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

Not Applicable

Not yet recruiting

• Conditions: Musculoskeletal Pain
• Interventions: Behavioral: Interdisciplinary Pain Education Program; Other: Conventional Physiotherapy treatment

• Registration Number: NCT05544383
• Lead Sponsor: Federal University of Espirito Santo

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Last Update Submitted: 2022-09-14
• Study First Posted: 2022-09-16
• Last Update Posted: 2022-09-16
• Study Start: 2022-10-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Interdisciplinary Pain Education Program	Interdisciplinary Pain Education Program and conventional physical therapy treatment
Comparison group	Conventional Physiotherapy treatment	Conventional physical therapy treatment
Intervention group	Conventional Physiotherapy treatment	Interdisciplinary Pain Education Program and conventional physical therapy treatment

Primary Outcome Measures

Name	Time	Method
Pain Self-Efficacy Questionnaire	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Brief Pain Inventory	3 months	pain-related scores ranging from zero (did not interfere) to ten (completely interfered)
Health Literacy Scale (HLS-14)	3 months	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.
Survey of Pain Attitudes-Professionals (IAD-Profissionais)	1 day	20 items, covering 6 domains: emotion, control, disability, solicitude, medical cure and physical harm
EuroQol (EQ-5D-3L)	3 months	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