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

NCT ID: NCT05302180

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-27

Study Completion Date

2025-03-31

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.

Conditions

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Chronic Pain Musculoskeletal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

hybrid type III effectiveness-implementation randomized controlled trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators
The outcomes' evaluators will be blind about the allocation of participants in the study groups and they will be questioned at the end of the study on which group they believe that each participant was allocated in order to evaluate the success/failure of blinding. Due to the nature of the interventions it will not be possible to blind the participants and researchers responsible for the interventions.

Study Groups

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Synchronous online group

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

Group Type EXPERIMENTAL

Pain neuroscience education

Intervention Type OTHER

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.

Usual care

Intervention Type OTHER

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.

Asynchronous group

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.

Group Type EXPERIMENTAL

Pain neuroscience education

Intervention Type OTHER

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.

Usual care

Intervention Type OTHER

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.

E-book group

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.

Group Type ACTIVE_COMPARATOR

Pain neuroscience education

Intervention Type OTHER

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.

Usual care

Intervention Type OTHER

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.

Interventions

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Pain neuroscience education

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.

Intervention Type OTHER

Usual care

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. individuals that report musculoskeletal pain in the last 3 months;
2. can read and write in Portuguese language;
3. have smartphone, tablet or computer with internet access.
4. Participants will be included in the study after agreeing and signing the Informed Consent Form (ICF).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Cidade de Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Dr Bruno Saragiotto

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidade Estadual do Centro-Oeste

Guarapuava, Paraná, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Marina Baroni, Ms.

Role: CONTACT

Phone: +55(42)999446621

Email: [email protected]

Facility Contacts

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Marina P Baroni

Role: primary

References

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Baroni MP, Hespanhol L, Miyamoto GC, Daniel CR, Fernandes LG, Dos Reis FJJ, Pate JW, Saragiotto BT. Implementation of an online pain science education for chronic musculoskeletal pain in Brazilian public health system: protocol for a hybrid type III randomised controlled trial with economic evaluation. BMC Musculoskelet Disord. 2023 Apr 10;24(1):277. doi: 10.1186/s12891-023-06360-7.

Reference Type DERIVED
PMID: 37038146 (View on PubMed)

Other Identifiers

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11975019.0.0000.0106

Identifier Type: -

Identifier Source: org_study_id