Clinical trial NCT05302180: Online Pain Education in Addition to Usual Care in Chronic Pain.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Musculoskeletal Pain
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: hybrid type III effectiveness-implementation randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline pain at 10 week of the intervention
timeFrame: baseline, 10 week
measure: Maintenance of pain at 6 months of the intervention
timeFrame: up to 6 months
Secondary outcomes:
measure: Change from baseline self-efficacy at 10 week of the intervention
timeFrame: baseline, 10 week
measure: Change from baseline function at 10 week of the intervention
timeFrame: baseline, 10 week
measure: Maintenance of function at 6 months of the intervention
timeFrame: up to 6 months
measure: Change from baseline quality of sleep at 10 week of the intervention
timeFrame: baseline, 10 week
measure: Maintenance of quality of sleep at 6 months of the intervention
timeFrame: up to 6 months
measure: Change from baseline physical activity at 10 week of the intervention
timeFrame: baseline, 10 week
measure: Maintenance of physical activity at 6 months of the intervention
timeFrame: up to 6 months
measure: Change from baseline health-related quality of life at 10 week of the intervention
timeFrame: baseline, 10 week
measure: Maintenance of health-related quality at 6 months of the intervention
timeFrame: up to 6 months
measure: Change from baseline prognostic and risk groups at 10 week of the intervention
timeFrame: baseline, 10 week
measure: Maintenance of prognostic and risk groups at 6 months of the intervention
timeFrame: up to 6 months
measure: Occurrence of adverse events up to 6 months of the intervention begging
timeFrame: 10 week; and up to 6 months
Other outcomes:
measure: Assessment of the intervention acceptability by the perspective of public health managers
timeFrame: through study completion, an average 24 months
measure: Assessment of the intervention acceptability by the perspective of participants
timeFrame: 10 week
measure: Assessment of the intervention appropriateness by the participants' perspective
timeFrame: 10 week
measure: Assessment of the intervention feasibility by the organization and individual providers
timeFrame: through study completion, an average 24 months
measure: Assessment of the intervention adoption
timeFrame: pre-intervention
measure: Assessment of the intervention fidelity by perspective of the specialist
timeFrame: through study completion, an average 24 months
measure: Assessment of the intervention fidelity by the adherence of participants during 10 week intervention
timeFrame: 10 week
measure: Maintenance of the intervention fidelity up to 6 months
timeFrame: up to 6 months
measure: Assessment of the intervention penetration
timeFrame: through study completion, an average 24 months
measure: Economic evaluation of the intervention
timeFrame: baseline; up to 6 months
measure: Assessment of the intervention sustainability
timeFrame: through study completion, an average 24 months
Locations:
city: Guarapuava
country: Brazil
facility: Universidade Estadual do Centro-Oeste
state: Paraná
Study officials:
References: