NCT05661968

Brief Summary

The goal of this clinical trial is to investigate the efficacy of an online educational program for physical therapists to change back pain beliefs. The main questions it aims to answer are: \- What is the effect of an online educational program to change beliefs about the management of back pain in physical therapists? A total of 106 physical therapists will be recruited for this study. Participants will be randomized into two groups: intervention and control groups. The intervention group will receive a 6-week online educational program including recommendations from international clinical practice guidelines for the management of back pain. The control group will not receive any intervention. The outcomes of this trial include beliefs about management of back pain and imaging exams and will be assessed at baseline and 6 weeks after randomization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

December 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

December 14, 2022

Last Update Submit

July 28, 2023

Conditions

Low Back Pain

Keywords

Low back painOnline educational programBeliefsPhysical Therapists

Outcome Measures

Primary Outcomes (1)

  • Modified Back Belief Questionnaire

    This questionnaire consists of 25 items assessing the following aspects: low back pain outcomes at work and patients' social life, treatment (including medication, surgical procedures, alternative treatments), low back pain prognosis, causes of low back pain and diagnostic methods. The score of each item follows a Likert scale ranging from 1 to 5, where each items mean, 1. "Completely Disagree"; 2. Disagree; 3. "I neither agree nor disagree"; 4. "Agree" and 5; "Completely Agree". To calculate the final score of the questionnaire, the score of each item on the Likert scale is transformed into a score ranging from -2 to 2. The total score of the questionnaire ranges from -50 to 50 points, with values closest to 50 points indicate more adequate beliefs regarding low back pain.

    Post-intervention (i.e. 6 weeks after randomization)

Secondary Outcomes (2)

  • Back Pain Attitudes Questionnaire (Back-PAQ)

    Post-intervention (i.e. 6 weeks after randomization)

  • Beliefs regarding imaging exams

    Post-intervention (i.e. 6 weeks after randomization)

Study Arms (2)

Online educational program

EXPERIMENTAL

A 6-week educational program delivered online based on information and recommendations from international clinical practice guidelines for the management of back pain.

Other: Online educational program

Control group

NO INTERVENTION

The control group will receive no intervention and will be instructed to follow their clinical practice normally.

Interventions

Online educational programOTHER

The intervention group will receive an online educational program, containing current information on low back pain management according to international clinical practice guidelines. Program content includes recommendations on assessment, diagnosis, and treatment of low back pain. The online program has 6 units of studies, with the content offered in the formats of video classes, infographics, texts, websites and clinical cases. The participant must complete the course within 6 weeks and will be able to set their own pace. Participants in the intervention group will receive their login and access password via email.

Online educational program

Eligibility Criteria

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

You may qualify if:

  • must be a licensed physical therapist;
  • currently managing patients with low back pain, regardless of the duration of symptoms, in clinical practice;
  • if not currently managing patients with low back pain, participants must have treated at least one patient in the last month.
  • (Patients with low back pain are defined as those patients reporting pain between the lower border of the last vertebral ribs and the gluteal fold, with or without pain referred to the lower limb).

You may not qualify if:

  • not having access or reporting difficulty in accessing the internet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

Related Publications (3)

  • Diniz LM, Oliveira CB, Machado GC, Maher CG, Verhagen AP, Fernandes DAM, Franco MR, Souza TR, Pinto RZ. Effectiveness of brief patient information materials for promoting correct beliefs about imaging and inevitable consequences of low back pain: A randomised controlled trial. Clin Rehabil. 2022 Apr;36(4):527-537. doi: 10.1177/02692155211065974. Epub 2021 Dec 21.

    PMID: 34931854BACKGROUND

  • Fernandes DAM, Freire APCF, Santos JM, Lemes IR, Diniz LM, FRANCO, MR, Ocarino JM, Pinto RZ. The Modified Back Beliefs Questionnaire as a tool to screen for incorrect beliefs regarding back pain: Cross-cultural adaptation and measurement properties. International Journal of Osteopathic Medicine. 2022; 44: 9-15. https://doi.org/10.1016/j.ijosm.2022.04.001

    BACKGROUND

  • Magalhaes DS, McAuley JH, Maher CG, Ferreira EMR, Oliveira TEP, Mastahinich MER, de Jesus-Moraleida FR, Fukusawa L, Franco MR, Pinto RZ. An e-learning program improves low back pain beliefs of physiotherapists: a randomised trial. J Physiother. 2025 Jan;71(1):35-41. doi: 10.1016/j.jphys.2024.11.014. Epub 2024 Dec 14.

    PMID: 39675949DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rafael Z Pinto, PhD

    Universidade Federal de Minas Geral

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 14, 2022

First Posted

December 22, 2022

Study Start

February 1, 2023

Primary Completion

July 28, 2023

Study Completion

July 28, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)