- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05661968
Efficacy of an Online Educational Program to Change Back Pain Beliefs in Physical Therapists
Efficacy of an Online Educational Program to Change Back Pain Beliefs in Physical Therapists: a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rafael Z Pinto, PhD
- Phone Number: +55 31 984498278
- Email: rafaelzp@ufmg.br
Study Contact Backup
- Name: Daniela S Magalhães, PT
- Phone Number: +55 31 981028703
- Email: dani_m152@hotmail.com
Study Locations
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 31270-901
- Universidade Federal de Minas Gerais
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- not having access or reporting difficulty in accessing the internet.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Online educational program
A 6-week educational program delivered online based on information and recommendations from international clinical practice guidelines for the management of back pain.
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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.
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No Intervention: Control group
The control group will receive no intervention and will be instructed to follow their clinical practice normally.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Back Belief Questionnaire
Time Frame: Post-intervention (i.e. 6 weeks after randomization)
|
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.
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Post-intervention (i.e. 6 weeks after randomization)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Back Pain Attitudes Questionnaire (Back-PAQ)
Time Frame: Post-intervention (i.e. 6 weeks after randomization)
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The items in this questionnaire comprise general aspects related to low back pain, including beliefs about pain-related behavior and symptom recovery.
The short version of the questionnaire with 10 items will be used.
Each item is scored on a 5-point Likert scale.
The total score of the questionnaire ranges from -20 to 20, with lower values (or closer to 20) indicating more adequate beliefs.
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Post-intervention (i.e. 6 weeks after randomization)
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Beliefs regarding imaging exams
Time Frame: Post-intervention (i.e. 6 weeks after randomization)
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Beliefs regarding imaging exams will be measured using two statements from a previous study5: Q1- 'X-rays or scans are necessary to get the best medical care for low back pain'; Q2 - 'Everyone with low back pain should have spine imaging (e.g.
X-ray, computed tomography or magnetic resonance imaging)'.
Participants indicated their agreement with each statement on a 5-point Likert scale of 'Strongly Disagree' (1) to 'Strongly Agree' (5).
The 5-point Likert responses will be dichotomised into two categories: correct beliefs (disagree or strongly disagree) and incorrect beliefs (neither agree nor disagree, agree or strongly agree) about imaging prescription.
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Post-intervention (i.e. 6 weeks after randomization)
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Collaborators and Investigators
Investigators
- Principal Investigator: Rafael Z Pinto, PhD, Universidade Federal de Minas Geral
Publications and helpful links
General Publications
- 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.
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE 60756422.6.0000.5149
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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