Low Back PainNCT05661968
Efficacy of an Online Educational Program to Change Back Pain Beliefs in Physical Therapists
A study testing Online educational program in people with Low Back Pain, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Online educational program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2023to 28 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- not having access or reporting difficulty in accessing the internet.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 31270-901
About this study
Official title: 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.
- Conditions
- Low Back Pain
- Being tested
- Online educational program
- Keywords
- Low back pain, Online educational program, Beliefs, Physical Therapists
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-intervention (i.e. 6 weeks after randomization)
Secondary outcomes (2)
Back Pain Attitudes Questionnaire (Back-PAQ)
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.
Measured: Post-intervention (i.e. 6 weeks after randomization)
Beliefs regarding imaging exams
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.
Measured: Post-intervention (i.e. 6 weeks after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Feb 2023
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Zambelli Pinto, Federal University of Minas Gerais
- Investigators
- Rafael Z Pinto, PhD, Principal investigator, Universidade Federal de Minas Geral
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661968
- Sponsor's protocol ID
- CAAE 60756422.6.0000.5149
- Status last verified
- Jul 2023
- First submitted
- 14 Dec 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34931854Fernandes 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
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.
PubMed 39675949
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Online Educational Program to Change Back Pain Beliefs in Physical Therapists: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05661968
- Acronym / sponsor ID
- CAAE 60756422.6.0000.5149
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Online educational program, Beliefs, Physical Therapists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online educational program | Experimental | Other: Online educational programA 6-week educational program delivered online based on information and recommendations from international clinical practice guidelines for the management of back pain. |
| Control group | No intervention | –The control group will receive no intervention and will be instructed to follow their clinical practice normally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- not having access or reporting difficulty in accessing the internet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online educational programThe 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. | Other | Online educational program |
Primary outcome
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.
2 secondary outcomes
Back Pain Attitudes Questionnaire (Back-PAQ)
Time frame: Post-intervention (i.e. 6 weeks after randomization)
Beliefs regarding imaging exams
Time frame: Post-intervention (i.e. 6 weeks after randomization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 34931854Diniz 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.
- BackgroundFernandes 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
- Derived from this study: PubMed 39675949Magalhaes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Z Pinto, PhD principal investigator
Universidade Federal de Minas Geral
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online educational program in people with Low Back Pain, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Back Belief Questionnaire (time frame: Post-intervention (i.e. 6 weeks after randomization)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05661968, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.