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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Musculoskeletal Pain
• Intervention / Treatment: Behavioral: Interdisciplinary Pain Education Program; Other: Conventional Physiotherapy 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 Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valéria Valim, PhD; Phone Number: +55 27 33157899; Email: val.valim@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; Interdisciplinary Pain Education Program and conventional physical therapy treatment	Behavioral: Interdisciplinary Pain Education Program; 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.; Other: Conventional Physiotherapy treatment; 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.
ACTIVE_COMPARATOR: Comparison group; Conventional physical therapy treatment	Other: Conventional Physiotherapy treatment; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of Espirito Santo

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (ACTUAL): September 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Health Education; Health-Related Quality Of Life; Self Efficacy; Functional Health Literacy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain
• Other Study ID Numbers: FUEspiritoSanto

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No