Effectiveness of an Interdisciplinary Pain Education Program in Public Health: a Pragmatic Clinical Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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his 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. Clinical characteristics of pain will be evaluated by multidimensional questionnaires, in addition to self-efficacy, quality of life, functional literacy and sociodemographic profile. Health professionals will be evaluated by an attitude towards pain inventory. It is expected to demonstrate the effectiveness of interdisciplinary pain education work in managing the biopsychosocial impacts of pain by promoting knowledge and self-management strategies in the care of this chronic condition. As it is a light and collective technology, it can reduce the burden of the disease and support public policy decision-making in the management of chronic pain in public health.

Official Title
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Effectiveness of an Interdisciplinary Pain Education Program in Public Health: a Pragmatic Clinical Trial

Conditions
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Musculoskeletal Pain

Intervention / Treatment
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* Behavioral: Interdisciplinary Pain Education Program
* Other: Conventional Physiotherapy treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a clinical picture of chronic musculoskeletal pain, aged over 18 years, being SUS users referred for Physiotherapy treatment. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Interdisciplinary Pain Education Program and conventional physical therapy treatment | Behavioral: Interdisciplinary Pain Education Program<br>* 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.<br>Other: Conventional Physiotherapy treatment<br>* 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.<br>|
| Active Comparator: Comparison group<br>Conventional physical therapy treatment | Other: Conventional Physiotherapy treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory | pain-related scores ranging from zero (did not interfere) to ten (completely interfered) | 2 weeks | 
| Brief Pain Inventory | pain-related scores ranging from zero (did not interfere) to ten (completely interfered) | 3 months | 
| EuroQol (EQ-5D-3L) | patient's quality of life through self-assessment in five dimensions: mobility; self-care; usual activities; pain/discomfort; anxiety / depression. Each dimension has 3 levels: no problems, some problems, extreme problems/disability | 2 weeks | 
| EuroQol (EQ-5D-3L) | patient's quality of life through self-assessment in five dimensions: mobility; self-care; usual activities; pain/discomfort; anxiety / depression. Each dimension has 3 levels: no problems, some problems, extreme problems/disability | 3 months | 
| Health Literacy Scale (HLS-14) | assesses the level of health literacy through fourteen questions on a five-point Likert scale, in three dimensions of literacy: functional and communicative with 5 items each, and critical with 4 items. | 2 weeks | 
| Health Literacy Scale (HLS-14) | assesses the level of health literacy through fourteen questions on a five-point Likert scale, in three dimensions of literacy: functional and communicative with 5 items each, and critical with 4 items. | 3 months | 
| Survey of Pain Attitudes-Professionals (IAD-Profissionais) | 20 items, covering 6 domains: emotion, control, disability, solicitude, medical cure and physical harm | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Education, Self Efficacy, Health-Related Quality Of Life, Functional Health Literacy