Knee Arthritis OsteoarthritisNCT07823673
Comparing Pain Science Education to Biomedical Education for People With Knee Osteoarthritis: A Randomized Controlled Trial
A study testing Pain Science Education and Biomedical Education in people with Knee Arthritis Osteoarthritis, run by McMaster University.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Knee Arthritis Osteoarthritis
- What is being tested?
- Pain Science Education and Biomedical Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2027to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Pain Neuroscience Education Compared to Biomedical Education on Disease Conceptualization for Older Adults 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Knee Arthritis Osteoarthritis
- Being tested
- Pain Science Education, Biomedical Education
- Keywords
- knee osteoarthritis, pain neuroscience education
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Science EducationBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Biomedical Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 1 week post-intervention
Secondary outcomes (14)
Heart Rate Variability (HRV)
Autonomic nervous system function assessed using heart rate variability derived from electrocardiogram recordings collected while participants interact with the educational material.
Measured: during the intervention
Electrodermal Activity (EDA)
Sympathetic nervous system activity assessed through continuous electrodermal activity recordings obtained while participants review the educational material.
Measured: during the intervention
Eye tracking
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.
Measured: during the intervention
Mechanical Temporal Summation
Central nervous system sensitivity assessed using mechanical temporal summation testing. Higher values indicate greater pain facilitation.
Measured: Change from pre-intervention to immediately post-intervention (same study visit)
24-hour movement behaviour composition
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.
Measured: Change from baseline (7-day monitoring period before intervention) to follow-up (7-day monitoring period after intervention)
Self-Efficacy for Managing Chronic Disease (SEMCD-6)
Self-efficacy for managing chronic health conditions assessed using the SEMCD-6 questionnaire. Higher scores indicate greater self-efficacy.
Measured: Change from baseline to 1 week post-intervention
Brief Fear of Movement Scale for Osteoarthritis (BFMSO)
Fear of movement related to osteoarthritis assessed using the BFMSO. Higher scores indicate greater fear of movement.
Measured: Change from baseline to 1 week post-intervention
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale
Knee pain assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale. Higher scores indicate fewer knee problems.
Measured: Change from baseline to 1 week post-intervention
Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living Subscale
Physical function assessed using the KOOS Activities of Daily Living subscale. Higher scores indicate better function.
Measured: Change from baseline to 1 week post-intervention
Well-being of Older People (WOOP)
Multidimensional well-being assessed using the WOOP questionnaire.
Measured: Change from baseline to 1 week post-intervention
Intention to Exercise
Participants' motivation, commitment, and determination to engage in physical activity assessed using the Intention to Exercise scale.
Measured: Change from baseline to 1 week post-intervention
Intention to undergo knee replacement surgery
Participants' willingness to consider knee joint replacement surgery assessed using the Surgery Intention Scale.
Measured: Change from baseline to 1 week post-intervention
Computer Proficiency Questionnaire-12 (CPQ-12)
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
Measured: Baseline
Attitudes Toward Technologies Questionnaire (ATTQ)
Attitudes toward technology assessed using the ATTQ. Higher scores indicate more positive attitudes toward technology use. Scores range from 6 to 30.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Knee Arthritis OsteoarthritisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- The McMaster Institute for Research on Aging (MIRA)
- Responsible party
- Principal investigator, Lisa Carlesso, McMaster University
- Investigators
- Lisa Carlesso, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823673
- Sponsor's protocol ID
- Hireb 20532
- Other IDs
- EMPOWRD
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to restrictions outlined in the research ethics approval and informed consent process. Given the collection of detailed physiological, movement behavior, and qualitative data, public sharing may increase the risk of participant re-identification despite de-identification procedures.
Publications
Hackert MQN, van Exel J, Brouwer WBF. Well-being of Older People (WOOP): Quantitative validation of a new outcome measure for use in economic evaluations. Soc Sci Med. 2020 Aug;259:113109. doi: 10.1016/j.socscimed.2020.113109. Epub 2020 Jun 13.
PubMed 32629325Bartley EJ, Fillingim RB. Sex differences in pain: a brief review of clinical and experimental findings. Br J Anaesth. 2013 Jul;111(1):52-8. doi: 10.1093/bja/aet127.
PubMed 23794645Benedek M, Kaernbach C. A continuous measure of phasic electrodermal activity. J Neurosci Methods. 2010 Jun 30;190(1):80-91. doi: 10.1016/j.jneumeth.2010.04.028. Epub 2010 May 6.
PubMed 20451556Shaffer 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.
PubMed 29034226Miatke 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.
PubMed 41604394Louw 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.
PubMed 27351541Pulling 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.
PubMed 37773973Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.
PubMed 31034380Bannuru 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.
PubMed 31278997
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pain Neuroscience Education Compared to Biomedical Education on Disease Conceptualization for Older Adults With Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07823673
- Acronym / sponsor ID
- Hireb 20532
- Conditions
- Knee Arthritis Osteoarthritis
- Keywords
- knee osteoarthritis, pain neuroscience education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- The McMaster Institute for Research on Aging (MIRA)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain neuroscience education | Experimental | Behavioral: Pain Science EducationParticipants 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. |
| Biomedical Education | Active comparator | Behavioral: Biomedical EducationParticipants 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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Science EducationParticipants 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. | Behavioural | Pain neuroscience education |
| Biomedical EducationParticipants 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. | Behavioural | Biomedical Education |
Primary outcome
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.
14 secondary outcomes
Heart Rate Variability (HRV)
Time frame: during the intervention
Electrodermal Activity (EDA)
Time frame: during the intervention
Eye tracking
Time frame: during the intervention
Mechanical Temporal Summation
Time frame: Change from pre-intervention to immediately post-intervention (same study visit)
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)
Self-Efficacy for Managing Chronic Disease (SEMCD-6)
Time frame: Change from baseline to 1 week post-intervention
Brief Fear of Movement Scale for Osteoarthritis (BFMSO)
Time frame: Change from baseline to 1 week post-intervention
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale
Time frame: Change from baseline to 1 week post-intervention
Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living Subscale
Time frame: Change from baseline to 1 week post-intervention
Well-being of Older People (WOOP)
Time frame: Change from baseline to 1 week post-intervention
Intention to Exercise
Time frame: Change from baseline to 1 week post-intervention
Intention to undergo knee replacement surgery
Time frame: Change from baseline to 1 week post-intervention
Computer Proficiency Questionnaire-12 (CPQ-12)
Time frame: Baseline
Attitudes Toward Technologies Questionnaire (ATTQ)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Results publication: PubMed 32629325Hackert MQN, van Exel J, Brouwer WBF. Well-being of Older People (WOOP): Quantitative validation of a new outcome measure for use in economic evaluations. Soc Sci Med. 2020 Aug;259:113109. doi: 10.1016/j.socscimed.2020.113109. Epub 2020 Jun 13.
- Results publication: PubMed 23794645Bartley EJ, Fillingim RB. Sex differences in pain: a brief review of clinical and experimental findings. Br J Anaesth. 2013 Jul;111(1):52-8. doi: 10.1093/bja/aet127.
- Results publication: PubMed 20451556Benedek M, Kaernbach C. A continuous measure of phasic electrodermal activity. J Neurosci Methods. 2010 Jun 30;190(1):80-91. doi: 10.1016/j.jneumeth.2010.04.028. Epub 2010 May 6.
- Results publication: PubMed 29034226Shaffer 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.
- Results publication: PubMed 41604394Miatke 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.
- Results publication: PubMed 27351541Louw 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.
- Results publication: PubMed 37773973Pulling 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.
- Results publication: PubMed 31034380Hunter DJ, Bierma-Zeinstra S. Osteoarthritis. Lancet. 2019 Apr 27;393(10182):1745-1759. doi: 10.1016/S0140-6736(19)30417-9.
- Results publication: PubMed 31278997Bannuru 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to restrictions outlined in the research ethics approval and informed consent process. Given the collection of detailed physiological, movement behavior, and qualitative data, public sharing may increase the risk of participant re-identification despite de-identification procedures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Carlesso principal investigator
McMaster University
Questions about this trial
What is this clinical trial studying?
A study testing Pain Science Education and Biomedical Education in people with Knee Arthritis Osteoarthritis, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Carlesso, PhD (289-680-5640, carlesl@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteoarthritis Conceptualization Questionnaire (OACQ) score (time frame: Change from baseline to 1 week post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07823673, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.