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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
Federal University of Espirito Santo
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 14, 2022
    Last Updated
    September 14, 2022
    Sponsor
    Federal University of Espirito Santo
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    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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