NCT05544383

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

September 14, 2022

Last Update Submit

September 14, 2022

Conditions

Keywords

Health EducationSelf EfficacyHealth-Related Quality Of LifeFunctional Health Literacy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Brief Pain Inventory

    2 weeks

  • Brief Pain Inventory

    3 months

  • EuroQol (EQ-5D-3L)

    2 weeks

  • EuroQol (EQ-5D-3L)

    3 months

  • Health Literacy Scale (HLS-14)

    2 weeks

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Interdisciplinary Pain Education Program and conventional physical therapy treatment

Behavioral: Interdisciplinary Pain Education ProgramOther: Conventional Physiotherapy treatment

Comparison group

ACTIVE COMPARATOR

Conventional physical therapy treatment

Other: Conventional Physiotherapy treatment

Interventions

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 group

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.

Comparison groupIntervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a clinical picture of chronic musculoskeletal pain, aged over 18 years, being SUS users referred for Physiotherapy treatment.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Musculoskeletal PainHealth Education

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Valéria Valim, PhD

    Federal University of Espirito Santo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valéria Valim, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 16, 2022

Study Start

October 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 30, 2023

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share