Feasibility and Effect of a Multidisciplinary Telematics Approach for Chronic Non-specific Low Back Pain: a Randomized, Open-label, Controlled, Pilot Clinical Trial. Study Protocol
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain is a challenging condition, with a lifetime prevalence of up to 84%. The
      estimated prevalence of chronic non-specific low back pain is of approximately 23%. Although
      pain is a sensory experience triggered by a peripheral stimulus, psychosocial factors
      influence on its perception and on the risk of chronification.

      Chronic Low Back Pain imposes a substantial socioeconomic burden to patients, families, and
      healthcare systems worldwide. It is a multifactorial condition, characterized by a
      combination of physical, psychosocial and occupational factors. We have planned two working
      hypotheses: (1) coordinating several healthcare professionals is feasible to manage chronic
      non-specific low back pain through telematics multidisciplinary approach; (2) telematics
      multidisciplinary approach improves the quality of life of patients with chronic non-specific
      low back pain and in whom conservative treatment has failed. Hence, we aim to assess the
      feasibility and effect of telematics multidisciplinary approach in patients suffering from
      chronic non-specific low back pain and who have not improved with conservative treatment.

      Patients will be randomized to the telematics multidisciplinary approach (Experimental Group)
      or to the Standard of Care (Control Group). Scheduled and periodic telematics
      multidisciplinary sessions will be performed. Each session will consist of an integrated
      program that combines rehabilitation (i.e., group-based exercise program), psychological
      treatment and social work sessions. Standard of Care, after conservative treatment failure,
      depends mainly on the physician in charge's discretion and on the patients' preferences. An
      exploratory analysis will be performed.

      The results of this clinical trial will provide evidence that a scheduled telematics
      multidisciplinary approach will improve the quality of life of these patients and empower
      them to be more autonomous. Likewise, telematics multidisciplinary approach is feasible to
      manage chronic non-specific low back pain in patients unresponsive to conservative treatment.
      Consequently, these patients are less likely to wander through different medical specialties
      seeking for a solution to their condition, presumably avoiding ineffective back surgeries.
      The results will also highlight the importance of patients playing an active role in their
      own treatment to successfully manage chronic non-specific low back pain.
    

Detailed description: 
      Objectives {#7}:

      Hypothesis:

      Two working hypothesis have been planned: i) the coordination of several health care
      professionals is feasible to manage CnsLBP (Chronic non-specific Low Back Pain) through
      telematics multidisciplinary approach; ii) telematics multidisciplinary approach improves the
      quality of life of patients who suffer from CnsLBP and in whom conservative treatment has
      failed

      Primary Objective The primary aims are to assess the feasibility and effect of the telematics
      multidisciplinary approach in patients who suffer from non-specific CnsLBP and in whom
      conservative treatment has failed.

      Secondary objectives

      The secondary objectives are:

        1. to quantify the desertion rate

        2. to study the level of usual physical activity

        3. to quantify disability due to CnsLBP

        4. to study anxiety and depression

        5. to assess chronic pain coping strategies

        6. to study self-awareness and emotional self-regulation

        7. to evaluate perceived social support

        8. to estimate mental well-being

      Trial Design {#8}:

      This is an open-label, randomized, controlled, parallel-group, pilot clinical trial. Patients
      will be randomized to the telematic multidisciplinary biopsychosocial approach (Experimental
      Group) or to the Standard of Care (Control Group).

      This pilot clinical trial will provide evidence on the feasibility of the coordination of
      several health care professionals to manage CnsLBP through telematics multidisciplinary
      approach; and it will provide the first evidence on the impact of the telematics
      multidisciplinary approach on the QoL of these patients.

      The target population will be patients with CnsLBP who have already undergone rehabilitation
      and pain clinic therapy and are still in pain and seeking for a solution (i.e., patients on a
      waiting list to see a spine surgeon for surgical assessment, patients who might be candidates
      to lumbar surgery depending on their evolution, patients being followed up by a Pain Clinic
      specialist or by their assigned General Practitioner specialist). If during the trial it is
      decided to perform a lumbar surgical intervention on an included patient, he/she will be
      automatically excluded from the trial.

      Methods: Participants, Interventions and Outcomes

      Study Setting {#9}:

      This trial will be carried out in the premises of the Bellvitge University Hospital (a
      tertiary hospital), the Viladecans Hospital (a secondary hospital) and primary care centers:
      Delta del Llobregat Primary Care Center, L'Hospitalet de Llobregat Mental Health Unit, Santa
      Eulalia Primary Care Center.
    

Intervention name(s): physical rehabilitation/physiotherapy and psychosocial group sessions
Intervention type(s): Behavioral
Intervention description(s): physical rehabilitation/physiotherapy and psychosocial group sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment