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临床试验/NCT06400329
NCT06400329已完成不适用

Evaluating the Physiological Impact of Pain Neuroscience Education Versus Standard Education for Older Adults With Osteoarthritis

Lisa Carlesso2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2024年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
37
试验地点
2
主要终点
Feasibility outcomes (Scheduling of Lab assessments)

研究概览

简要总结

In this study, the investigators are comparing two types of education for older adults with knee osteoarthritis: standard biomedical education focusing on the disease process, and a newer approach called pain neuroscience education (PNE), which teaches about the complexity of pain and dispels myths. While PNE has shown benefits in self-reported pain and function, little is known about its effects on physiological responses to pain.

the investigators will measure physiological indicators, particularly activity in the autonomic nervous system (ANS), which is closely linked to pain. Dysregulation in the ANS is common in chronic pain conditions like osteoarthritis. Our study aims to assess the feasibility of comparing these education methods and explore differences in physiological responses, as well as self-reported outcomes like cognitive and emotional factors.

Our goals are to determine if the study protocol is feasible, assess participants' acceptance of the assessment procedures, and explore differences in physiological markers and self-reported outcomes between the two education groups. Ultimately, the investigators aim to understand how different educational approaches may affect nervous system processing in older adults with knee osteoarthritis. the investigators hypothesize that those receiving PNE will show less autonomic arousal and nervous system sensitivity compared to those receiving standard education.

详细描述

Education and understanding of musculoskeletal (MSK) pain is known to be important for individuals and can improve patient outcomes (i.e. pain and function)(1). Many years ago, it became apparent that there was a vast disconnect between the scientific understanding of pain (i.e. its protective function, its complexity, and the most effective ways of treating it) and the current understanding of 'how pain works' held by patients and health professionals alike(2), one that was entrenched in an outdated biomedical model. Traditionally education has focused on the disease process which can have a negative impact with its language and images due to its focus on structural pathology.(3) Additionally, despite the known benefits of certain interventions e.g. exercise for MSK disorders, people may be wrongly advised that too much exercise could cause joint pain and damage.(4) Many of these poorly construed messages are due to a lack of understanding of the impact of such language, the complexity of the pain experience, and its lack of correlation with what the investigators now consider to be normal age-related changes seen on imaging.(2) The aim of intensive education about pain neuroscience was to give credibility to the best treatments available - active, psychological and self-management skills by providing a modern understanding of how pain works with the hope of giving power and agency to individuals to make optimal decisions about how to manage their health situation. Simply put, PNE aimed to enable and empower patients to adopt a biopsychosocial understanding of their problem and thereby pursue a biopsychosocial-based approach to overcoming it.(2) PNE involves the process of educating individuals about the complexity of pain and how our bodies process pain. It also seeks to dispel many of the myths long held by the public regarding MSK disorders(5). Despite PNE showing consistent positive effects on self-reported pain and function, there has been a growing debate in the literature regarding its value(6,7) Interestingly, there has been little to no evaluation of how differing approaches to education impacts people's physiological reactions and nervous system processing of pain. This project will fill that gap by providing unique understanding of how the type of educational content provided to older adults with knee osteoarthritis may impact their nervous system functioning and processing of pain.

Measuring pain remains a challenge, especially from a psycho-physiological aspect(8). Among various physiological indicators, the activity of the autonomic nervous system (ANS), specifically its sympathetic and parasympathetic subdivisions, is closely associated with pain (9). Enhanced activity in the sympathetic nervous system leads to increased electrodermal activity (sweating), respiration rate, heart rate, blood pressure, vascular vasoconstriction, and pupil dilation. In states of chronic pain, the autonomic nervous system may experience dysregulation, often resulting in diminished autonomic responsiveness to painful or stressful stimuli. Autonomic dysfunction has been observed in various chronic conditions, including knee osteoarthritis(10), low back pain(9), rheumatoid arthritis(11), and fibromyalgia(12). Targeting the dysregulated autonomic nervous system could potentially restore balance to stress response systems and alleviate systemic inflammation. The purpose of this pilot study will be to evaluate 1) the feasibility of a study protocol to investigate if there are differences in physiological responses associated with exposure to different types of knee osteoarthritis educational content. 2) to explore differences in the physiological responses between exposure to pain neuroscience education and standard biomedical education and 3) to explore differences in self-reported cognitive, emotional and functional outcomes and the physiological responses in each intervention arm

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants will be blinded to study hypotheses and the two treatment groups. As both arms of the study are providing education-based interventions, participants will be provided limited details of each intervention arm so as to blind them from knowing which is the intervention and which is the control. This will help minimize any bias that occurs by knowledge of group assignment and perception of treatment effects.

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥ 55-85years old
  • community dwelling adults with a diagnosis of knee osteoarthritis or fulfilling the NICE criteria for knee OA
  • activity-related joint pain
  • either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes

排除标准

  • those who have received prior PNE
  • those who have eye glasses prescription exceeding +/- 6 for spherical correction and/or +3 for astigmatism

结局指标

主要结局

Feasibility outcomes (Scheduling of Lab assessments)

时间窗: 1 week post-intervention

≥90% of scheduled assessments were on time; ≥75% of scheduled assessments were on time; \>50% of scheduled assessments were on time.

feasibility outcomes (recruitment rate)

时间窗: at 3 months

36 participants consent to participate in 3 months; ≥24 participants consent to participate in 3 months; \<24 participants consent to participate in 3 months

Burden of the assessments

时间窗: 1 week post-intervention

Burden of completing the physical tests and questionnaires (0 = no burden, 10 = most burden)

Feasibility outcomes (Educational content and format acceptability)

时间窗: 1 week post-intervention

≥50% found content acceptable (Likert ≥4/5); ≥25% found content acceptable (Likert ≥4/5); \<25% found content acceptable (Likert ≥4/5)

Feasibility outcomes (Lab Site accessibility/ Participant Convenience)

时间窗: 1 week post-intervention

≥80% of participants find the lab accessible and convenient; ≥50% of participants find the lab accessible and convenient; \<50% of participants find the lab accessible and convenient.

次要结局

  • Galvanic Skin Response(Before and during the delivery of the intervention)
  • Demographic information(At baseline)
  • Temporal Summation (TS)(Before and after the delivery of the intervention)
  • Eye Tracker(During the delivery of the intervention)
  • Heart Rate variability(Before and during delivery of the intervention)
  • Respiratory Rate(Before and during delivery of the intervention)
  • Chronic pain self-efficacy(Before and after the delivery of the intervention)
  • Fear of movement(Before and after the delivery of the intervention)
  • The Osteoarthritis Conceptualization Questionnaire(Before and after the delivery of the intervention)
  • Anxiety symptoms(Before and after the delivery of the intervention)
  • Knee injury and outcomes(Before and after the delivery of the intervention)
  • eHEALS(Before the delivery of the intervention)
  • The Intention to Exercise scale(Before and after the delivery of the intervention)
  • The surgery intention scale(Before and after the delivery of the intervention)
  • The Self-Administered Comorbidity Questionnaire (SCQ)(Before the delivery of the intervention)
  • Satisfaction with Information Quality(After the delivery of the intervention)

研究者

发起方
Lisa Carlesso
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lisa Carlesso

Associate Professor, PT PhD

McMaster University

研究点 (2)

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