Chronic PainNCT05302180
Online Pain Education in Addition to Usual Care in Chronic Pain.
A study testing Pain neuroscience education in people with Chronic Pain and Musculoskeletal Pain, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Musculoskeletal Pain
- What is being tested?
- Pain neuroscience education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Oct 2022to Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- There will be no exclusion criteria
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Estadual do Centro-Oeste
Guarapuava, Paraná, 85.065-580
Marina P Baroni, +55(42)999446621, marinapegoraro@hotmail.com
About this study
Official title: Online Pain Education in Addition to Usual Care in Individuals With Chronic Musculoskeletal Pain: Protocol for a Hybrid Type III Randomized Controlled Trial.
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.
Read the detailed description
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
- Chronic Pain, Musculoskeletal Pain
- Being tested
- Pain neuroscience education, Usual care
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience educationOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Synchronous online group | Experimental | 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 Receives: Other: Pain neuroscience education; Other: Usual care |
| Asynchronous group | Experimental | 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. Receives: Other: Pain neuroscience education; Other: Usual care |
| E-book group | Active comparator | 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. Receives: Other: Pain neuroscience education; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 6 months
Secondary outcomes (12)
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
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 10 week; and up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start27 Oct 2022
- Primary completionDec 2023 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- hybrid type III effectiveness-implementation randomized controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 249 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Bruno Saragiotto, Universidade Cidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302180
- Sponsor's protocol ID
- 11975019.0.0000.0106
- Status last verified
- Dec 2022
- First submitted
- 15 Feb 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37038146
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Pain Education in Addition to Usual Care in Individuals With Chronic Musculoskeletal Pain: Protocol for a Hybrid Type III Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05302180
- Acronym / sponsor ID
- 11975019.0.0000.0106
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 249 participants (estimated)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 31 Mar 2022 (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.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- hybrid type III effectiveness-implementation randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Synchronous online group | Experimental | Other: Pain neuroscience education, Other: Usual careThe 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 |
| Asynchronous group | Experimental | Other: Pain neuroscience education, Other: Usual careParticipants 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. |
| E-book group | Active comparator | Other: Pain neuroscience education, Other: Usual careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- There will be no exclusion criteria
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 educationThe 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. | Other | Asynchronous group, E-book group, Synchronous online group |
| Usual careAll 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. | Other | Asynchronous group, E-book group, Synchronous online group |
Primary outcome
Change from baseline pain at 10 week of the intervention
Time frame: baseline, 10 week
numerical rating scale (NRS) of 11 points, ranging from 0 (no pain) to 10 points (the worst possible pain) points
Maintenance of pain at 6 months of the intervention
Time frame: up to 6 months
numerical rating scale (NRS) of 11 points, ranging from 0 (no pain) to 10 points (the worst possible pain) points
12 secondary outcomes
Change from baseline self-efficacy at 10 week of the intervention
Time frame: baseline, 10 week
Change from baseline function at 10 week of the intervention
Time frame: baseline, 10 week
Maintenance of function at 6 months of the intervention
Time frame: up to 6 months
Change from baseline quality of sleep at 10 week of the intervention
Time frame: baseline, 10 week
Maintenance of quality of sleep at 6 months of the intervention
Time frame: up to 6 months
Change from baseline physical activity at 10 week of the intervention
Time frame: baseline, 10 week
Maintenance of physical activity at 6 months of the intervention
Time frame: up to 6 months
Change from baseline health-related quality of life at 10 week of the intervention
Time frame: baseline, 10 week
Maintenance of health-related quality at 6 months of the intervention
Time frame: up to 6 months
Change from baseline prognostic and risk groups at 10 week of the intervention
Time frame: baseline, 10 week
Maintenance of prognostic and risk groups at 6 months of the intervention
Time frame: up to 6 months
Occurrence of adverse events up to 6 months of the intervention begging
Time frame: 10 week; and up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Derived from this study: PubMed 37038146Baroni 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.
- 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.
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 in people with Chronic Pain and Musculoskeletal Pain, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Dec 2022. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Baroni, Ms. (+55(42)999446621, marinapegoraro@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain at 10 week of the intervention (time frame: baseline, 10 week). The study lists 2 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 NCT05302180, which also lists 1 linked publication.
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 21 Dec 2022.