Online Pain Education in Addition to Usual Care in Chronic Pain.

Study Overview
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Brief Summary
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The lack of pain specialists limits users' access to non-pharmacological therapeutic pain control strategies. In this context, digital health programs can reduce the inequity of access to interventions, contribute to the self-management of chronic musculoskeletal conditions, reduce the burden on primary care and can help to reorganize the flow of referral of individuals in the health care network. The aim of this study will be to analyze the implementation and health outcomes of three online pain neuroscience education strategies in individuals with chronic musculoskeletal pain. This is a hybrid type III effectiveness-implementation randomized controlled trial. Individuals with ≥18 years old with chronic musculoskeletal pain will be recruited from primary health care in the city of Guarapuava/PR/Brazil and referred to the health care network for conventional physical therapy in addition to the online pain neuroscience education program (EducaDor). The EducaDor program will be delivered in 3 modalities: 1) synchronous online; 2) asynchronous videos; 3) Interactive e-book. The implementation outcomes evaluated will be: acceptability, appropriateness, feasibility, adoption, fidelity, penetration, sustainability and costs; and health outcomes will include: pain, functionality, quality of life, sleep, physical activity, self-efficacy, adverse effects, prognostic and risk groups. The evaluations will be done at baseline, after the end of the interventions and follow-up of 6 months.

Detailed Description
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Systematic reviews have demonstrated the efficacy of pain neuroscience education in the treatment of adult individuals with chronic musculoskeletal pain in reducing pain, anxiety, and depression; and increased of knowledge about pain, functionality and physical performance. The literature demonstrates moderate quality of evidence of pain neuroscience education in addition to usual physical therapy intervention in short-term with a weighted mean difference of 1.3 points for pain and 3.94 points for disability. Previous systematic reviews also suggest that pain neuroscience education alongside to usual physical therapy care or exercise-based treatments can be considered cost-effective compared to usual care alone. Despite the large evidence for treatment of chronic pain, generally these evidence-based strategies are inadequately applied in practice by public health providers, inadequately integrated into lifestyle behaviors by health users and featured in health policy and health service delivery at a disproportionate level with the burden of disease. Another point, is that most of this available evidence is derived largely from research of high-income economies and reflected in clinical practice guidelines and policies targeted towards high-income settings. So, strategies to translate this evidence into policy and practice in low- and middle-income settings remain sparse. Hence, implementation research to determine the most acceptable, effective and sustainable health strategies to bring the chronic pain clinical practice guidelines into policy and practice in low- and middle-income countries is urgently needed. Thus, the implementation of an online pain neuroscience education service in the health care network of Brazilian Unified Health System (SUS) articulated with primary health care could provide coordinated and consistent care to the needs of individuals with chronic pain, with appropriate reference to specialists. The purpose of this study is to conduct a hybrid type III effectiveness-implementation randomized controlled trial with the following objectives: (1) to assess the effects of three implementation strategies of an online pain neuroscience education service in the public health system of Guarapuava city, Parana, Brazil; (2) to compare the effectiveness and cost-effectiveness of the three implementation strategies of online pain education.

Official Title
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Online Pain Education in Addition to Usual Care in Individuals With Chronic Musculoskeletal Pain: Protocol for a Hybrid Type III Randomized Controlled Trial.

Conditions
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Chronic Pain, Musculoskeletal Pain

Intervention / Treatment
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* Other: Pain neuroscience education
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individuals that report musculoskeletal pain in the last 3 months; can read and write in Portuguese language; have smartphone, tablet or computer with internet access. Participants will be included in the study after agreeing and signing the Informed Consent Form (ICF). Exclusion Criteria: There will be no exclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: hybrid type III effectiveness-implementation randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synchronous online group<br>The synchronous online pain neuroscience education program (EducaDor program) will be held in groups at until 12 participants, at 10 weekly synchronous meetings on the Whereby® platform.The professional will conduct each synchronous meeting with dialogued exhibition class using multimedia material shared on the computer screen | Other: Pain neuroscience education<br>* The online pain neuroscience education program will be based on the model proposed by the Pain Research Group, available in http://pesquisaemdor.com.br, which presents the Path of Recovery. In our program we will hold 10 meetings: (1) conversation with the group, (2) acceptance and pain education, (3) continuation about pain education, (4) sleep hygiene, (5) pharmacological assistance, (6) recognizing stress and negative emotions, (7) increasing positive coping in lifestyle, (8) exercises, (9) communication, and (10) prevention of recurrence. The program will be offered by synchronous meetings; asynchronous (videos) and e-book.<br>Other: Usual care<br>* All participants will receive usual care in one of the five physiotherapy clinics accredited to SUS, according to availability of scheduling in the services. The usual care consists of 10 sessions of physical therapy, that is mainly composed by kinesiotherapy and electrothermophototherapy.<br>|
| Experimental: Asynchronous group<br>Participants allocated in the asynchronous group will receive the interactive e-book at the beginning of the program and ten videos (one per week) with the same topics of synchronous online EducaDor program sent on their smartphone devices and e-mail, in addition to usual care. Before receiving the materials, users will participate in an individual or group synchronous meeting of up to 12 participants on the Whereby® platform to receive a guidance for the use of interactive e-book and access to videos over the 10 weeks. The videos were previously developed and tested in another clinical trial. | Other: Pain neuroscience education<br>* The online pain neuroscience education program will be based on the model proposed by the Pain Research Group, available in http://pesquisaemdor.com.br, which presents the Path of Recovery. In our program we will hold 10 meetings: (1) conversation with the group, (2) acceptance and pain education, (3) continuation about pain education, (4) sleep hygiene, (5) pharmacological assistance, (6) recognizing stress and negative emotions, (7) increasing positive coping in lifestyle, (8) exercises, (9) communication, and (10) prevention of recurrence. The program will be offered by synchronous meetings; asynchronous (videos) and e-book.<br>Other: Usual care<br>* All participants will receive usual care in one of the five physiotherapy clinics accredited to SUS, according to availability of scheduling in the services. The usual care consists of 10 sessions of physical therapy, that is mainly composed by kinesiotherapy and electrothermophototherapy.<br>|
| Active Comparator: E-book group<br>Participants allocated to this group will receive the interactive e-book of EducaDor program in their smartphone devices and e-mail, in addition to usual care. Before receiving the e-book, the users will also participate in an individual or group synchronous meeting of up to 12 participants on the Whereby® platform to receive a guidance for the use of interactive e-book over the 10 weeks. | Other: Pain neuroscience education<br>* The online pain neuroscience education program will be based on the model proposed by the Pain Research Group, available in http://pesquisaemdor.com.br, which presents the Path of Recovery. In our program we will hold 10 meetings: (1) conversation with the group, (2) acceptance and pain education, (3) continuation about pain education, (4) sleep hygiene, (5) pharmacological assistance, (6) recognizing stress and negative emotions, (7) increasing positive coping in lifestyle, (8) exercises, (9) communication, and (10) prevention of recurrence. The program will be offered by synchronous meetings; asynchronous (videos) and e-book.<br>Other: Usual care<br>* All participants will receive usual care in one of the five physiotherapy clinics accredited to SUS, according to availability of scheduling in the services. The usual care consists of 10 sessions of physical therapy, that is mainly composed by kinesiotherapy and electrothermophototherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline pain at 10 week of the intervention | numerical rating scale (NRS) of 11 points, ranging from 0 (no pain) to 10 points (the worst possible pain) points | baseline, 10 week | 
| Maintenance of pain at 6 months of the intervention | numerical rating scale (NRS) of 11 points, ranging from 0 (no pain) to 10 points (the worst possible pain) points | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline self-efficacy at 10 week of the intervention | Chronic Pain Self-Efficacy Scale (CPSS)(63), with 22 items of individual's beliefs, whose items are divided into three factors: (1) self-efficacy for pain control (AED), (2) self-efficacy for other symptoms (AES) and (3) self-efficacy for physical function (AEF). It is possible to obtain a score for each factor (score ranging from 10 to 100), and the sum of all factors that ranges from 30 to 300 points | baseline, 10 week | 
| Change from baseline function at 10 week of the intervention | The Patient Specific Functional Scale (PSFS-Br) will be used. The participant appoint 3 to 5 important activities which they have greater difficulty due to their condition and then graduates the level of their difficulty on a 11 points scale, ranging 0 (inability to perform the activity) to 10 (capable of performing the activity at the same level as before the injury or problem) | baseline, 10 week | 
| Maintenance of function at 6 months of the intervention | The Patient Specific Functional Scale (PSFS-Br) will be used. The participant appoint 3 to 5 important activities which they have greater difficulty due to their condition and then graduates the level of their difficulty on a 11 points scale, ranging 0 (inability to perform the activity) to 10 (capable of performing the activity at the same level as before the injury or problem) | up to 6 months | 
| Change from baseline quality of sleep at 10 week of the intervention | Quality of sleep will be evaluated by a self-report of sleep quality in the last 7 days on a scale of 0 to 100 points (0 - worst sleep quality; 100 - better sleep quality). | baseline, 10 week | 
| Maintenance of quality of sleep at 6 months of the intervention | Quality of sleep will be evaluated by a self-report of sleep quality in the last 7 days on a scale of 0 to 100 points (0 - worst sleep quality; 100 - better sleep quality). | up to 6 months | 
| Change from baseline physical activity at 10 week of the intervention | Physical activity will be evaluated by a self-report of the type, duration and intensity of physical activity performed in the last 7 days | baseline, 10 week | 
| Maintenance of physical activity at 6 months of the intervention | Physical activity will be evaluated by a self-report of the type, duration and intensity of physical activity performed in the last 7 days | up to 6 months | 
| Change from baseline health-related quality of life at 10 week of the intervention | Health-related quality of life: will be evaluated using the EQ-5D-3L questionnaire, which is composed of a descriptive model with five health domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). | baseline, 10 week | 
| Maintenance of health-related quality at 6 months of the intervention | Health-related quality of life: will be evaluated using the EQ-5D-3L questionnaire, which is composed of a descriptive model with five health domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). | up to 6 months | 
| Change from baseline prognostic and risk groups at 10 week of the intervention | Prognostic and risk groups will be evaluated by the Keele STarT MSK Took(67). The tool contains 10 items (ranged from 0 to 12 points each) that once scored can place patients into three categories based on their risk of a poor outcome in low risk (0-4 points), medium risk (5-8 points), and high risk (9-12 points) | baseline, 10 week | 
| Maintenance of prognostic and risk groups at 6 months of the intervention | Prognostic and risk groups will be evaluated by the Keele STarT MSK Took(67). The tool contains 10 items (ranged from 0 to 12 points each) that once scored can place patients into three categories based on their risk of a poor outcome in low risk (0-4 points), medium risk (5-8 points), and high risk (9-12 points) | up to 6 months | 
| Occurrence of adverse events up to 6 months of the intervention begging | Adverse events: will be analyzed by recording the number and type of adverse effects that occurred during the intervention period. | 10 week; and up to 6 months |