Physiological Impact of Different Types of Osteoarthritis Education. Education

Chronic Pain Clinical Trial

— PNE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06400329
• Other study ID #: HiREB-16902
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: McMaster University
• Contact: Lisa Carlesso, PhD
• Phone: 289 680 5640
• Email: carlesl[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• =55 years 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

Exclusion Criteria:

• those who have received prior PNE

Related Conditions & MeSH terms

• Chronic Pain
• Osteoarthritis

Intervention

Other:
• Pain Neuroscience Education
PNE focuses more on the neurophysiology of pain and approaches it from the perspective that knee OA pain is manageable, using neutral to positive language and emphasizes the importance of physical function and staying active
• Standard Pain Education
In Standard Pain Education, the emphasis is on the structural pathology of knee OA and the outdated but common understanding of the disease process as a degenerative one, potentially conveying negative and threatening language

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lisa Carlesso

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Burden of the assessments	Burden of completing the physical tests and questionnaires (0 = no burden, 10 = most burden)	1 week post-intervention
Primary	feasibility outcomes (recruitment rate)	36 participants consent to participate in 3 months; =24 participants consent to participate in 3 months; <24 participants consent to participate in 3 months	at 3 months
Primary	Feasibility outcomes (Educational content and format acceptability)	=50% found content acceptable (Likert =4/5); =25% found content acceptable (Likert =4/5); <25% found content acceptable (Likert =4/5)	1 week post-intervention
Primary	Feasibility outcomes (Lab Site accessibility/ Participant Convenience)	=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.	1 week post-intervention
Primary	Feasibility outcomes (Scheduling of Lab assessments)	=90% of scheduled assessments were on time; =75% of scheduled assessments were on time; >50% of scheduled assessments were on time.	1 week post-intervention
Secondary	Demographic information	age, sex, gender, education, marital status, race, height, and weight	At baseline
Secondary	Temporal Summation (TS)	Quantitative sensory testing in the form of mechanical temporal summation will be conducted to assess central nervous system sensitivity. We will use a 512mN weighted probe applied at the volar wrist opposite to the index knee (or least painful knee). It will be applied once and participants will be asked to rate their pain between 0 and 100.(16,17) Then, the same stimulus is applied 10 times at the rate of 1 per second and they are asked again to rate their pain. TS is defined as being present when, compared with the initial trial, the participant reports increased pain following the second trial.(16) This method has been used in many patient populations(18) including people with knee OA.(19)	Before and after the delivery of the intervention
Secondary	Eye Tracker	Participants will be seated 63-65cm away from the display, which is the optimal distance determined by Tobii. Participants will be asked to fixate and follow with their gaze a red circle moving on the screen. The Tobii X2-60 Eye Tracker is an unobtrusive eye tracker for detailed research of natural eye gaze behavior. It is a standalone remote device (no contact with the participant) that is attached to the display. The tracker uses infrared diodes or LEDs to generate reflection patterns on the corneas of the participants' eyes. These reflection patterns, together with other visual data about the participants, are collected by the device's image sensors (at 60 Hz, or data points per second), and allows it to accurately calculate the participants' gaze point with high temporal and spatial precision. Its large head movement box allows the subject to move during recording while maintaining accuracy and precision.	During the delivery of the intervention
Secondary	Galvanic Skin Response	Reciprocal of the measure of how much resistance the skin of an organism in a state of rest or basal activity offers to passage of an electrical current. For each participant only 2 electrodes are required at either of the locations indicated in the graphic. We will only be using locations 1-4 or 9-10 depending on which provides the best signal to noise ratio for each experimental task after pilot testing. Used with EL507 disposable snap electrodes that are designed for electrodermal activity studies and are pre-gelled with isotonic gel. The latex-free electrodes conform and adhere well to the body. The conductive gel used is medically approved BIOPAC non-irritating, isotonic Gel 101. It has the following components: Cetyl Alcohol #697313, Glycerol Monostearate, Lanolin, USP Anhydrous, Dimenthicon Silicone TBF9-1000, Water, purified USP Sodium Chloride, Sodium Lauryl Sulfate, Sorbitol, 70 USP, Methylparaben, Propylparaben, Quaternium-15	During the delivery of the intervention
Secondary	Heart Rate variability	ECG data will be collected with participants in a seated position to minimize potential parasympathetic saturation. Participants will be instructed to maintain regular sleep, avoid caffeine, alcohol, and physical exercise within 24 hours of the visit. Participants will also empty their bladders before the session. The data acquisition will be performed using BIOPAC MP160 equipment. Participants will be instructed to remain motionless and silence throughout this period. Lead II will be chosen for data recording due to its anticipated higher R peak compared to leads I and III. Electrode placement will involve connecting the positive terminal to the left leg (LL), the negative terminal to the right arm (RA), and grounding to the right leg (RL). Heart Rate Variability (HRV) will be assessed using the Acqknowledge software, which is attached to the BioPac system (MP160, USA)	Before and during delivery of the intervention
Secondary	Respiratory Rate	To monitor respiration, a strain gauge respiration belt (BIOPAC SS5LB; BIOPAC Systems Inc., Coletta, CA, USA) will be positioned at the midpoint between the navel and xiphoid process. The acquired respiration rate data from the belt will be transmitted to the acquisition system and analyzed using AcqKnowledge software version 5.0.; A small training task will be utilized to familiarize the participants with the experimental procedure, get them comfortable with the lab environment and to establish a baseline for each participant. Participants will be given instructions for the task, the outcome of this task will have no effect on the study findings.	Before and during delivery of the intervention
Secondary	Chronic pain self-efficacy	The Self-Efficacy for Managing Chronic Disease 6-item scale (SEMCD-6) will be used to measure self-efficacy for chronic pain sufferers, with higher reported scores indicating higher self-efficacy.(21) Items are measured on a 0-10 scale with higher scores indicating higher self-efficacy. The SEMCD-6 has reported to have high internal consistency (Chronbach alpha of 0.88), sensitive to change, with significant correlations with other health outcomes.(22)	Before and after the delivery of the intervention
Secondary	Anxiety symptoms	The anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety.(23) The HADS consists of 7 questions to measure anxiety with higher scores representing increased severity in anxiety symptoms. Each item is rated on a 4-point scale (ranging from 0 = no not at all, to 3 = yes definitely), for a total score ranging from 0-21. Two items are reverse scored (ranging from 3 = no not at all, to 0 = yes definitely). It is a brief and reliable measure of emotional distress in general in chronic populations including chronic pain and rheumatology.(24) Average sensitivity and specificity is = 0.80.(24)	Before and after the delivery of the intervention
Secondary	Fear of movement	The Brief Fear of Movement Scale for Osteoarthritis (BFMSO) will be used to assess activity avoidance of participants due to pain-related fear of movement.(25) The BFMSO has 6 items that are derived from the Tampa Scale for Kinesiophobia (TSK) and uses a 4-point Likert scale with higher values indicating higher levels of kinesiophobia.(25) The BFMSO has adequate convergent validity with measures of pain (ß=.30 to .41), physical functioning (ß=.44 to .48), and psychological functioning (ß=.36 to .37).(25)	Before and after the delivery of the intervention
Secondary	Knee injury and outcomes	The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, used to assess self-reported opinions about patients' knee and associated problems, while evaluating short-term and long-term consequences of knee injury. There are 42 items in 5 scored sub scales, of which two will be used: 1) pain, and 2) function in daily living (ADL). Scores range from 0-100 with zero representing extreme knee problems and 100 representing no knee problems.(26) KOOS has adequate internal consistency (0.70-0.95) and construct validity in adults with knee OA.(27) Multiple studies have determined convergent and divergent construct validity with comparison to several instruments including the subscales of SF-36 and the Lysholm knee scoring scale.(28)	Before and after the delivery of the intervention
Secondary	eHEALS	Electronic health literacy was defined initially as "the ability to seek, find, understand, and appraise health information from electronic sources and apply the knowledge gained to addressing or solving a health problem" (p.2)(29). One of the measures of electronic health literacy is eHEALS. It comprises 8 items and respondents rate each item on a 5-point Likert Scale spanning from 1 (strongly disagree) to 5 (strongly agree). The higher value in each item represents a greater perception of eHealth literacy (30). eHEALS has adequate internal consistency (a = .94) and validity in adults with knee OA(31).	Before and after the delivery of the intervention
Secondary	The Osteoarthritis Conceptualization Questionnaire	The Osteoarthritis Conceptualization Questionnaire (OACQ) aims to explore individuals' perspectives on osteoarthritis and physical activity through a set of statements. Respondents are instructed to express their agreement or disagreement on a scale ranging from "Strongly Disagree=1" to "Strongly Agree=5." The questionnaire is divided into four sections: Influence of Variables, Physiology, Expectations, and Conceptual Change. Each section involves specific items, and some require reverse scoring. The OACQ demonstrates good test-retest reliability (ICC(3,1)= 0.89). Measures of convergent validity revealed a moderate correlation with other related scales.	Before and after the delivery of the intervention
Secondary	The Intention to Exercise scale	The Intention to Exercise scale involves three key questions: "I am committed to engage in physical activity over the next 2 weeks"; "I am motivated to engage in physical activity over the next 2 weeks" and "I am determined to engage in physical activity over the next 2 weeks"(32) . Participants are asked to rate their agreement on a 7-point Likert scale, ranging from "very strongly disagree" to "very strongly agree," This scale offers an understanding of participants' intentions and attitudes towards incorporating physical activity into their lives(33).	Before and after the delivery of the intervention
Secondary	The surgery intention scale	The surgery intention scale aimed to assess individuals' inclination toward knee joint replacement surgery. The responses, ranging from 'Yes,' 'No,' to 'Unsure,' provide valuable data on immediate surgery acceptance. This scale offers a comprehensive understanding of participants' attitudes and intentions regarding this specific surgical intervention (6).	Before and after the delivery of the intervention