Physiological Impact of Different Types of Osteoarthritis Education.

NCT06400329 | Completed

• 1 other identifier: HiREB-16902
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Chronic Pain

Keywords

Pain Neuroscience Education (PNE); Osteoarthritis; Autonomic Nervous System (ANS); Physiological responses; Biomedical education

Outcome Measures

Primary Outcomes (5)

• Burden of the assessments

  Burden of completing the physical tests and questionnaires (0 = no burden, 10 = most burden)

  1 week post-intervention

• feasibility outcomes (recruitment rate)

  36 participants consent to participate in 3 months; ≥24 participants consent to participate in 3 months; \<24 participants consent to participate in 3 months

  at 3 months

• Feasibility outcomes (Educational content and format acceptability)

  ≥50% found content acceptable (Likert ≥4/5); ≥25% found content acceptable (Likert ≥4/5); \<25% found content acceptable (Likert ≥4/5)

  1 week post-intervention

• Feasibility outcomes (Lab Site accessibility/ Participant Convenience)

  ≥80% of participants find the lab accessible and convenient; ≥50% of participants find the lab accessible and convenient; \<50% of participants find the lab accessible and convenient.

  1 week post-intervention

• Feasibility outcomes (Scheduling of Lab assessments)

  ≥90% of scheduled assessments were on time; ≥75% of scheduled assessments were on time; \>50% of scheduled assessments were on time.

  1 week post-intervention

Secondary Outcomes (16)

• Demographic information

  At baseline

• Temporal Summation (TS)

  Before and after the delivery of the intervention

• Eye Tracker

  During the delivery of the intervention

• Galvanic Skin Response

  Before and during the delivery of the intervention

• Heart Rate variability

  Before and during delivery of the intervention

Study Arms (2)

Pain neuroscience education

EXPERIMENTAL

The educational content will be presented to the participants at a computer station in the format of a website to navigate to simulate the experience and information that they may come across while browsing the internet for information about knee OA. The content will include 4 components, regardless of the education type. These components include knee osteoarthritis (OA)-related images, facts and myths, disease related concepts, and patient-doctor statements. The distinction between the two educational approaches lies in how information is presented. PNE focuses more on the neurophysiology of pain and approaches it from the perspective that knee OA pain is manageable, using neutral to positive language and emphasizes the importance of physical function and staying active. After the educational content is delivered, the participants will be shown the content again and will be asked to talk aloud about each page that they were shown.

Other: Pain Neuroscience Education

Biomedical education

ACTIVE COMPARATOR

In Standard Pain Education, the emphasis is on the structural pathology of knee OA and the outdated but common understanding of the disease process as a degenerative one, potentially conveying negative and threatening language. After the educational content is delivered, the participants will be shown the content again and will be asked to talk aloud about each page that they were shown.

Other: Standard Pain Education

Interventions

Pain Neuroscience Education OTHER

PNE focuses more on the neurophysiology of pain and approaches it from the perspective that knee OA pain is manageable, using neutral to positive language and emphasizes the importance of physical function and staying active

Pain neuroscience education

Standard Pain Education OTHER

In Standard Pain Education, the emphasis is on the structural pathology of knee OA and the outdated but common understanding of the disease process as a degenerative one, potentially conveying negative and threatening language

Biomedical education

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

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

Sponsors & Collaborators

• Lisa Carlesso: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S1C7, Canada

Location

Related Publications (32)

• 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.

  PMID: 27351541 BACKGROUND

• 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.

  PMID: 14622702 BACKGROUND

• 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.

  PMID: 21917377 BACKGROUND

• 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.

  PMID: 34800632 BACKGROUND

• 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.

  PMID: 26051220 BACKGROUND

• 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.

  PMID: 34678468 BACKGROUND

• 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.

  PMID: 35270250 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25968450 BACKGROUND

• 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.

  PMID: 36711216 BACKGROUND

• 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.

  PMID: 27561790 BACKGROUND

• 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.

  PMID: 21262414 BACKGROUND

• 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.

  PMID: 23295957 BACKGROUND

• 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.

  PMID: 20053272 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 24351516 BACKGROUND

• 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.

  PMID: 26554395 BACKGROUND

• 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.

  PMID: 23852425 BACKGROUND

• 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.

  PMID: 22480803 BACKGROUND

• 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.

  PMID: 22961435 BACKGROUND

• 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.

  PMID: 11769298 BACKGROUND

• 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.

  PMID: 25091546 BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

• 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.

  PMID: 22588766 BACKGROUND

• 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.

  PMID: 22290689 BACKGROUND

• 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.

  PMID: 9699158 BACKGROUND

• 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.

  PMID: 27012756 BACKGROUND

• 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.

  PMID: 22588746 BACKGROUND

• 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.

  PMID: 16867972 BACKGROUND

• 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.

  PMID: 25783223 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 34454458 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Chronic Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Carlesso, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to study hypotheses and the two treatment groups. As both arms of the study are providing education-based interventions, 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, PT PhD

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 6, 2024
• Study Start: August 15, 2024
• Primary Completion: March 4, 2025
• Study Completion: September 22, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)