain and mood. Interventions Twice weekly group exercise sessions will be 75 minutes for the intervention group and 60 minutes in duration for the control group. The intervention arm class is slightly longer due to the detailed delivery of instructions for the techniques during the class. Participants will be given instructions to complete these exercises at home at least one other time during the week for the same duration. Participants will receive education videos that are ~15-20 minutes each week, for up to 4 weeks. Pain Informed Movement and PNE - During the neuromuscular exercise sessions, the PNE components and concepts such as mindfulness, muscle tension regulation, and breathing techniques will be applied by the instructor. Neuromuscular exercise and standard OA education - The exercise component (i.e., the specific movements) of this group will be similar to those of the intervention group without the added mind-body techniques. Randomization and allocation concealment Participants will be randomized with an allocation ratio of 1:1 into one of two treatment groups (Pain informed movement and PNE versus neuromuscular exercise and standard OA education) using a REDCap randomization module. Following consent and completion of baseline assessment, the assessor (different person than the recruiter) will log in to the website, open the participants' identification record and click on the randomize button. Randomization will be blocked and this process will ensure allocation concealment. As allocation concealment occurs following the baseline assessment, the assessors will be blinded at baseline and follow up assessment. Blinding of instructors is generally not possible in studies of physical interventions (i.e., exercise). Participants will be blinded to study hypotheses and the two treatment groups. As both arms of the study are providing exercise based interventions and education, participants will be provided limited details of each intervention arm so as to blind them from knowing which is the intervention and which is the control. This will help minimize any bias that occurs by knowledge of group assignment and perception of treatment effects. Exit Survey and Focus Group In addition to the primary and secondary outcomes, 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• - =40 years of age with diagnosis of knee osteoarthritis (OA) by a physician OR;
• =45 years of age and having activity-related knee joint pain with or without morning stiffness lasting 30 minutes (NICE criteria)
• Having an average pain intensity of 3/10 on a numeric pain scale on most days of the past month

Exclusion Criteria:

• Cannot communicate in English;
• Has inflammatory arthritis or other systemic conditions;
• Have had lower limb trauma or surgery within the past 6 months;
• Have participated in a knee OA exercise program in the prior 3 months;
• Have had any injection in the index knee within 3-months prior to baseline assessment
• Does not have regular access to the internet
• Inability to get up and down from the floor independently
• Use of mobility aids
• Currently participating in any other drug/device/exercise clinical trial related to OA
• Planned absences (e.g., trips away) of >1 week
• Currently receiving other forms of care for knee OA pain (e.g., from a physiotherapist, chiropractor, athletic therapist, kinesiologist)
• Does not meet screening for safe participation in exercise according to the Get Active questionnaire from the Canadian Society for Exercise Physiology

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• pain informed movement
group classes twice weekly for 8 weeks of neuromuscular exercise in combination with mind-body techniques such as breath regulation, muscle tension regulation, relaxation, mindfulness, awareness of pain related thoughts and emotions.
• standard neuromuscular exercise
group classes twice weekly for 8 weeks of neuromuscular exercise.
• Pain Neuroscience Education (PNE)
The pain neuroscience education (PNE) will be delivered in videos addressing concepts such as the purpose of pain, neurophysiological changes of pain, movement guidelines when pain persists, and self-care techniques to impact neurophysiology and support moving with ease that include breath awareness and regulation, muscle tension regulation, awareness of pain related thoughts and emotions, relaxation, and body awareness.
• Standard osteoarthritis (OA) education
The standard osteoarthritis (OA) education will address the following topics, OA prevalence, risk factors, symptoms, diagnosis, treatment, role of exercise, surgery, self-management

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	Boston University, University of British Columbia, University of Melbourne

Country where clinical trial is conducted

Canada, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modified Charlson comorbidity index	to assesses the presence of comorbidities minimum score = 0, maximum = 20 with higher scores indicating greater severity.	baseline
Other	participant characteristics	Age, sex, gender, education, marital status, race, number of people living with, height	baseline
Other	Weight	Weight	baseline and 8 weeks
Other	Medication use	any medication that they take on a regular schedule	baseline and 8 weeks
Other	Perspectives on knee replacement surgery	Three questions will be asked: 1. Are your knee symptoms so severe that you wish to undergo knee replacement surgery? 2. Do you think knee replacement surgery is eventually inevitable? 3. In your opinion, what factor(s) can lead to better outcomes after knee replacement surgery?	baseline and 8 weeks
Other	Other painful body parts	Using a body diagram, participants will be asked to indicate any other areas where they experience pain	baseline and 8 weeks
Other	Mechanical Temporal Summation (TS)	to assess central sensitization using weighted probes. Pain rated after first stimulus and after 10th. TS calculated as difference from first to second.	baseline and 8 weeks
Other	Conditioned Pain modulation (CPM) measured with PPT test stimulus and conditioning stimulus of forearm ischemia	First stimulus of pressure pain threshold is delivered, next ischemic forearm test is conducted to a 4/10 and then PPT is repeated. 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 are no standard minimum or maximum values.	baseline and 8 weeks
Other	Pain intensity measured on the NRS	Three ratings: average pain intensity in the past 24 hours, past week, and worst pain in the past 24 hours will be recorded on a 0 1- numeric rating scale	baseline and 8 weeks
Other	Pain Catastrophizing Scale (PCS)	13 questions for a total score of 52 with higher scores indicating more severe symptoms. Minimum score = 0, maximum score 52	baseline and 8 weeks
Other	Self-Efficacy for Managing Chronic Disease 6-item scale (SEMCD-6)	measure of self-efficacy rated on 0-10 scale ranging from not at all confident to entirely confident	baseline and 8 weeks
Other	Hospital Anxiety and Depression Scale (HADS)	to assess anxiety and depression 7 questions each 0-3 with a total of 42	baseline and 8 weeks
Other	Brief Fear of Movement Scale for Osteoarthritis (BFMSO)	6 items to assess activity avoidance of participants due to pain-related fear of movement rated on a 4 point scale ranging from strongly disagree to strongly agree	baseline and 8 weeks
Other	Knee Injury and Osteoarthritis Outcome Score (KOOS)	to assess self-reported opinions about patients' knee and associated problems. Subscale of pain, activities of daily living and quality of life consisting of ratings of amount of pain and difficulty respectively from none to extreme. Scores are converted to out of 100 with higher scores indicating lower pain and higher function. Minimum scores are 0 and maximum scores are 20 and 68 for the pain and ADL subscales respectively.	baseline and 8 weeks
Other	Intermittent and Constant Osteoarthritis Pain (ICOAP) knee version	Intermittent and constant pain subscales 11 items scored from 0-4 totalling 44 and converted to a percentage out of 100.	baseline and 8 weeks
Other	30 Second Sit to Stand Test	to measure functional leg strength and endurance by counting the numbers of complete movements accomplished in the allotted time	baseline and 8 weeks
Other	serum levels of brain derived neurotrophic factors (BDNF) via blood analysis	a neurotrophin level measured in pg/ml	baseline and 8 weeks
Other	serum levels of nerve growth factor (NGF) via blood analysis	a neurotrophin level measured in pg/ml	baseline and 8 weeks
Other	perspectives on the effectiveness of the different intervention components on managing pain	One question will be asked of participants in each arm to rank the effectiveness of the different components of the intervention they received. e.g. "Please rank the different components of the intervention you received in order of how effective they are for managing your pain." A list of the different components in each study arm will be provided e.g. education videos, strengthening exercise, mind-body techniques	8 weeks
Primary	Percentage of follow up	percentage rate measured by those at baseline completing study follow up measures	8 weeks
Secondary	Usefulness of the program for managing knee OA measured on a 5 point Likert scale	Likert scale anchored from Not useful at all to very useful	8 weeks
Secondary	Usefulness of the education content measured on a 5 point Likert scale	Likert scale anchored from Not useful at all to very useful	8 weeks
Secondary	Frequency of the program measured on a 5 point Likert scale	Likert scale anchored from not frequent enough to Frequent enough	8 weeks
Secondary	frequency of the educational sessions measured on a 5 point Likert scale	Likert scale anchored from not frequent enough to Frequent enough	8 weeks
Secondary	Rate of recruitment measured by number of people recruited in a year	recruitment rate is a minimum of 40 people in a year	1 year
Secondary	burdensomeness of study procedures (questionnaires, tests, blood draws) measured on 0-10 scale	burdensomeness rating between 0 (no burden at all) to 10 (very much a burden)	8 weeks
Secondary	rate of adherence measured by percentage of sessions attended and home sessions completed	adherence rate calculated from attendance and exercise tracking sheets	8 weeks
Secondary	rate of adverse events measured by question regarding symptom flare and seeking treatment	measured as any problem that lasts for >2 days and/or causes the participant to seek other treatment	8 weeks