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

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ClinicalTrials.gov Identifier: NCT05544383
Recruitment Status : Not yet recruiting
First Posted : September 16, 2022
Last Update Posted : September 16, 2022
Sponsor:
Information provided by (Responsible Party):
Valéria Valim, Federal University of Espirito Santo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Musculoskeletal Pain Behavioral: Interdisciplinary Pain Education Program Other: Conventional Physiotherapy treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of an Interdisciplinary Pain Education Program in Public Health: a Pragmatic Clinical Trial
Estimated Study Start Date : October 1, 2022
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 30, 2023
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Pain Self-Efficacy Questionnaire [ Time Frame: 2 weeks ]
    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. Pain Self-Efficacy Questionnaire [ Time Frame: 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 :
  1. Brief Pain Inventory [ Time Frame: 2 weeks ]
    pain-related scores ranging from zero (did not interfere) to ten (completely interfered)

  2. Brief Pain Inventory [ Time Frame: 3 months ]
    pain-related scores ranging from zero (did not interfere) to ten (completely interfered)

  3. EuroQol (EQ-5D-3L) [ Time Frame: 2 weeks ]
    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

  4. EuroQol (EQ-5D-3L) [ Time Frame: 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

  5. Health Literacy Scale (HLS-14) [ Time Frame: 2 weeks ]
    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.

  6. Health Literacy Scale (HLS-14) [ Time Frame: 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.

  7. Survey of Pain Attitudes-Professionals (IAD-Profissionais) [ Time Frame: 1 day ]
    20 items, covering 6 domains: emotion, control, disability, solicitude, medical cure and physical harm


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05544383


Contacts
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Contact: Valéria Valim, PhD +55 27 33157899 val.valim@gmail.com

Sponsors and Collaborators
Federal University of Espirito Santo
Investigators
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Principal Investigator: Valéria Valim, PhD Federal University of Espirito Santo
More Information
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Responsible Party: Valéria Valim, Professor, Federal University of Espirito Santo
ClinicalTrials.gov Identifier: NCT05544383    
Other Study ID Numbers: FUEspiritoSanto
First Posted: September 16, 2022    Key Record Dates
Last Update Posted: September 16, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Valéria Valim, Federal University of Espirito Santo:
Health Education
Self Efficacy
Health-Related Quality Of Life
Functional Health Literacy
Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations