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

Chronic Pain Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05302180
• Other study ID #: 11975019.0.0000.0106
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2022
• Est. completion date: March 2025

Study information

• Verified date: December 2022
• Source: Universidade Cidade de Sao Paulo
• Contact: Marina Baroni, Ms.
• Phone: +55(42)999446621
• Email: marinapegoraro[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 249
• Est. completion date: March 2025
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Exclusion Criteria:

There will be no exclusion criteria

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Estadual do Centro-Oeste	Guarapuava	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of the intervention acceptability by the perspective of public health managers	will be analyzed from the perspective of public health managers through focus group interview, and the Acceptability of Intervention Measure (AIM) will be used.	through study completion, an average 24 months
Other	Assessment of the intervention acceptability by the perspective of participants	will be analyzed from the perspective of participants by individual qualitative interview about satisfaction with the intervention and by a numerical scale from 0 to 100 of how satisfied they were with participation in the intervention. The Acceptability of intervention measure (AIM) will be used.	10 week
Other	Assessment of the intervention appropriateness by the participants' perspective	Appropriateness will be analyzed from the participant's perspective regarding the perception of appropriateness of each component EducaDor program for their health condition through an adapted questionnaire used by Liao et al (2020). This questionnaire will assess the degree to which participants agree with a series of statements about the intervention, on a likert scale ranging from 1 (totally disagree) to 4 (totally agree). An individual qualitative interview ill also be conducted with EducaDor program's participants in order to identify the barriers and facilitators of the proposed interventions. The Intervention appropriateness measure (IAM) will also be used.	10 week
Other	Assessment of the intervention feasibility by the organization and individual providers	Feasibility will be evaluated from the perspective of the organization and individual providers through a focus group interview. The Feasibility intervention measure (FIM) will be used.	through study completion, an average 24 months
Other	Assessment of the intervention adoption	Adoption will be analyzed by the percentage of acceptance of public health users to participate in EducaDor program referred from primary health care. Those public health users that refuse to participate, during telephone contact will be done an individual qualitative interview to identify barriers to engagement to EducaDor program.	pre-intervention
Other	Assessment of the intervention fidelity by perspective of the specialist	Fidelity will be evaluated by an independent pain specialist, who will randomly select 10% of the recorded meetings and evaluate them in relation to the fidelity of the intervention manuals with the content and quality of the meetings in a qualitative individual interview.	through study completion, an average 24 months
Other	Assessment of the intervention fidelity by the adherence of participants during 10 week intervention	The adherence of participants with the EducaDor program will be measured by the frequency rate in synchronous meetings; self-report of performance of proposed homework on a numerical scale from 0 to 10 during the intervention period; and by exercise adherence scale.	10 week
Other	Maintenance of the intervention fidelity up to 6 months	The adherence of participants with the EducaDor program will be measured by the frequency rate in synchronous meetings; self-report of performance of proposed homework on a numerical scale from 0 to 10 during the intervention period; and by exercise adherence scale.	up to 6 months
Other	Assessment of the intervention penetration	Penetration will be analyzed descriptively from the rate of public health users referred from each Primary Health Care unit.	through study completion, an average 24 months
Other	Economic evaluation of the intervention	Economic evaluation will be analyzed from society perspective in a time horizon of 6 months (after the end of interventions and 6-month follow-up). The costs of intervention will be determined by maintenance and support technology costs, costs of monitoring data and staff, costs of training health professionals and project management, number and duration of phone calls and number of text messages sent to participants. The total costs of society will be estimated from the public and private health care costs, if possible (prescribed drugs, medical consultations, physical therapy care, visits to specialists, diagnostic exams, emergency services and hospitalization), patients costs (unprescribed drugs, complementary costs and transportation costs), and cmosts with loss of productivity (absenteeism and presenteeism) collected through a daily cost.	baseline; up to 6 months
Other	Assessment of the intervention sustainability	Sustainability will be evaluated by a focus group interview with public health managers after presentation the results of the study to discuss the maintenance of the EducaDor program; and by response rate of synchronous group users and reasons for discontinuity the program through an individual qualitative interview	through study completion, an average 24 months
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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