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NCT Number: NCT07823673

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

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.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Knee osteoarthritis (OA) is one of the leading causes of persistent pain and disability among older adults worldwide. Contemporary clinical guidelines consistently recommend patient education, exercise, physical activity, and self-management as first-line interventions for individuals with knee OA. Despite these recommendations, many people with knee OA continue to hold beliefs that pain is primarily a consequence of structural joint damage, cartilage loss, or joint degeneration. These beliefs may contribute to fear of movement, reduced participation in physical activity, lower self-efficacy, and pessimistic expectations regarding recovery and long-term management.

Historically, OA has often been communicated through a biomedical framework emphasizing structural pathology and "wear-and-tear" explanations. Although structural changes can contribute to symptoms, growing evidence suggests that the relationship between imaging findings and pain severity is modest. Structural abnormalities commonly observed on imaging are frequently present in asymptomatic individuals and may reflect age-related changes rather than direct causes of pain. Nevertheless, many patients continue to receive messages that reinforce damage-focused beliefs and may discourage engagement in recommended management strategies.

Pain Science Education (PSE) was developed to address misconceptions regarding pain and musculoskeletal conditions. PSE aims to promote a contemporary understanding of pain by explaining the interaction of biological, psychological, and social contributors to the pain experience. In the context of knee OA, PSE emphasizes that pain is influenced by multiple factors and does not necessarily reflect ongoing tissue damage. It also promotes the understanding that movement and physical activity are generally safe, beneficial, and important components of OA management.

A central objective of PSE is conceptual change. Conceptual change refers to modifications in how individuals understand and interpret their condition and pain experience. Improved conceptualization of OA may facilitate more adaptive beliefs about pain, increase confidence in self-management, and support engagement in evidence-based treatments such as exercise and physical activity. However, little is known about the effectiveness of PSE in older adults with knee OA, particularly when compared with more traditional biomedical educational approaches.

A pilot randomized controlled trial conducted by the investigative team found that participants receiving PSE demonstrated improvements in osteoarthritis conceptualization, whereas participants receiving biomedical education showed little change. Although between-group differences did not reach statistical significance, the pilot study was not powered to detect treatment effects. These findings support the need for a fully powered randomized controlled trial.

In addition to influencing beliefs and understanding, educational interventions may affect behavioral and physiological outcomes. One proposed mechanism is through increasing participants' confidence to engage in physical activity by changing beliefs that pain necessarily indicates tissue damage. Because daily movement behaviors are interdependent, understanding changes in physical activity requires consideration of the entire 24-hour movement composition, including sleep, sedentary behavior, and different intensities of physical activity. Compositional Data Analysis (CoDA) provides an appropriate framework for investigating these relationships.

Educational interventions may also influence physiological responses associated with pain and stress processing. Chronic pain has been associated with alterations in autonomic nervous system regulation, including changes in sympathetic and parasympathetic activity. Physiological measures such as heart rate variability, electrodermal activity, eye-tracking metrics, and quantitative sensory testing may provide objective indicators of nervous system responsiveness and processing. Evaluating these measures may improve understanding of how individuals respond to different educational messages regarding pain and osteoarthritis.

The present study is a two-arm randomized controlled trial comparing Pain Science Education and Biomedical Education in community-dwelling older adults with knee OA. Participants will be randomly allocated to receive one of two website-based educational interventions designed to simulate information commonly encountered when searching for OA-related information online. Both educational programs include similar formats and presentation methods but differ in the concepts and messages emphasized. The biomedical education intervention focuses primarily on structural pathology and disease-related tissue changes, whereas the PSE intervention focuses on contemporary pain science principles and a biopsychosocial understanding of osteoarthritis pain.

The primary objective of the study is to determine whether PSE results in greater improvement in osteoarthritis conceptualization than biomedical education immediately following exposure to the intervention. Secondary objectives are to explore differences between groups in physiological measures of nervous system function, movement behaviors measured across the 24-hour day, and self-reported cognitive, emotional, and functional outcomes. The study will also explore how participants perceive, interpret, and engage with the educational content through a talk-aloud methodology. In addition, exploratory analyses will investigate the potential influence of sex and gender on treatment responses across outcome domains.

The results of this study will contribute to the understanding of how educational interventions influence beliefs, behavior, and physiological responses in individuals with knee OA. Findings may help inform the development of evidence-based educational strategies that support self-management, physical activity participation, and patient-centered osteoarthritis care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Osteoarthritis Conceptualization Questionnaire (OACQ) score

    Time frame: Change from baseline to 1 week post-intervention

    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.

Secondary outcomes

  1. Heart Rate Variability (HRV)

    Time frame: during the intervention

    Autonomic nervous system function assessed using heart rate variability derived from electrocardiogram recordings collected while participants interact with the educational material.

  2. Electrodermal Activity (EDA)

    Time frame: during the intervention

    Sympathetic nervous system activity assessed through continuous electrodermal activity recordings obtained while participants review the educational material.

  3. Eye tracking

    Time frame: during the intervention

    Visual attention and cognitive processing assessed using eye-tracking metrics, including gaze behavior (e.g. location and time spent on content) while participants review educational content.

  4. Mechanical Temporal Summation

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

    Central nervous system sensitivity assessed using mechanical temporal summation testing. Higher values indicate greater pain facilitation.

  5. 24-hour movement behaviour composition

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

    Distribution of time spent sleeping, sedentary, and engaging in light, moderate, vigorous, and very vigorous physical activity measured using accelerometry and analyzed using compositional data analysis.

  6. Self-Efficacy for Managing Chronic Disease (SEMCD-6)

    Time frame: Change from baseline to 1 week post-intervention

    Self-efficacy for managing chronic health conditions assessed using the SEMCD-6 questionnaire. Higher scores indicate greater self-efficacy.

  7. Brief Fear of Movement Scale for Osteoarthritis (BFMSO)

    Time frame: Change from baseline to 1 week post-intervention

    Fear of movement related to osteoarthritis assessed using the BFMSO. Higher scores indicate greater fear of movement.

  8. Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale

    Time frame: Change from baseline to 1 week post-intervention

    Knee pain assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale. Higher scores indicate fewer knee problems.

  9. Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living Subscale

    Time frame: Change from baseline to 1 week post-intervention

    Physical function assessed using the KOOS Activities of Daily Living subscale. Higher scores indicate better function.

  10. Well-being of Older People (WOOP)

    Time frame: Change from baseline to 1 week post-intervention

    Multidimensional well-being assessed using the WOOP questionnaire.

  11. Intention to Exercise

    Time frame: Change from baseline to 1 week post-intervention

    Participants' motivation, commitment, and determination to engage in physical activity assessed using the Intention to Exercise scale.

  12. Intention to undergo knee replacement surgery

    Time frame: Change from baseline to 1 week post-intervention

    Participants' willingness to consider knee joint replacement surgery assessed using the Surgery Intention Scale.

  13. Computer Proficiency Questionnaire-12 (CPQ-12)

    Time frame: Baseline

    Self-reported computer proficiency assessed using the Computer Proficiency Questionnaire-12. Higher scores indicate greater perceived ability to perform computer-based tasks and use digital technologies. Scores range from 12 to 60

  14. Attitudes Toward Technologies Questionnaire (ATTQ)

    Time frame: Baseline

    Attitudes toward technology assessed using the ATTQ. Higher scores indicate more positive attitudes toward technology use. Scores range from 6 to 30.

Other outcomes

  1. Participant perceptions of educational content

    Time frame: Immediately post-intervention (same study visit)

    The will be qualitatively evaluated using participants' interpretations, perceptions, and engagement with the educational materials explored through a structured talk-aloud exercise.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Carlesso, PhD

CONTACT

[email protected]

289-680-5640

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • The McMaster Institute for Research on Aging (MIRA)

Registry information

Official study title

Effects of Pain Neuroscience Education Compared to Biomedical Education on Disease Conceptualization for Older Adults With Knee Osteoarthritis: A Randomized Controlled Trial

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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