Influence of a Educational Internet-based Intervention in Chronic Low Back Pain Patients: A Mixed Methods Approach
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Aim: The aim of this project is to identify chronic low back pain patients´ beliefs about the
      origin and meaning of pain for developing a biopsychosocial web-based educational
      intervention. The other aim of this project is to assess the effectiveness of this web-based
      educational intervention for chronic low back pain patients on pain cognitions, pain
      intensity, and disability.

      Methods: Mixed methods design, combining both qualitative and quantitative methodologies. For
      the qualitative part of this study, the investigators will use qualitative in-depth
      semi-structured interviews. For the quantitative phase we will use an experimental study
      design.

      Subjects: Chronic low back pain patients between 18-65 years old, attending a primary care
      setting in the city of Lleida.

      Expected outcomes: The investigators expect to change and modify chronic low back pain
      patients´ cognition by using our web-site educational intervention, with the further outcome
      of reducing pain and disability.
    

Detailed description: 
      Hypothesis and outcomes

      Hypothesis:

        1. Persistent chronic low back pain and its consequences are maintained by the lack of
           understanding about the origin and meaning of pain.

        2. Pain neurophysiology as an educational internet- based intervention for chronic low back
           pain will change cognition about the origin and meaning of pain, with the outcome of
           pain reduction, disability reduction, and better quality of life compared to normal
           care.

      Outcomes:

      There are specific objectives for each phase of the study.

      Phase 1 (QUAL):

      To identify chronic low back pain patients' beliefs concerning the origin and meaning of
      pain.

      Phase 2 (Connecting procedure):

      To construct and develop a biopsychosocial web- based educational intervention using the QUAL
      results.

      Phase 2 (QUAN):

      Primary outcome. To evaluate the effect of a biopsychosocial web-based educational
      intervention for chronic low back pain based on pain intensity compared to normal care.

      Secondary outcomes. To assess the effect of a biopsychosocial web-based educational
      intervention for chronic low back pain compared to normal care on:

        -  Fear avoidance beliefs.

        -  Kinesiophobia.

        -  Disability.

      Methodology Study design

      To answer the research question, the authors will use a mixed-method sequential exploratory
      design. The pur- pose of mixed methodology is not to replace qualitative or quantitative
      methodologies, but to use the strengths of both while reducing their weaknesses. Specific-
      ally, the sequential exploratory design includes an initial qualitative phase followed by a
      quantitative phase, with the aim of developing an educational tool. In this project, we
      propose that both phases (qualitative and quantitative) must have the same relevance (QUAL-
      QUAN) for the development of the educational tool and that the development of the study must
      be conducted in three stages:

        1. Qualitative data collection through semi-structured personal interviews followed by
           thematic analysis.

        2. Construction of the educational tool with the results obtained in the previous step
           (topics or emerging categories).

        3. Analysis of the effectiveness of the educational tool using a randomized controlled
           trial.

      Scope: Primary care

      SUBJECTS:

      The recruitment process will be performed independently in each phase of the study, although
      in both phases this recruitment process will take place in the same pri- mary care centers in
      the city of Lleida through family physicians. The inclusion and exclusion criteria are also
      common to both phases. Prior to the beginning of the first phase, the first author of this
      study will perform a presentation of the project to the medical and nursing staff in each of
      the primary care centers involved in the study to ask for their cooperation.

      QUAL: In this phase, patients will be recruited by their respective family physicians. Once
      the physician makes the diagnosis of CLBP and ensures that the individual meets the inclusion
      and exclusion criteria, the physician informs the patient about the existence of this project
      and invites him to contact the first author by telephone. If the person agrees to participate
      in the study, the inter- view will be scheduled to take place in the Faculty of Nursing and
      Physiotherapy of the University of Lleida.

      QUAN: The recruitment process will start after the end of QUAL and the development of the
      educational tool. This phase will consist of an educational interven- tion using a randomized
      controlled trial design. The re- cruitment process will be the same as in QUAL. Prior to the
      beginning of the intervention, the first author will meet the study subjects individually to
      inform them of the study conditions and provide them with the informed consent form.
    

Intervention name(s): Educational intervention; Normal care by GP
Intervention type(s): Other; Other
Intervention description(s): The internet platform will provide patients with customized tasks that allow them to use the metaphor of the journey (the narrative as a dynamic of the game) to feel that they manage their own path, which will change negative perceptions into positive perceptions about certain actions. At all times, the patients will be able to choose among different information sources, such as videos about the origin of chronic pain, 3D representations of different neurophysiological processes, and FAQs. Additionally, the patients will be able to contact a specialist in the neurophysiology of pain by email or videoconference. Furthermore, to reinforce patients' motivation and participation, gamification techniques will be implemented.; Patients will follow GP advice including NSAID medication if needed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: patient education; pain cognitions