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

September 14, 2026 updated by: Lisa Carlesso, McMaster University

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pain neuroscience education
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
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.
Active Comparator: Biomedical Education
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 1 week post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the intervention
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.
during the intervention
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.
during the intervention
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.
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)
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.
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
Self-efficacy for managing chronic health conditions assessed using the SEMCD-6 questionnaire. Higher scores indicate greater self-efficacy.
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
Fear of movement related to osteoarthritis assessed using the BFMSO. Higher scores indicate greater fear of movement.
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 pain assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale. Higher scores indicate fewer knee problems.
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
Physical function assessed using the KOOS Activities of Daily Living subscale. Higher scores indicate better function.
Change from baseline to 1 week post-intervention
Well-being of Older People (WOOP)
Time Frame: Change from baseline to 1 week post-intervention
Multidimensional well-being assessed using the WOOP questionnaire.
Change from baseline to 1 week post-intervention
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.
Change from baseline to 1 week post-intervention
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.
Change from baseline to 1 week post-intervention
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
Baseline
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.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately post-intervention (same study visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

The McMaster Institute for Research on Aging (MIRA)

Investigators

  • Principal Investigator: Lisa Carlesso, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 14, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hireb 20532
  • EMPOWRD (Other Identifier: McMaster Institute for Research on Aging)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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