Effectiveness of an Interdisciplinary Pain Education Program in Public Health: a Pragmatic Clinical Trial
1 other identifier
interventional
108
0 countries
N/A
Brief Summary
The objective of this study is to evaluate the effectiveness of an interdisciplinary pain education program in improving self-efficacy and promoting quality of life in patients with chronic musculoskeletal pain in public health. This is a pragmatic clinical trial carried out with patients referred to the Physical Therapy sector of a municipality who will be allocated in an interdisciplinary pain education intervention group or a comparison group of conventional physical therapy treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2022
CompletedFirst Posted
Study publicly available on registry
September 16, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedSeptember 16, 2022
September 1, 2022
8 months
September 14, 2022
September 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pain Self-Efficacy Questionnaire
The total score is calculated by adding the scores for each of the 10 items, resulting in a value ranging from 0 to 60, with higher scores reflecting stronger self-efficacy beliefs.
2 weeks
Pain Self-Efficacy Questionnaire
The total score is calculated by adding the scores for each of the 10 items, resulting in a value ranging from 0 to 60, with higher scores reflecting stronger self-efficacy beliefs.
3 months
Secondary Outcomes (7)
Brief Pain Inventory
2 weeks
Brief Pain Inventory
3 months
EuroQol (EQ-5D-3L)
2 weeks
EuroQol (EQ-5D-3L)
3 months
Health Literacy Scale (HLS-14)
2 weeks
- +2 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALInterdisciplinary Pain Education Program and conventional physical therapy treatment
Comparison group
ACTIVE COMPARATORConventional physical therapy treatment
Interventions
It is an operative group model, with the objective of promoting education in pain, where the patient occupies an active and central space in the learning process, with work focused on the dysfunctional beliefs of chronic pain, performing programmed tasks to promote autonomy in activities daily life and behavior change. The group works with one meeting per week, during the routine opening hours of the clinic, with each day a theme of a professional area being addressed, totaling 5 meetings, lasting approximately two hours.
The therapeutic approach consists of rehabilitation methods and techniques, with the aim of restoring, developing and conserving the patient's physical capacity and functionality, including manual therapy and kinesiotherapy, in addition to the use of resources such as electrotherapy, thermotherapy and auriculotherapy. The treatment is performed at the Physiotherapy outpatient clinic, twice a week, with an average duration of 45 minutes, for a period that lasts an average of 10 sessions in clinical cases of chronic musculoskeletal pain.
Eligibility Criteria
You may qualify if:
- Patients with a clinical picture of chronic musculoskeletal pain, aged over 18 years, being SUS users referred for Physiotherapy treatment.
You may not qualify if:
- Patients with a clinical picture of acute pain, post-traumatic or post-surgical pain, cancer pain and neuropathic pain, as well as those with autoimmune diseases. Patients with cognitive problems who cannot understand and respond to the questionnaires and who also have other physical disabilities unrelated to the chronic pain condition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valéria Valim, PhD
Federal University of Espirito Santo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 14, 2022
First Posted
September 16, 2022
Study Start
October 1, 2022
Primary Completion
June 1, 2023
Study Completion
June 30, 2023
Last Updated
September 16, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share