Pain Informed Movement for People With Knee Osteoarthritis

It is critical to understand the underlying mechanism of knee osteoarthritis (OA) pain inorder to effectively manage knee OA. It has become clear that alterations in central andperipheral nervous system functioning occurs in people with knee OA and painsensitization is a common feature. Descending modulation from the central nervous systemcan facilitate or inhibit nociception. Endogenous pain modulation through the descendingsystem is an important factor as its dysregulation has significant ramifications in painfacilitation and promotion of chronic pain development and maintenance at all levels ofthe 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 ofknee OA pain are only moderately effective. Mind‐body approaches are uniquely positionedto potentially reverse the sensitization, induce positive neuroplastic changes, andimprove descending pain modulation resulting in decreased pain intensity in many chronicpain populations. This study involves an exercise program which the investigators call'Pain Informed Movement' that includes evidence‐based exercises combined with mind‐bodytechniques and pain neuroscience education. The data from this phase will be used toinform a multi‐site randomized controlled trial (RCT) to assess the program'seffectiveness with the primary outcome of change in pain severity mediated by change indescending pain modulation.Exercise is regularly used as a first‐line management option for knee OA, and its use issupported by high quality evidence to improve pain and function. Clinical practiceguidelines for people with knee OA recommend the use of aerobic and strength training forthe reduction of pain and improved physical function. Currently, one of the keycomponents of conservative management of knee OA often implemented by clinicians is atype of exercise called neuromuscular exercise, which aims at improving sensorimotorcontrol and the functionality of the knee joint by addressing movement in all threemovement planes. Previous research has showed that the neuromuscular exercise programsdesigned specifically for knee OA can reduce pain, improve function, alter kneebiomechanics, and improve the muscle‐activation patterns of the surrounding kneemusculature. While exercise is the first line treatment for knee OA and can lead toimprovements in physical function and pain, it is important to highlight that it has amoderate effect, which may be short term.In recent years multiple guidelines for non‐surgical management of knee OA have begun toinclude mind‐body therapies, such as yoga or tai‐chi, as conditional or core treatmentrecommendations. Mind‐body therapies can lead to pain reductions and improvement offunction through various techniques. For instance, breathing exercises including breathawareness and regulation can activate the parasympathetic nervous system and decrease thedanger signals of pain, leading to improvement of pain levels. Meditative breathing canlead to reductions in pain levels by modulating the somatosensory cortex. Relaxationtechniques focused on relaxing the muscles that become tense as a result of pain and byassociation can re‐enforce or aggravate pain, can influence the pain experience byreversing that association. Mindfulness meditation and mindful movement which can lead toa switch from sensory pain to the interoceptive awareness of the movements of thedifferent body parts, resulting in reduced muscle tension, improvements in posturalstability and proprioception, and reductions in pain levels. Mind‐body therapies alsolead to improvement of psychological factors such as depression, anxiety, paincatastrophizing, increasing pain acceptance, changing patients' relationships to theirpain, which in turn lead to reductions in pain levels. The positive effects ofmindfulness practices have been reported to last in longer‐term follow ups such as 15months, and 3 years.Education is another core component recommended by clinical guidelines and known to beeffective particularly when combined with exercise. Pain Neuroscience education (PNE) isan alternative technique of teaching patients about pain and how to rethink andre‐evaluate the way pain is viewed. The use of PNE in physical therapy interventions hasbeen steadily increasing due to its positive effects on pain and function in many chronicpain patient populations. PNE includes an explanation of the neurophysiology of pain andits process by the nervous system. This includes how pain can be modulated throughupregulation or downregulation of signals to increase or decrease the pain experience andthat these changes are not necessarily related to tissue damage, particularly when painbecomes chronic. PNE also provides information regarding the influence of variouspsychosocial aspects. By offering avenues to reconceptualize pain as a threat to the bodyand movement as imminent danger, patients may become more willing to participate inphysical activity and tolerate slight increases in pain and discomfort.In contrast standard OA education is the traditional and most widely used educationalmodel in people with knee OA, focuses heavily on a pathoanatomical perspective of painreferring mainly to anatomy, biomechanics, and patho‐anatomy of OA and the knee joint.Given the importance of finding effective management strategies for pain modulation inpeople with knee OA, there is a need to further our understanding of the impact ofevidence‐based exercise combined with mind‐body techniques (e.g., breathing exercises andmindfulness) with PNE on pain mechanisms.The study is a pilot RCT with a nested qualitative component. The study will be guided bythe Conceptual Framework for Defining Feasibility and Pilot studies and the StandardProtocol Items: Recommendations for Intervention Trials.Study PopulationA sample of 66 adults will be sought. The sample size is based on the primary outcome ofcomplete follow‐up using the confidence interval method for calculating sample size inpilot trials. 90% follow‐up rate is the aim but the trial will be considered successfulif 81% is achieved. To achieve a margin of error of 9%, with 10% added for attrition, 66participants is required.Recruitment Participants will be recruited through the email lists of the McMasterPhysical Activity Centre of Excellence (PACE) community and the McMaster Institute forResearch on Aging (MIRA) newsletter. Postings will be placed on both PACE and MIRA socialmedia 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 localorthopaedic surgeon, Rheumatologist and Physiatrists offices. Physicians will providepotential participants with a one‐page study information sheet in lay language. Ifinterested, potential participants can then contact the research team through the contactinformation provided in the flyer.Setting The in‐person 8‐week exercise program will be held twice weekly at McMasterUniversity's Physical Activity Centre of Excellence (PACE) located in the Ivor‐WynneCentre or in one of two local community churches. Participants will complete the painassessment, 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 anassessment at the beginning of the study, and once again upon completing the 8‐weekexercise program. Participants will conditioned undergo pain modulation (CPM) andmechanical temporal summation testing, and the 30 Second Sit to Stand Test to determineleg strength and endurance. Lastly, participants will have their blood drawn (fasting) atthe beginning and end of the study. Participants will then be asked to complete a seriesof questionnaires about their pain and mood.Interventions Twice weekly group exercise sessions will be 75 minutes for theintervention group and 60 minutes in duration for the control group. The intervention armclass is slightly longer due to the detailed delivery of instructions for the techniquesduring the class. Participants will be given instructions to complete these exercises athome at least one other time during the week for the same duration. Participants willreceive 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 PNEcomponents and concepts such as mindfulness, muscle tension regulation, and breathingtechniques will be applied by the instructor.Neuromuscular exercise and standard OA education ‐ The exercise component (i.e., thespecific movements) of this group will be similar to those of the intervention groupwithout the added mind‐body techniques.Randomization and allocation concealment Participants will be randomized with anallocation ratio of 1:1 into one of two treatment groups (Pain informed movement and PNEversus neuromuscular exercise and standard OA education) using a REDCap randomizationmodule. Following consent and completion of baseline assessment, the assessor (differentperson than the recruiter) will log in to the website, open the participants'identification record and click on the randomize button. Randomization will be blockedand this process will ensure allocation concealment. As allocation concealment occursfollowing the baseline assessment, the assessors will be blinded at baseline and followup assessment. Blinding of instructors is generally not possible in studies of physicalinterventions (i.e., exercise). Participants will be blinded to study hypotheses and thetwo treatment groups. As both arms of the study are providing exercise basedinterventions and education, participants will be provided limited details of eachintervention arm so as to blind them from knowing which is the intervention and which isthe control. This will help minimize any bias that occurs by knowledge of groupassignment and perception of treatment effects.Exit Survey and Focus Group In addition to the primary and secondary outcomes, asatisfaction survey will be conducted at the end of the program to evaluate the a priorifeasibility criteria. Participants who indicated upon initially consenting to the studythat would like to participate in a focus group, will be contacted. Qualitative datacollection will be used to explore participants experience and perceptions of thefeasibility and acceptability of the program. A focus group will be conducted using audioor video recording (using Zoom), lasting between 45‐60 minutes.