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

Musculoskeletal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05544383
• Other study ID #: FUEspiritoSanto
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2022
• Source: Federal University of Espirito Santo
• Contact: Valéria Valim, PhD
• Phone: +55 27 33157899
• Email: val.valim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 108
• Est. completion date: June 30, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Pain

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Espirito Santo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Brief Pain Inventory	pain-related scores ranging from zero (did not interfere) to ten (completely interfered)	2 weeks
Secondary	Brief Pain Inventory	pain-related scores ranging from zero (did not interfere) to ten (completely interfered)	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Survey of Pain Attitudes-Professionals (IAD-Profissionais)	20 items, covering 6 domains: emotion, control, disability, solicitude, medical cure and physical harm	1 day