Chronic Nonspecific Low Back PainNCT02962817
The Influence of an Educational Intervention in the Beliefs and Attitudes of Primary Care Professionals
A study testing Educational intervention and Video explaining the clinical practice guidelines on low back pain in people with Chronic Nonspecific Low Back Pain, run by Universitat de Lleida at 1 site in Spain.
Trial summary
Aim: The primary aim of this project is to identify the fear-avoidance beliefs and attitudes of primary care physicians and nurses towards the treatment of chronic nonspecific low back pain to subsequently develop a biopsychosocial educational tool using a web platform. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Chronic Nonspecific Low Back Pain
- What is being tested?
- Educational intervention and Video explaining the clinical practice guidelines on low back pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2016to Jun 2022
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Graduated in medicine and specialized in family and community medicine.
- Graduates in nursing.
- Registered health professionals.
- Professionals working in any of the primary care centers.
- Accept and sign the informed consent form.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of an Educational Internet-based Intervention in the Beliefs and Attitudes of Primary Care Professionals on Non-specific Chronic Low Back Pain: Study Protocol of a Mixed Methods Approach
Aim: The primary aim of this project is to identify the fear-avoidance beliefs and attitudes of primary care physicians and nurses towards the treatment of chronic nonspecific low back pain to subsequently develop a biopsychosocial educational tool using a web platform. The secondary aim of this project is to evaluate the effectiveness of this educational intervention about pain neurophysiology and fear-avoidance beliefs, using a web platform for primary care physicians and nurses.
Methods: Exploratory sequential mixed method design. For the qualitative phase of this study, researchers will use personal semistructured interviews. For the quantitative phase the authors will use an experimental study design.
Read more
Subjects: medical and nursing staff working in primary care centers in the city of Lleida, Spain.
Expected outcomes: the authors expect to change and modify wrong beliefs and attitudes about chronic low back pain of physicians and nurses working in primary care settings, using a web-based educational tool with the additional result of increasing knowledge on pain neurophysiology and reducing fear-avoidance beliefs.
Read the detailed description
HYPOTHESIS AND OUTCOMES
Hypothesis:
- The beliefs and attitudes of fear-avoidance of primary care professionals are held by lack of knowledge about the origin and meaning of pain.
- The neurophysiology of pain as a biopsychosocial educational intervention using a web platform for primary care professionals will change their knowledge about the origin and meaning of pain, with the result of reducing the beliefs and attitudes of fear avoidance.
Outcomes:
- Qualitative:
- To identify the fear-avoidance beliefs and attitudes of primary care professionals towards the treatment of chronic nonspecific low back pain in relation to the origin and meaning of pain.
- To build and develop using a web platform a biopsychosocial educational intervention based on the results obtained in the qualitative phase.
- Quantitative:
- To evaluate the effectiveness of a biopsychosocial educational intervention about pain neurophysiology and fear-avoidance beliefs related to non-specific chronic low back pain, using a web platform for primary care professionals.
METHODOLOGY DESING To answer the research question a mixted-method sequential exploratory design will be used. This mixed-method design consists of two stages, where the results of the methodology used in the first phase of the study, in this case qualitative, contribute to the development of the second quantitative phase. In this project, both phases should have the same relevance for the development of an educational tool for primary care professionals. Using a mixed design methodology is justified in this protocol because the integration of both (qualitative and quantitative) methodologies occurs when data from the qualitative phase contributes to the construction of an educational tool.
The process to be followed is:
- Qualitative: Semistructured personal interviews.
- Quantitative: An experimental study design in which a sample of specialized physicians in family and community care and nurses working in primary care health centers will be randomly assigned to the experimental group and the control group.
SUBJECTS:
- Qualitative and quantitative: To start the recruitment process, the principal investigator will do a presentation of the project in each of the primary care centers in the city of Lleida addressed to the medical and nursing staff. Professionals will be invited to participate in the study, either in the qualitative or quantitative phase, and will be provided a phone number and an email address through which they can contact the researcher and agree on the interview date. In the quantitative phase, health professionals who meet the inclusion criteria will be informed about the intervention and the author will answer any questions or concerns that may arise. At the end of this first contact the professionals will be asked to read and sign the informed consent.
- Qualitative: Subjects who agree to be part of the qualitative study will be contacted by the author and invited to participate in a deep semistructured interview. Individual interviews will be conducted in Spanish or Catalan and will be audio recorded with the consent of interviewed professionals. To increase participation, interviews will be conducted in designated areas in the primary health centers, during working hours. The duration of the interview will be approximately 1 hour.
- Quantitative: Subjects will be randomly allocated to either intervention or control group using a simple randomization method.
Intervention group: This group will have access to the web platform where they will find information related to nonspecific chronic low back pain. This information will be presented using dynamic explanatory videos made by the author.
Control group: They will have access to a video where medical staff and primary care nurses explain the content of the clinical practice guidelines for addressing back pain.
- Conditions
- Chronic Nonspecific Low Back Pain
- Being tested
- Educational intervention, Video explaining the clinical practice guidelines on low back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionOther
Video explaining the clinical practice guidelines on low back painOther
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention through a web platform | Experimental | This group will have access to our web platform where they will find information related to nonspecific chronic low back pain. This information will be presented through dynamic explanatory 3D videos made by the author.
The aim of this intervention is to change and modify wrong beliefs and attitudes about chronic low back pain of physicians and nurses working in primary care settings, using a web-based educational tool with the additional result of increasing knowledge on pain neurophysiology and reducing fear-avoidance beliefs. Receives: Other: Educational intervention |
| Clinical practice guidelines on low back pain | Active comparator | Control group: They will have access to a video where medical staff and primary care nurses explain the content of the clinical practice guideline for addressing back pain. Receives: Other: Video explaining the clinical practice guidelines on low back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge about the pain neurophysiology
Using the pain neurophysiology questionnaire. This self-administered questionnaire was developed by Lorimer Moseley in 2003 to assess how an individual conceptualizes pain. An acceptable internal consistency and good test-retest reliability was demonstrated. The original English version was translated into Spanish by the Language Service of the Rovira and Virgili University. The questionnaire consists of 19 statements that refer to the origin and meaning of pain with three possible answers: true, false or doubtful. Each correct answer is scored with 1 point, while incorrect, doubtful or unanswered responses are scored with 0 points.
Measured: 2 weeks
Secondary outcomes (2)
Fear-avoidance beliefs
Using the Health Care Providers Pain and Impairment Relationship Scale. This self-administered questionnaire was designed to assess attitudes and beliefs of primary care physicians on chronic nonspecific low back pain. Domenech et al. translated into Spanish the original English version in 2013. After the cross-cultural adaptation, the Spanish version of HC-PAIRS proved to be a reliable, valid and sensitive instrument. The questionnaire consists of 15 statements that suggest a direct link between pain and functional limitation and disability. Each statement is followed by a 7 point Likert scale (1 = strongly disagree, 4 = neither agree nor disagree and 7 = strongly agree). The total score ranges from 1 to 105. Higher scores indicate strong beliefs.
Measured: 2 weeks
Fear-avoidance beliefs and attitudes
Using the Fear Avoidance Beliefs Questionnaire. This self-administered questionnaire was developed to measure the beliefs and attitudes of fear-avoidance in patients with low back pain towards physical and / or occupational activities. The questionnaire is divided into two subscales: FABQ-physical activity and FABQ-work. It consists of a total of 16 statements about the beliefs of patients with low back pain about the relationship between pain and physical and labor activity. Each statement is followed by a 6 point Likert scale (0 = strongly disagree and 6 = strongly agree). For both subscales high scores indicate strong fear-avoidance beliefs. This questionnaire has been validated in Spanish. The Spanish version of the FABQ has good internal consistency and reliability. Although it was created to assess fear-avoidance beliefs of patients, this questionnaire has also been used to measure the beliefs of general practitioners and rheumatologists.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2018
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Nonspecific 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester García Martínez, Universitat de Lleida
- Investigators
- Francesc Valenzuela Pascual, BSc(PT), Study director, Universitat de LleidaJorge Soler Gonzalez, MD, Study director, Universitat de LleidaEster García Martínez, BSc(PT), Principal investigator, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962817
- Sponsor's protocol ID
- ULleida P16/124
- Status last verified
- Dec 2021
- First submitted
- 9 Nov 2016
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Garcia-Martinez E, Soler-Gonzalez J, Blanco-Blanco J, Rubi-Carnacea F, Masbernat-Almenara M, Valenzuela-Pascual F. Misbeliefs about non-specific low back pain and attitudes towards treatment by primary care providers in Spain: a qualitative study. BMC Prim Care. 2022 Jan 14;23(1):9. doi: 10.1186/s12875-021-01617-3.
PubMed 35172719Garcia-Martinez E, Soler-Gonzalez J, Rubi-Carnacea F, Garcia-Martinez B, Climent-Sanz C, Blanco-Blanco J, Valenzuela-Pascual F. The influence of an educational internet-based intervention in the beliefs and attitudes of primary care professionals on non-specific chronic low back pain: study protocol of a mixed methods approach. BMC Fam Pract. 2019 Feb 21;20(1):31. doi: 10.1186/s12875-019-0919-6.
PubMed 30791879
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of an Educational Internet-based Intervention in the Beliefs and Attitudes of Primary Care Professionals on Non-specific Chronic Low Back Pain: Study Protocol of a Mixed Methods Approach
- ClinicalTrials.gov ID
- NCT02962817
- Acronym / sponsor ID
- ULleida P16/124
- Conditions
- Chronic Nonspecific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 11 Nov 2016 (estimated)
- 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.
Aim: The primary aim of this project is to identify the fear-avoidance beliefs and attitudes of primary care physicians and nurses towards the treatment of chronic nonspecific low back pain to subsequently develop a biopsychosocial educational tool using a web platform. The secondary aim of this project is to evaluate the effectiveness of this educational intervention about pain neurophysiology and fear-avoidance beliefs, using a web platform for primary care physicians and nurses.
Methods: Exploratory sequential mixed method design. For the qualitative phase of this study, researchers will use personal semistructured interviews. For the quantitative phase the authors will use an experimental study design.
Subjects: medical and nursing staff working in primary care centers in the city of Lleida, Spain.
Expected outcomes: the authors expect to change and modify wrong beliefs and attitudes about chronic low back pain of physicians and nurses working in primary care settings, using a web-based educational tool with the additional result of increasing knowledge on pain neurophysiology and reducing fear-avoidance beliefs.
Detailed description
HYPOTHESIS AND OUTCOMES
Hypothesis:
- The beliefs and attitudes of fear-avoidance of primary care professionals are held by lack of knowledge about the origin and meaning of pain.
- The neurophysiology of pain as a biopsychosocial educational intervention using a web platform for primary care professionals will change their knowledge about the origin and meaning of pain, with the result of reducing the beliefs and attitudes of fear avoidance.
Outcomes:
- Qualitative:
- To identify the fear-avoidance beliefs and attitudes of primary care professionals towards the treatment of chronic nonspecific low back pain in relation to the origin and meaning of pain.
- To build and develop using a web platform a biopsychosocial educational intervention based on the results obtained in the qualitative phase.
- Quantitative:
- To evaluate the effectiveness of a biopsychosocial educational intervention about pain neurophysiology and fear-avoidance beliefs related to non-specific chronic low back pain, using a web platform for primary care professionals.
METHODOLOGY DESING To answer the research question a mixted-method sequential exploratory design will be used. This mixed-method design consists of two stages, where the results of the methodology used in the first phase of the study, in this case qualitative, contribute to the development of the second quantitative phase. In this project, both phases should have the same relevance for the development of an educational tool for primary care professionals. Using a mixed design methodology is justified in this protocol because the integration of both (qualitative and quantitative) methodologies occurs when data from the qualitative phase contributes to the construction of an educational tool.
The process to be followed is:
- Qualitative: Semistructured personal interviews.
- Quantitative: An experimental study design in which a sample of specialized physicians in family and community care and nurses working in primary care health centers will be randomly assigned to the experimental group and the control group.
SUBJECTS:
- Qualitative and quantitative: To start the recruitment process, the principal investigator will do a presentation of the project in each of the primary care centers in the city of Lleida addressed to the medical and nursing staff. Professionals will be invited to participate in the study, either in the qualitative or quantitative phase, and will be provided a phone number and an email address through which they can contact the researcher and agree on the interview date. In the quantitative phase, health professionals who meet the inclusion criteria will be informed about the intervention and the author will answer any questions or concerns that may arise. At the end of this first contact the professionals will be asked to read and sign the informed consent.
- Qualitative: Subjects who agree to be part of the qualitative study will be contacted by the author and invited to participate in a deep semistructured interview. Individual interviews will be conducted in Spanish or Catalan and will be audio recorded with the consent of interviewed professionals. To increase participation, interviews will be conducted in designated areas in the primary health centers, during working hours. The duration of the interview will be approximately 1 hour.
- Quantitative: Subjects will be randomly allocated to either intervention or control group using a simple randomization method.
Intervention group: This group will have access to the web platform where they will find information related to nonspecific chronic low back pain. This information will be presented using dynamic explanatory videos made by the author.
Control group: They will have access to a video where medical staff and primary care nurses explain the content of the clinical practice guidelines for addressing back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational intervention through a web platform | Experimental | Other: Educational interventionThis group will have access to our web platform where they will find information related to nonspecific chronic low back pain. This information will be presented through dynamic explanatory 3D videos made by the author. The aim of this intervention is to change and modify wrong beliefs and attitudes about chronic low back pain of physicians and nurses working in primary care settings, using a web-based educational tool with the additional result of increasing knowledge on pain neurophysiology and reducing fear-avoidance beliefs. |
| Clinical practice guidelines on low back pain | Active comparator | Other: Video explaining the clinical practice guidelines on low back painControl group: They will have access to a video where medical staff and primary care nurses explain the content of the clinical practice guideline for addressing back pain. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Graduated in medicine and specialized in family and community medicine.
- Graduates in nursing.
- Registered health professionals.
- Professionals working in any of the primary care centers.
- Accept and sign the informed consent form.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Educational intervention | Other | Educational intervention through a web platform |
| Video explaining the clinical practice guidelines on low back pain | Other | Clinical practice guidelines on low back pain |
Primary outcome
Knowledge about the pain neurophysiology
Time frame: 2 weeks
Using the pain neurophysiology questionnaire. This self-administered questionnaire was developed by Lorimer Moseley in 2003 to assess how an individual conceptualizes pain. An acceptable internal consistency and good test-retest reliability was demonstrated. The original English version was translated into Spanish by the Language Service of the Rovira and Virgili University. The questionnaire consists of 19 statements that refer to the origin and meaning of pain with three possible answers: true, false or doubtful. Each correct answer is scored with 1 point, while incorrect, doubtful or unanswered responses are scored with 0 points.
2 secondary outcomes
Fear-avoidance beliefs
Time frame: 2 weeks
Fear-avoidance beliefs and attitudes
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Derived from this study: PubMed 35172719Garcia-Martinez E, Soler-Gonzalez J, Blanco-Blanco J, Rubi-Carnacea F, Masbernat-Almenara M, Valenzuela-Pascual F. Misbeliefs about non-specific low back pain and attitudes towards treatment by primary care providers in Spain: a qualitative study. BMC Prim Care. 2022 Jan 14;23(1):9. doi: 10.1186/s12875-021-01617-3.
- Derived from this study: PubMed 30791879Garcia-Martinez E, Soler-Gonzalez J, Rubi-Carnacea F, Garcia-Martinez B, Climent-Sanz C, Blanco-Blanco J, Valenzuela-Pascual F. The influence of an educational internet-based intervention in the beliefs and attitudes of primary care professionals on non-specific chronic low back pain: study protocol of a mixed methods approach. BMC Fam Pract. 2019 Feb 21;20(1):31. doi: 10.1186/s12875-019-0919-6.
- 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.
Francesc Valenzuela Pascual, BSc(PT) study director
Universitat de Lleida
Jorge Soler Gonzalez, MD study director
Universitat de Lleida
Ester García Martínez, BSc(PT) principal investigator
Universitat de Lleida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention and Video explaining the clinical practice guidelines on low back pain in people with Chronic Nonspecific Low Back Pain, run by Universitat de Lleida at 1 site in Spain.
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 5 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 10 Dec 2021. 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 Spain. 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?
Results are not available in the source record.
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?
Knowledge about the pain neurophysiology (time frame: 2 weeks). 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 NCT02962817, which also lists 2 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 10 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.