Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT02962817 |
| Other study ID # |
ULleida P16/124 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2016 |
| Est. completion date |
June 2022 |
Study information
| Verified date |
December 2021 |
| Source |
Universitat de Lleida |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
Description:
HYPOTHESIS AND OUTCOMES
Hypothesis:
1. The beliefs and attitudes of fear-avoidance of primary care professionals are held by
lack of knowledge about the origin and meaning of pain.
2. 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:
1. 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.
2. To build and develop using a web platform a biopsychosocial educational
intervention based on the results obtained in the qualitative phase.
- Quantitative:
1. 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.
