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

2026年9月14日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

82

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
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.
有源比较器: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.
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Osteoarthritis Conceptualization Questionnaire (OACQ) score
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Heart Rate Variability (HRV)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
大体时间: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
大体时间: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)
大体时间: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)
大体时间:Baseline
Attitudes toward technology assessed using the ATTQ. Higher scores indicate more positive attitudes toward technology use. Scores range from 6 to 30.
Baseline

其他结果措施

结果测量
措施说明
大体时间
Participant perceptions of educational content
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Lisa Carlesso、McMaster University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年2月1日

初级完成 (估计的)

2028年4月1日

研究完成 (估计的)

2028年4月1日

研究注册日期

首次提交

2026年9月8日

首先提交符合 QC 标准的

2026年9月14日

首次发布 (实际的)

2026年9月16日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月14日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • Hireb 20532
  • EMPOWRD (其他标识符:McMaster Institute for Research on Aging)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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