Effectiveness of an Interdisciplinary Pain Education Program in Public Health: a Pragmatic Clinical Trial
Primary Purpose
Musculoskeletal Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interdisciplinary Pain Education Program
Conventional Physiotherapy treatment
Sponsored by

About this trial
This is an interventional treatment trial for Musculoskeletal Pain focused on measuring Health Education, Self Efficacy, Health-Related Quality Of Life, Functional Health Literacy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Comparison group
Arm Description
Interdisciplinary Pain Education Program and conventional physical therapy treatment
Conventional physical therapy treatment
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Brief Pain Inventory
pain-related scores ranging from zero (did not interfere) to ten (completely interfered)
Brief Pain Inventory
pain-related scores ranging from zero (did not interfere) to ten (completely interfered)
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
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
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.
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.
Survey of Pain Attitudes-Professionals (IAD-Profissionais)
20 items, covering 6 domains: emotion, control, disability, solicitude, medical cure and physical harm
Full Information
NCT ID
NCT05544383
First Posted
September 14, 2022
Last Updated
September 14, 2022
Sponsor
Federal University of Espirito Santo
1. Study Identification
Unique Protocol Identification Number
NCT05544383
Brief Title
Effectiveness of an Interdisciplinary Pain Education Program in Public Health: a Pragmatic Clinical Trial
Official Title
Effectiveness of an Interdisciplinary Pain Education Program in Public Health: a Pragmatic Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Espirito Santo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
Keywords
Health Education, Self Efficacy, Health-Related Quality Of Life, Functional Health Literacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Interdisciplinary Pain Education Program and conventional physical therapy treatment
Arm Title
Comparison group
Arm Type
Active Comparator
Arm Description
Conventional physical therapy treatment
Intervention Type
Behavioral
Intervention Name(s)
Interdisciplinary Pain Education Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Self-Efficacy Questionnaire
Description
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.
Time Frame
2 weeks
Title
Pain Self-Efficacy Questionnaire
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Brief Pain Inventory
Description
pain-related scores ranging from zero (did not interfere) to ten (completely interfered)
Time Frame
2 weeks
Title
Brief Pain Inventory
Description
pain-related scores ranging from zero (did not interfere) to ten (completely interfered)
Time Frame
3 months
Title
EuroQol (EQ-5D-3L)
Description
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
Time Frame
2 weeks
Title
EuroQol (EQ-5D-3L)
Description
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
Time Frame
3 months
Title
Health Literacy Scale (HLS-14)
Description
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.
Time Frame
2 weeks
Title
Health Literacy Scale (HLS-14)
Description
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.
Time Frame
3 months
Title
Survey of Pain Attitudes-Professionals (IAD-Profissionais)
Description
20 items, covering 6 domains: emotion, control, disability, solicitude, medical cure and physical harm
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valéria Valim, PhD
Phone
+55 27 33157899
Email
val.valim@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valéria Valim, PhD
Organizational Affiliation
Federal University of Espirito Santo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of an Interdisciplinary Pain Education Program in Public Health: a Pragmatic Clinical Trial
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