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The Influence of an Educational Intervention in the Beliefs and Attitudes of Primary Care Professionals

Primary Purpose

Chronic Nonspecific Low Back Pain

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Educational intervention
Video explaining the clinical practice guidelines on low back pain
Sponsored by
Universitat de Lleida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Nonspecific Low Back Pain

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Graduated in medicine and specialized in family and community medicine.
  2. Graduates in nursing.
  3. Registered health professionals.
  4. Professionals working in any of the primary care centers.
  5. Accept and sign the informed consent form.

Exclusion Criteria: nothing

Sites / Locations

  • Primary care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Educational intervention through a web platform

Clinical practice guidelines on low back pain

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 9, 2016
Last Updated
December 2, 2021
Sponsor
Universitat de Lleida
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1. Study Identification

Unique Protocol Identification Number
NCT02962817
Brief Title
The Influence of an Educational Intervention in the Beliefs and Attitudes of Primary Care Professionals
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat de Lleida

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Nonspecific Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Educational intervention through a web platform
Arm Type
Experimental
Arm Description
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.
Arm Title
Clinical practice guidelines on low back pain
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Educational intervention
Intervention Type
Other
Intervention Name(s)
Video explaining the clinical practice guidelines on low back pain
Primary Outcome Measure Information:
Title
Knowledge about the pain neurophysiology
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Fear-avoidance beliefs
Description
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.
Time Frame
2 weeks
Title
Fear-avoidance beliefs and attitudes
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: nothing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesc Valenzuela Pascual, BSc(PT)
Organizational Affiliation
Universitat de Lleida
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jorge Soler Gonzalez, MD
Organizational Affiliation
Universitat de Lleida
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ester García Martínez, BSc(PT)
Organizational Affiliation
Universitat de Lleida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary care
City
Lleida
ZIP/Postal Code
25198
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35172719
Citation
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.
Results Reference
derived
PubMed Identifier
30791879
Citation
Garcia-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.
Results Reference
derived

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The Influence of an Educational Intervention in the Beliefs and Attitudes of Primary Care Professionals

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