Clinical trial NCT06400329: Physiological Impact of Different Types of Osteoarthritis Education.
Official title: Evaluating the Physiological Impact of Pain Neuroscience Education Versus Standard Education for Older Adults With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Chronic Pain
Keywords: Pain Neuroscience Education (PNE)
Osteoarthritis
Autonomic Nervous System (ANS)
Physiological responses
Biomedical education
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 37
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators are comparing two types of education for older adults with knee osteoarthritis: standard biomedical education focusing on the disease process, and a newer approach called pain neuroscience education (PNE), which teaches about the complexity of pain and dispels myths. While PNE has shown benefits in self-reported pain and function, little is known about its effects on physiological responses to pain.

the investigators will measure physiological indicators, particularly activity in the autonomic nervous system (ANS), which is closely linked to pain. Dysregulation in the ANS is common in chronic pain conditions like osteoarthritis. Our study aims to assess the feasibility of comparing these education methods and explore differences in physiological responses, as well as self-reported outcomes like cognitive and emotional factors.

Our goals are to determine if the study protocol is feasible, assess participants' acceptance of the assessment procedures, and explore differences in physiological markers and self-reported outcomes between the two education groups. Ultimately, the investigators aim to understand how different educational approaches may affect nervous system processing in older adults with knee osteoarthritis. the investigators hypothesize that those receiving PNE will show less autonomic arousal and nervous system sensitivity compared to those receiving standard education.

Detailed description: Education and understanding of musculoskeletal (MSK) pain is known to be important for individuals and can improve patient outcomes (i.e. pain and function)(1). Many years ago, it became apparent that there was a vast disconnect between the scientific understanding of pain (i.e. its protective function, its complexity, and the most effective ways of treating it) and the current understanding of 'how pain works' held by patients and health professionals alike(2), one that was entrenched in an outdated biomedical model. Traditionally education has focused on the disease process which can have a negative impact with its language and images due to its focus on structural pathology.(3) Additionally, despite the known benefits of certain interventions e.g. exercise for MSK disorders, people may be wrongly advised that too much exercise could cause joint pain and damage.(4) Many of these poorly construed messages are due to a lack of understanding of the impact of such language, the complexity of the pain experience, and its lack of correlation with what the investigators now consider to be normal age-related changes seen on imaging.(2) The aim of intensive education about pain neuroscience was to give credibility to the best treatments available - active, psychological and self-management skills by providing a modern understanding of how pain works with the hope of giving power and agency to individuals to make optimal decisions about how to manage their health situation. Simply put, PNE aimed to enable and empower patients to adopt a biopsychosocial understanding of their problem and thereby pursue a biopsychosocial-based approach to overcoming it.(2) PNE involves the process of educating individuals about the complexity of pain and how our bodies process pain. It also seeks to dispel many of the myths long held by the public regarding MSK disorders(5). Despite PNE showing consistent positive effects on self-reported pain and function, there has been a growing debate in the literature regarding its value(6,7) Interestingly, there has been little to no evaluation of how differing approaches to education impacts people's physiological reactions and nervous system processing of pain. This project will fill that gap by providing unique understanding of how the type of educational content provided to older adults with knee osteoarthritis may impact their nervous system functioning and processing of pain.

Measuring pain remains a challenge, especially from a psycho-physiological aspect(8). Among various physiological indicators, the activity of the autonomic nervous system (ANS), specifically its sympathetic and parasympathetic subdivisions, is closely associated with pain (9). Enhanced activity in the sympathetic nervous system leads to increased electrodermal activity (sweating), respiration rate, heart rate, blood pressure, vascular vasoconstriction, and pupil dilation. In states of chronic pain, the autonomic nervous system may experience dysregulation, often resulting in diminished autonomic responsiveness to painful or stressful stimuli. Autonomic dysfunction has been observed in various chronic conditions, including knee osteoarthritis(10), low back pain(9), rheumatoid arthritis(11), and fibromyalgia(12). Targeting the dysregulated autonomic nervous system could potentially restore balance to stress response systems and alleviate systemic inflammation. The purpose of this pilot study will be to evaluate 1) the feasibility of a study protocol to investigate if there are differences in physiological responses associated with exposure to different types of knee osteoarthritis educational content. 2) to explore differences in the physiological responses between exposure to pain neuroscience education and standard biomedical education and 3) to explore differences in self-reported cognitive, emotional and functional outcomes and the physiological responses in each intervention arm

Eligibility criteria: Inclusion Criteria:

* ≥ 55-85years old
* community dwelling adults with a diagnosis of knee osteoarthritis or fulfilling the NICE criteria for knee OA
* activity-related joint pain
* either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes

Exclusion Criteria:

* those who have received prior PNE
* those who have eye glasses prescription exceeding +/- 6 for spherical correction and/or +3 for astigmatism

Primary outcomes:
measure: Burden of the assessments
timeFrame: 1 week post-intervention
measure: feasibility outcomes (recruitment rate)
timeFrame: at 3 months
measure: Feasibility outcomes (Educational content and format acceptability)
timeFrame: 1 week post-intervention
measure: Feasibility outcomes (Lab Site accessibility/ Participant Convenience)
timeFrame: 1 week post-intervention
measure: Feasibility outcomes (Scheduling of Lab assessments)
timeFrame: 1 week post-intervention
Secondary outcomes:
measure: Demographic information
timeFrame: At baseline
measure: Temporal Summation (TS)
timeFrame: Before and after the delivery of the intervention
measure: Eye Tracker
timeFrame: During the delivery of the intervention
measure: Galvanic Skin Response
timeFrame: Before and during the delivery of the intervention
measure: Heart Rate variability
timeFrame: Before and during delivery of the intervention
measure: Respiratory Rate
timeFrame: Before and during delivery of the intervention
measure: Chronic pain self-efficacy
timeFrame: Before and after the delivery of the intervention
measure: Anxiety symptoms
timeFrame: Before and after the delivery of the intervention
measure: Fear of movement
timeFrame: Before and after the delivery of the intervention
measure: Knee injury and outcomes
timeFrame: Before and after the delivery of the intervention
measure: eHEALS
timeFrame: Before the delivery of the intervention
measure: The Osteoarthritis Conceptualization Questionnaire
timeFrame: Before and after the delivery of the intervention
measure: The Intention to Exercise scale
timeFrame: Before and after the delivery of the intervention
measure: The surgery intention scale
timeFrame: Before and after the delivery of the intervention
measure: The Self-Administered Comorbidity Questionnaire (SCQ)
timeFrame: Before the delivery of the intervention
measure: Satisfaction with Information Quality
timeFrame: After the delivery of the intervention
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Lisa Carlesso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
citation: Moseley L. Unraveling the barriers to reconceptualization of the problem in chronic pain: the actual and perceived ability of patients and health professionals to understand the neurophysiology. J Pain. 2003 May;4(4):184-9. doi: 10.1016/s1526-5900(03)00488-7.
citation: Domenech J, Sanchez-Zuriaga D, Segura-Orti E, Espejo-Tort B, Lison JF. Impact of biomedical and biopsychosocial training sessions on the attitudes, beliefs, and recommendations of health care providers about low back pain: a randomised clinical trial. Pain. 2011 Nov;152(11):2557-2563. doi: 10.1016/j.pain.2011.07.023. Epub 2011 Sep 13.
citation: Nissen N, Holm PM, Bricca A, Dideriksen M, Tang LH, Skou ST. Clinicians' beliefs and attitudes to physical activity and exercise therapy as treatment for knee and/or hip osteoarthritis: a scoping review. Osteoarthritis Cartilage. 2022 Feb;30(2):260-269. doi: 10.1016/j.joca.2021.11.008. Epub 2021 Nov 17.
citation: Moseley GL, Butler DS. Fifteen Years of Explaining Pain: The Past, Present, and Future. J Pain. 2015 Sep;16(9):807-13. doi: 10.1016/j.jpain.2015.05.005. Epub 2015 Jun 5.
citation: Bonatesta L, Ruiz-Cardenas JD, Fernandez-Azorin L, Rodriguez-Juan JJ. Pain Science Education Plus Exercise Therapy in Chronic Nonspecific Spinal Pain: A Systematic Review and Meta-analyses of Randomized Clinical Trials. J Pain. 2022 Apr;23(4):535-546. doi: 10.1016/j.jpain.2021.09.006. Epub 2021 Oct 20.
citation: Ordonez-Mora LT, Morales-Osorio MA, Rosero ID. Effectiveness of Interventions Based on Pain Neuroscience Education on Pain and Psychosocial Variables for Osteoarthritis: A Systematic Review. Int J Environ Res Public Health. 2022 Feb 23;19(5):2559. doi: 10.3390/ijerph19052559.
citation: Otis JD. Flor, H., & Turk, D. C. (2011)Chronic Pain: An Integrated Biobehavioral Approach Seattle: IASP Press. Cogn Behav Pract. 2013 Feb 1;20(1):117-8.
citation: El-Badawy MA, El Mikkawy DM. Sympathetic Dysfunction in Patients With Chronic Low Back Pain and Failed Back Surgery Syndrome. Clin J Pain. 2016 Mar;32(3):226-31. doi: 10.1097/AJP.0000000000000250.
citation: Bossenger NR, Lewis GN, Rice DA, Shepherd D. The autonomic and nociceptive response to acute exercise is impaired in people with knee osteoarthritis. Neurobiol Pain. 2023 Jan 19;13:100118. doi: 10.1016/j.ynpai.2023.100118. eCollection 2023 Jan-Jul.
citation: Adlan AM, Paton JF, Lip GY, Kitas GD, Fisher JP. Increased sympathetic nerve activity and reduced cardiac baroreflex sensitivity in rheumatoid arthritis. J Physiol. 2017 Feb 1;595(3):967-981. doi: 10.1113/JP272944. Epub 2016 Oct 24.
citation: Reyes del Paso GA, Garrido S, Pulgar A, Duschek S. Autonomic cardiovascular control and responses to experimental pain stimulation in fibromyalgia syndrome. J Psychosom Res. 2011 Feb;70(2):125-34. doi: 10.1016/j.jpsychores.2010.09.012. Epub 2010 Nov 18.
citation: Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
citation: Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
citation: NICE [Internet]. NICE; [cited 2024 Jan 29]. Osteoarthritis | NICE impact arthritis | Reviewing the impact of our guidance | Measuring the use of NICE guidance | Into practice | What we do | About. Available from: https://www.nice.org.uk/about/what-we-do/into-practice/measuring-the-use-of-nice-guidance/impact-of-our-guidance/nice-impact-arthritis/osteoarthritis
citation: Neogi T, Frey-Law L, Scholz J, Niu J, Arendt-Nielsen L, Woolf C, Nevitt M, Bradley L, Felson DT; Multicenter Osteoarthritis (MOST) Study. Sensitivity and sensitisation in relation to pain severity in knee osteoarthritis: trait or state? Ann Rheum Dis. 2015 Apr;74(4):682-8. doi: 10.1136/annrheumdis-2013-204191. Epub 2013 Dec 18.
citation: Neogi T, Guermazi A, Roemer F, Nevitt MC, Scholz J, Arendt-Nielsen L, Woolf C, Niu J, Bradley LA, Quinn E, Law LF. Association of Joint Inflammation With Pain Sensitization in Knee Osteoarthritis: The Multicenter Osteoarthritis Study. Arthritis Rheumatol. 2016 Mar;68(3):654-61. doi: 10.1002/art.39488.
citation: Plews DJ, Laursen PB, Stanley J, Kilding AE, Buchheit M. Training adaptation and heart rate variability in elite endurance athletes: opening the door to effective monitoring. Sports Med. 2013 Sep;43(9):773-81. doi: 10.1007/s40279-013-0071-8.
citation: Yarnitsky D, Granot M, Nahman-Averbuch H, Khamaisi M, Granovsky Y. Conditioned pain modulation predicts duloxetine efficacy in painful diabetic neuropathy. Pain. 2012 Jun;153(6):1193-1198. doi: 10.1016/j.pain.2012.02.021. Epub 2012 Apr 3.
citation: Finan PH, Buenaver LF, Bounds SC, Hussain S, Park RJ, Haque UJ, Campbell CM, Haythornthwaite JA, Edwards RR, Smith MT. Discordance between pain and radiographic severity in knee osteoarthritis: findings from quantitative sensory testing of central sensitization. Arthritis Rheum. 2013 Feb;65(2):363-72. doi: 10.1002/art.34646.
citation: Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract. 2001 Nov-Dec;4(6):256-62.
citation: Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014 Nov;67(11):1265-73. doi: 10.1016/j.jclinepi.2014.06.009. Epub 2014 Aug 3.
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
citation: Smarr KL, Keefer AL. Measures of depression and depressive symptoms: Beck Depression Inventory-II (BDI-II), Center for Epidemiologic Studies Depression Scale (CES-D), Geriatric Depression Scale (GDS), Hospital Anxiety and Depression Scale (HADS), and Patient Health Questionnaire-9 (PHQ-9). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S454-66. doi: 10.1002/acr.20556. No abstract available.
citation: Shelby RA, Somers TJ, Keefe FJ, DeVellis BM, Patterson C, Renner JB, Jordan JM. Brief Fear of Movement Scale for osteoarthritis. Arthritis Care Res (Hoboken). 2012 Jun;64(6):862-71. doi: 10.1002/acr.21626. Epub 2012 Jan 30.
citation: Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.
citation: Collins NJ, Prinsen CA, Christensen R, Bartels EM, Terwee CB, Roos EM. Knee Injury and Osteoarthritis Outcome Score (KOOS): systematic review and meta-analysis of measurement properties. Osteoarthritis Cartilage. 2016 Aug;24(8):1317-29. doi: 10.1016/j.joca.2016.03.010. Epub 2016 Mar 21.
citation: Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S208-28. doi: 10.1002/acr.20632. No abstract available.
citation: Norman CD, Skinner HA. eHealth Literacy: Essential Skills for Consumer Health in a Networked World. J Med Internet Res. 2006 Jun 16;8(2):e9. doi: 10.2196/jmir.8.2.e9.
citation: Chung SY, Nahm ES. Testing reliability and validity of the eHealth Literacy Scale (eHEALS) for older adults recruited online. Comput Inform Nurs. 2015 Apr;33(4):150-6. doi: 10.1097/CIN.0000000000000146.
citation: Rhodes RE, Hunt Matheson D, Mark R. Evaluation of Social Cognitive Scaling Response Options in the Physical Activity Domain. Meas Phys Educ Exerc Sci. 2010 Jul 30;14(3):137-50.
citation: Stanton TR, Braithwaite FA, Butler D, Moseley GL, Hill C, Milte R, Ratcliffe J, Maher C, Tomkins-Lane C, Pulling BW, MacIntyre E, Esterman A, Stanford T, Lee H, Fraysse F, Metcalf B, Mouatt B, Bennell K. The EPIPHA-KNEE trial: Explaining Pain to target unhelpful pain beliefs to Increase PHysical Activity in KNEE osteoarthritis - a protocol for a multicentre, randomised controlled trial with clinical- and cost-effectiveness analysis. BMC Musculoskelet Disord. 2021 Aug 28;22(1):738. doi: 10.1186/s12891-021-04561-6.