Comparing Pain Science Education to Biomedical Education for People With Knee Osteoarthritis: A Randomized Controlled Trial

NCT07823673 | Not Yet Recruiting

• 2 other identifiers: Hireb 20532EMPOWRD
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

Knee osteoarthritis (OA) is a common cause of pain and disability in older adults. Many people with knee OA believe that pain is primarily caused by joint damage or "wear and tear." These beliefs may contribute to fear of movement, reduced physical activity, and lower engagement in recommended self-management strategies. However, current evidence suggests that pain is influenced by multiple biological, psychological, and social factors and is not always directly related to the degree of structural joint changes visible on imaging. Pain Science Education (PSE) is an educational approach designed to improve understanding of pain by explaining the complex factors that contribute to the pain experience. In contrast, traditional biomedical education focuses primarily on structural joint pathology as the source of symptoms. Although patient education is recommended as a first-line intervention for knee OA, little is known about whether PSE is more effective than biomedical education in changing beliefs, improving disease understanding, or influencing behavior and physiological responses in older adults with knee OA. The purpose of this randomized controlled trial is to compare the effectiveness of PSE with standard biomedical education in community-dwelling older adults aged 55 years and older with knee OA. Eighty-two participants will be randomly allocated to receive either PSE or biomedical education through an interactive website-based educational platform. The primary outcome is osteoarthritis conceptualization, assessed using the Osteoarthritis Conceptualization Questionnaire (OACQ). Secondary outcomes include physiological measures of nervous system functioning, including heart rate variability, electrodermal activity, eye-tracking measures, and temporal summation testing. The study will also assess movement behaviors using accelerometry, including sleep, sedentary behavior, and physical activity across a 24-hour day. Additional outcomes include self-efficacy, fear of movement, knee pain, physical function, well-being, exercise intentions, and intentions regarding knee replacement surgery. Participants will complete baseline questionnaires and one week of physical activity monitoring before attending an in-person assessment. During the in-person visit, participants will complete physiological and sensory testing and review the educational materials assigned to their group. Participants will then complete a talk-aloud exercise to explore how they interpret and engage with the educational content. Following the visit, participants will complete a second week of physical activity monitoring and follow-up questionnaires. The investigators hypothesize that participants receiving PSE will demonstrate greater improvements in OA conceptualization than those receiving biomedical education. Exploratory analyses will examine whether PSE is associated with differences in nervous system responses, movement behaviors, self-reported outcomes, and whether these effects differ according to sex and gender. Findings from this study may help inform evidence-based educational strategies for older adults living with knee OA.

Conditions

Knee Arthritis Osteoarthritis

Keywords

knee osteoarthritis; pain neuroscience education

Outcome Measures

Primary Outcomes (1)

• Osteoarthritis Conceptualization Questionnaire (OACQ) score

  Osteoarthritis conceptualization assessed using the Osteoarthritis Conceptualization Questionnaire (OACQ). The OACQ measures participants' understanding and beliefs about osteoarthritis, pain, and physical activity. Higher scores indicate greater alignment with contemporary evidence-based concepts of osteoarthritis and pain.

  Change from baseline to 1 week post-intervention

Secondary Outcomes (14)

• Heart Rate Variability (HRV)

  during the intervention

• Electrodermal Activity (EDA)

  during the intervention

• Eye tracking

  during the intervention

• Mechanical Temporal Summation

  Change from pre-intervention to immediately post-intervention (same study visit)

• 24-hour movement behaviour composition

  Change from baseline (7-day monitoring period before intervention) to follow-up (7-day monitoring period after intervention)

Other Outcomes (1)

• Participant perceptions of educational content

  Immediately post-intervention (same study visit)

Study Arms (2)

Pain neuroscience education

EXPERIMENTAL

Participants randomized to the experimental arm will receive a web-based Pain Science Education (PSE) intervention designed for older adults with knee osteoarthritis. The educational content presents contemporary evidence regarding pain and osteoarthritis using a biopsychosocial framework. Topics include the multidimensional nature of pain, the limited relationship between pain and structural joint changes, factors that influence the pain experience, and the role of physical activity and self-management in osteoarthritis care. Educational materials include OA-related images, myths and facts, explanatory concepts, and patient-provider statements. Participants will review the content during a single study session and subsequently complete outcome assessments and a structured talk-aloud activity exploring their interpretation of the educational material.

Behavioral: Pain Science Education

Biomedical Education

ACTIVE COMPARATOR

Participants randomized to the control arm will receive a web-based biomedical education intervention focused on the structural and pathological aspects of knee osteoarthritis. The educational content presents osteoarthritis primarily as a condition associated with joint degeneration, cartilage loss, and other structural changes commonly described in traditional OA education. Materials include OA-related images, myths and facts, disease-related concepts, and patient-provider statements emphasizing joint pathology and disease progression. Participants will review the content during a single study session and subsequently complete outcome assessments and a structured talk-aloud activity exploring their interpretation of the educational material.

Behavioral: Biomedical Education

Interventions

Pain Science Education BEHAVIORAL

Participants receive a web-based Pain Science Education (PSE) intervention designed for older adults with knee osteoarthritis. The educational content presents contemporary concepts of pain using a biopsychosocial framework, emphasizing that pain is influenced by multiple biological, psychological, and social factors and is not always directly related to structural joint damage. Content includes images, myths and facts, disease-related concepts, and patient-provider statements encouraging physical activity and self-management.

Pain neuroscience education

Biomedical Education BEHAVIORAL

Participants receive a web-based biomedical education intervention focused on structural and pathological aspects of knee osteoarthritis. The educational content emphasizes joint degeneration, cartilage loss, osteophytes, and other structural changes commonly described in traditional osteoarthritis education. Content includes images, myths and facts, disease-related concepts, and patient-provider statements focused on joint pathology and disease progression.

Biomedical Education

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community-dwelling adults aged 55 years and older.
• Self-reported diagnosis of knee osteoarthritis by a physician and/or fulfillment of the National Institute for Health and Care Excellence (NICE) clinical criteria for knee osteoarthritis (activity-related joint pain and either no morning joint-related stiffness or morning stiffness lasting no longer than 30 minutes).
• Able to provide informed consent.
• Able to read and speak English.

You may not qualify if:

• Previous exposure to Pain Science Education (PSE), as determined by self-report.
• Eyeglass prescription exceeding ±6 diopters for spherical correction and/or ±3 diopters for astigmatism, due to eye-tracking equipment requirements.

Sponsors & Collaborators

• McMaster University: lead
• The McMaster Institute for Research on Aging (MIRA): collaborator

Related Publications (9)

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  PMID: 23794645 RESULT

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  PMID: 20451556 RESULT

• Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.

  PMID: 29034226 RESULT

• Miatke A, Stanford T, Olds T, Fraysse F, Maher C, Martin-Fernandez JA, Dumuid D. When the outcome is compositional: A method for conducting compositional response linear mixed models for physical activity, sedentary behaviour and sleep research. PLoS One. 2026 Jan 28;21(1):e0340373. doi: 10.1371/journal.pone.0340373. eCollection 2026.

  PMID: 41604394 RESULT

• 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 RESULT

• Pulling BW, Braithwaite FA, Butler DS, Vogelzang AR, Moseley GL, Catley MJ, Murray CM, Stanton TR. Item development and pre-testing of an Osteoarthritis Conceptualisation Questionnaire to assess knowledge and beliefs in people with knee pain. PLoS One. 2023 Sep 29;18(9):e0286114. doi: 10.1371/journal.pone.0286114. eCollection 2023.

  PMID: 37773973 RESULT

• Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.

  PMID: 31034380 RESULT

• Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.

  PMID: 31278997 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Lisa Carlesso

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Carlesso, PhD

CONTACT

289-680-5640; carlesl@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share