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

NCT05302180 | Unknown

• 1 other identifier: 11975019.0.0000.0106
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Change from baseline self-efficacy at 10 week of the intervention

  baseline, 10 week

• Change from baseline function at 10 week of the intervention

  baseline, 10 week

• Maintenance of function at 6 months of the intervention

  up to 6 months

• Change from baseline quality of sleep at 10 week of the intervention

  baseline, 10 week

• Maintenance of quality of sleep at 6 months of the intervention

  up to 6 months

Other Outcomes (11)

• Assessment of the intervention acceptability by the perspective of public health managers

  through study completion, an average 24 months

• Assessment of the intervention acceptability by the perspective of participants

  10 week

• Assessment of the intervention appropriateness by the participants' perspective

  10 week

Study Arms (3)

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

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.

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.

Other: Pain neuroscience education; Other: Usual care

Interventions

Pain neuroscience education 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.

Asynchronous group; E-book group; Synchronous online group

Usual care 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; E-book group; Synchronous online group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Universidade Cidade de Sao Paulo: lead

Study Sites (1)

Universidade Estadual do Centro-Oeste

Guarapuava, Paraná, 85.065-580, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 37038146 DERIVED

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Central Study Contacts

Marina Baroni, Ms.

CONTACT

+55(42)999446621; marinapegoraro@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Model Details: hybrid type III effectiveness-implementation randomized controlled trial

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 31, 2022
• Study Start: October 27, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2025
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)