OsteoarthritisPNENCT06400329
Physiological Impact of Different Types of Osteoarthritis Education.
A study testing Pain Neuroscience Education and Standard Pain Education in people with Osteoarthritis and Chronic Pain, run by Lisa Carlesso at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Chronic Pain
- What is being tested?
- Pain Neuroscience Education and Standard Pain Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- 15 Aug 2024to 22 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- those who have received prior PNE
- those who have eye glasses prescription exceeding +/- 6 for spherical correction and/or +3 for astigmatism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Physiological Impact of Pain Neuroscience Education Versus Standard Education for Older Adults With Osteoarthritis
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.
Read the detailed 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
- Conditions
- Osteoarthritis, Chronic Pain
- Being tested
- Pain Neuroscience Education, Standard Pain Education
- Keywords
- Pain Neuroscience Education (PNE), Osteoarthritis, Autonomic Nervous System (ANS), Physiological responses, Biomedical education
- Medical subject headings
- Osteoarthritis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationOther
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 EducationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Pain neuroscience education | Experimental | The educational content will be presented to the participants at a computer station in the format of a website to navigate to simulate the experience and information that they may come across while browsing the internet for information about knee OA. The content will include 4 components, regardless of the education type. These components include knee osteoarthritis (OA)-related images, facts and myths, disease related concepts, and patient-doctor statements. The distinction between the two educational approaches lies in how information is presented. 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. After the educational content is delivered, the participants will be shown the content again and will be asked to talk aloud about each page that they were shown. Receives: Other: Pain Neuroscience Education |
| Biomedical education | Active comparator | 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.
After the educational content is delivered, the participants will be shown the content again and will be asked to talk aloud about each page that they were shown. Receives: Other: Standard Pain Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burden of the assessments
Burden of completing the physical tests and questionnaires (0 = no burden, 10 = most burden)
Measured: 1 week post-intervention
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
Measured: at 3 months
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)
Measured: 1 week post-intervention
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.
Measured: 1 week post-intervention
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.
Measured: 1 week post-intervention
Secondary outcomes (16)
Demographic information
age, sex, gender, education, marital status, race, height, and weight
Measured: At baseline
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)
Measured: Before and after the delivery of the intervention
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.
Measured: During the delivery of the intervention
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
Measured: Before and during the delivery of the intervention
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 alcohol, and physical exercise within 24 hours of the visit. Participants will also empty their bladders before the session. 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 lower left rib, the negative terminal to the right clavicle and grounding to the lower right rib. Heart Rate Variability (HRV) will be assessed using the Acqknowledge software, which is attached to the BioPac system (MP160, USA).
Measured: Before and during delivery of the intervention
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.
Measured: Before and during delivery of the intervention
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)
Measured: Before and after the delivery of the intervention
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)
Measured: Before and after the delivery of the intervention
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 (β=.30 to .41), physical functioning (β=.44 to .48), and psychological functioning (β=.36 to .37).(25)
Measured: Before and after the delivery of the intervention
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)
Measured: Before and after the delivery of the intervention
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 (α = .94) and validity in adults with knee OA(31).
Measured: Before the delivery of the intervention
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.
Measured: Before and after the delivery of the intervention
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).
Measured: Before and after the delivery of the intervention
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).
Measured: Before and after the delivery of the intervention
The Self-Administered Comorbidity Questionnaire (SCQ)
The self-administered comorbidity questionnaire (SCQ) is a highly effective tool for evaluating comorbid conditions in both clinical and health services research. The SCQ is brief, easy to understand, and can be completed by individuals without a medical background. It allows patients to indicate the severity of each comorbid condition and how it affects their daily functioning. The questionnaire includes 12 specific medical problems and 3 optional conditions. The SCQ shows modest correlations with a commonly used medical record-based comorbidity tool and with future health status and utilization.
Measured: Before the delivery of the intervention
Satisfaction with Information Quality
Satisfaction with information quality aims to capture respondents' views regarding the overall quality of information on a website using a 7-point Likert scale. Participants are prompted to assess their satisfaction levels across four dimensions: "Very dissatisfied" to "Very satisfied" (IQ1), "Very displeased" to "Very pleased" (IQ2), "Frustrated" to "Contented" (IQ3), and "Disappointed" to "Delighted" (IQ4). This comprehensive approach enables an understanding of users' perspectives on the quality of information available. This questionnaire demonstrated Adequate reliability. (Cronbach alpha>0.97)
Measured: After the delivery of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start15 Aug 2024
- Primary completion4 Mar 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisa Carlesso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lisa Carlesso, McMaster University
- Investigators
- Lisa Carlesso, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400329
- Sponsor's protocol ID
- HiREB-16902
- Acronym
- PNE
- Status last verified
- Sep 2025
- First submitted
- 25 Apr 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Louw 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 27351541Moseley L. Unraveling the barriers to reconceptualization of the problem in chronic pain: the actual and perceived ability of patients and health professionals to understand the neurophysiology. J Pain. 2003 May;4(4):184-9. doi: 10.1016/s1526-5900(03)00488-7.
PubMed 14622702Domenech J, Sanchez-Zuriaga D, Segura-Orti E, Espejo-Tort B, Lison JF. Impact of biomedical and biopsychosocial training sessions on the attitudes, beliefs, and recommendations of health care providers about low back pain: a randomised clinical trial. Pain. 2011 Nov;152(11):2557-2563. doi: 10.1016/j.pain.2011.07.023. Epub 2011 Sep 13.
PubMed 21917377Nissen N, Holm PM, Bricca A, Dideriksen M, Tang LH, Skou ST. Clinicians' beliefs and attitudes to physical activity and exercise therapy as treatment for knee and/or hip osteoarthritis: a scoping review. Osteoarthritis Cartilage. 2022 Feb;30(2):260-269. doi: 10.1016/j.joca.2021.11.008. Epub 2021 Nov 17.
PubMed 34800632Moseley GL, Butler DS. Fifteen Years of Explaining Pain: The Past, Present, and Future. J Pain. 2015 Sep;16(9):807-13. doi: 10.1016/j.jpain.2015.05.005. Epub 2015 Jun 5.
PubMed 26051220Bonatesta L, Ruiz-Cardenas JD, Fernandez-Azorin L, Rodriguez-Juan JJ. Pain Science Education Plus Exercise Therapy in Chronic Nonspecific Spinal Pain: A Systematic Review and Meta-analyses of Randomized Clinical Trials. J Pain. 2022 Apr;23(4):535-546. doi: 10.1016/j.jpain.2021.09.006. Epub 2021 Oct 20.
PubMed 34678468Ordonez-Mora LT, Morales-Osorio MA, Rosero ID. Effectiveness of Interventions Based on Pain Neuroscience Education on Pain and Psychosocial Variables for Osteoarthritis: A Systematic Review. Int J Environ Res Public Health. 2022 Feb 23;19(5):2559. doi: 10.3390/ijerph19052559.
PubMed 35270250Otis JD. Flor, H., & Turk, D. C. (2011)Chronic Pain: An Integrated Biobehavioral Approach Seattle: IASP Press. Cogn Behav Pract. 2013 Feb 1;20(1):117-8.
El-Badawy MA, El Mikkawy DM. Sympathetic Dysfunction in Patients With Chronic Low Back Pain and Failed Back Surgery Syndrome. Clin J Pain. 2016 Mar;32(3):226-31. doi: 10.1097/AJP.0000000000000250.
PubMed 25968450Bossenger NR, Lewis GN, Rice DA, Shepherd D. The autonomic and nociceptive response to acute exercise is impaired in people with knee osteoarthritis. Neurobiol Pain. 2023 Jan 19;13:100118. doi: 10.1016/j.ynpai.2023.100118. eCollection 2023 Jan-Jul.
PubMed 36711216Adlan AM, Paton JF, Lip GY, Kitas GD, Fisher JP. Increased sympathetic nerve activity and reduced cardiac baroreflex sensitivity in rheumatoid arthritis. J Physiol. 2017 Feb 1;595(3):967-981. doi: 10.1113/JP272944. Epub 2016 Oct 24.
PubMed 27561790Reyes del Paso GA, Garrido S, Pulgar A, Duschek S. Autonomic cardiovascular control and responses to experimental pain stimulation in fibromyalgia syndrome. J Psychosom Res. 2011 Feb;70(2):125-34. doi: 10.1016/j.jpsychores.2010.09.012. Epub 2010 Nov 18.
PubMed 21262414Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
PubMed 23295957Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.
PubMed 20053272NICE [Internet]. NICE; [cited 2024 Jan 29]. Osteoarthritis | NICE impact arthritis | Reviewing the impact of our guidance | Measuring the use of NICE guidance | Into practice | What we do | About. Available from: https://www.nice.org.uk/about/what-we-do/into-practice/measuring-the-use-of-nice-guidance/impact-of-our-guidance/nice-impact-arthritis/osteoarthritis
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Physiological Impact of Pain Neuroscience Education Versus Standard Education for Older Adults With Osteoarthritis
- ClinicalTrials.gov ID
- NCT06400329
- Acronym / sponsor ID
- PNE / HiREB-16902
- Conditions
- Osteoarthritis, Chronic Pain
- Keywords
- Pain Neuroscience Education (PNE), Osteoarthritis, Autonomic Nervous System (ANS), Physiological responses, Biomedical education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Lisa CarlessoUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 6 May 2024 (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.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain neuroscience education | Experimental | Other: Pain Neuroscience EducationThe educational content will be presented to the participants at a computer station in the format of a website to navigate to simulate the experience and information that they may come across while browsing the internet for information about knee OA. The content will include 4 components, regardless of the education type. These components include knee osteoarthritis (OA)-related images, facts and myths, disease related concepts, and patient-doctor statements. The distinction between the two educational approaches lies in how information is presented. 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. After the educational content is delivered, the participants will be shown the content again and will be asked to talk aloud about each page that they were shown. |
| Biomedical education | Active comparator | Other: Standard Pain EducationIn 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. After the educational content is delivered, the participants will be shown the content again and will be asked to talk aloud about each page that they were shown. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (2 listed)
- those who have received prior PNE
- those who have eye glasses prescription exceeding +/- 6 for spherical correction and/or +3 for astigmatism
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 Neuroscience EducationPNE 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 | Other | Pain neuroscience education |
| Standard Pain EducationIn 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 | Other | Biomedical education |
Primary outcome
Burden of the assessments
Time frame: 1 week post-intervention
Burden of completing the physical tests and questionnaires (0 = no burden, 10 = most burden)
feasibility outcomes (recruitment rate)
Time frame: 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
Feasibility outcomes (Educational content and format acceptability)
Time frame: 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)
Time frame: 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.
Feasibility outcomes (Scheduling of Lab assessments)
Time frame: 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.
16 secondary outcomes
Demographic information
Time frame: At baseline
Temporal Summation (TS)
Time frame: Before and after the delivery of the intervention
Eye Tracker
Time frame: During the delivery of the intervention
Galvanic Skin Response
Time frame: Before and during the delivery of the intervention
Heart Rate variability
Time frame: Before and during delivery of the intervention
Respiratory Rate
Time frame: Before and during delivery of the intervention
Chronic pain self-efficacy
Time frame: Before and after the delivery of the intervention
Anxiety symptoms
Time frame: Before and after the delivery of the intervention
Fear of movement
Time frame: Before and after the delivery of the intervention
Knee injury and outcomes
Time frame: Before and after the delivery of the intervention
eHEALS
Time frame: Before the delivery of the intervention
The Osteoarthritis Conceptualization Questionnaire
Time frame: Before and after the delivery of the intervention
The Intention to Exercise scale
Time frame: Before and after the delivery of the intervention
The surgery intention scale
Time frame: Before and after the delivery of the intervention
The Self-Administered Comorbidity Questionnaire (SCQ)
Time frame: Before the delivery of the intervention
Satisfaction with Information Quality
Time frame: After the delivery of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Background: 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.
- Background: PubMed 14622702Moseley L. Unraveling the barriers to reconceptualization of the problem in chronic pain: the actual and perceived ability of patients and health professionals to understand the neurophysiology. J Pain. 2003 May;4(4):184-9. doi: 10.1016/s1526-5900(03)00488-7.
- Background: PubMed 21917377Domenech J, Sanchez-Zuriaga D, Segura-Orti E, Espejo-Tort B, Lison JF. Impact of biomedical and biopsychosocial training sessions on the attitudes, beliefs, and recommendations of health care providers about low back pain: a randomised clinical trial. Pain. 2011 Nov;152(11):2557-2563. doi: 10.1016/j.pain.2011.07.023. Epub 2011 Sep 13.
- Background: PubMed 34800632Nissen N, Holm PM, Bricca A, Dideriksen M, Tang LH, Skou ST. Clinicians' beliefs and attitudes to physical activity and exercise therapy as treatment for knee and/or hip osteoarthritis: a scoping review. Osteoarthritis Cartilage. 2022 Feb;30(2):260-269. doi: 10.1016/j.joca.2021.11.008. Epub 2021 Nov 17.
- Background: PubMed 26051220Moseley GL, Butler DS. Fifteen Years of Explaining Pain: The Past, Present, and Future. J Pain. 2015 Sep;16(9):807-13. doi: 10.1016/j.jpain.2015.05.005. Epub 2015 Jun 5.
- Background: PubMed 34678468Bonatesta L, Ruiz-Cardenas JD, Fernandez-Azorin L, Rodriguez-Juan JJ. Pain Science Education Plus Exercise Therapy in Chronic Nonspecific Spinal Pain: A Systematic Review and Meta-analyses of Randomized Clinical Trials. J Pain. 2022 Apr;23(4):535-546. doi: 10.1016/j.jpain.2021.09.006. Epub 2021 Oct 20.
- Background: PubMed 35270250Ordonez-Mora LT, Morales-Osorio MA, Rosero ID. Effectiveness of Interventions Based on Pain Neuroscience Education on Pain and Psychosocial Variables for Osteoarthritis: A Systematic Review. Int J Environ Res Public Health. 2022 Feb 23;19(5):2559. doi: 10.3390/ijerph19052559.
- BackgroundOtis JD. Flor, H., & Turk, D. C. (2011)Chronic Pain: An Integrated Biobehavioral Approach Seattle: IASP Press. Cogn Behav Pract. 2013 Feb 1;20(1):117-8.
- Background: PubMed 25968450El-Badawy MA, El Mikkawy DM. Sympathetic Dysfunction in Patients With Chronic Low Back Pain and Failed Back Surgery Syndrome. Clin J Pain. 2016 Mar;32(3):226-31. doi: 10.1097/AJP.0000000000000250.
- Background: PubMed 36711216Bossenger NR, Lewis GN, Rice DA, Shepherd D. The autonomic and nociceptive response to acute exercise is impaired in people with knee osteoarthritis. Neurobiol Pain. 2023 Jan 19;13:100118. doi: 10.1016/j.ynpai.2023.100118. eCollection 2023 Jan-Jul.
- Background: PubMed 27561790Adlan AM, Paton JF, Lip GY, Kitas GD, Fisher JP. Increased sympathetic nerve activity and reduced cardiac baroreflex sensitivity in rheumatoid arthritis. J Physiol. 2017 Feb 1;595(3):967-981. doi: 10.1113/JP272944. Epub 2016 Oct 24.
- Background: PubMed 21262414Reyes del Paso GA, Garrido S, Pulgar A, Duschek S. Autonomic cardiovascular control and responses to experimental pain stimulation in fibromyalgia syndrome. J Psychosom Res. 2011 Feb;70(2):125-34. doi: 10.1016/j.jpsychores.2010.09.012. Epub 2010 Nov 18.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lisa Carlesso, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education and Standard Pain Education in people with Osteoarthritis and Chronic Pain, run by Lisa Carlesso at 1 site in Canada.
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: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burden of the assessments (time frame: 1 week post-intervention). The study lists 5 primary outcomes in all. 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 NCT06400329, which also lists 32 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 25 Sep 2025.