LOw Level of Activity (LOLA): Education and Exercise-based Intervention for Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Chronic pain of moderate to severe intensity occurs in 19% of adult Europeans. Non-specific
      low-back pain is one of the most prevalent symptoms and the main cause of disability in
      industrialized countries, generating significant public health expenditure on health and
      occupational care. The combination of pain neurophysiology education and therapeutic exercise
      has shown positive effects in patients with chronic non-specific low back pain. Mobile health
      tools (mHealth) are proposed as a cost-effective alternative to continuously record the daily
      activities of patients and to provide rapid feedback to users and clinicians, reducing visits
      to clinics. A 4-week (8-session) education and exercise-based intervention will be carried
      out in a group of patients with non-specific chronic low back pain using two modalities: (1)
      face-to-face guided by a health professional or (2) self-managed through BackFit App. The
      sample will be divided into two groups and will be evaluated before (pre), after (post) and 3
      months (follow-up) after the intervention.
    

Detailed description: 
      The objectives of this study are:

        1. To assess the influence of a 4-week (8 sessions) intervention based on education (about
           pain neurophysiology and healthy lifestyle habits) and physical exercise (strength,
           flexibility, joint mobility, and self-massage) on pressure pain thresholds (PPT) and
           cognitive functioning (selective attention), as primary variable outcomes, and on
           physical condition (balance and range of movement), affective and cognitive symptoms
           (mood, anxiety, catastrophizing, fear-avoidance beliefs and kinesiophobia), pain
           interference and self-reported clinical pain, as secondary variable outcomes, in
           patients with non-specific chronic low back pain.

        2. To evaluate the effectiveness of a mobile health application developed by researchers
           (BackFit App) to carry out the intervention, in comparison with a supervised
           intervention by a health professional.

      The hypotheses of the study are:

        1. This intervention based on education and physical exercise will increase PPT and improve
           selective attention.

        2. This intervention will also improve physical condition, self-reported clinical pain,
           affective and cognitive symptoms and pain interference presented by patients with
           chronic low back pain.

        3. The intervention performed with BackFit App will be as effective as that supervised by a
           health professional.
    

Intervention name(s): face-to-face protocol; self-managed protocol
Intervention type(s): Other; Other
Intervention description(s): The intervention is based on education (on pain neurophysiology and healthy lifestyle habits) and physical exercise (strength, flexibility, joint mobility and self-massage).; Subjects of this group receive the same intervention content as the other experimental group, but through a mobile application.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mobile Applications; Muscle and Stretching Exercises; Physical Exercise; Behavior