Digital Care Program for Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      New ways of delivering care are much needed to address chronic low back pain. Crucially,
      these need to: a) address the three pillars of care to achieve good and sustained clinical
      outcomes; b) overcome barriers to access; c) ensure patients are engaged throughout the
      programs; d) be scalable and cost-efficient. SWORD Health has developed a digital care
      program to address these needs. This study aims to assess the clinical outcomes of this
      rehabilitation program versus conventional physical therapy.
    

Detailed description: 
      Low back pain (LBP) has for long been the world's leading cause of years leaved with
      disability,1 and, considering that the overall life expectancy is rising, this pandemic only
      tends to get worse. Nearly everyone is affected by LBP at some moment in life (70-80% of
      lifetime prevalence). As a consequence, LBP is also presented as a leading cause of work
      absenteeism worldwide. Thus, although the estimate costs of LBP may be difficult to compare
      between different countries, its overwhelming socio-economic impact in modern society is
      evident.

      In the absence of an effective treatment, LBP can become chronic, causing a huge impact in
      patients' daily life, and ultimately promoting a high consumption of healthcare resources. In
      the US alone, health expenditures for adults with spinal problems were estimated at $6000 per
      person, representing a total cost of $102 billion each year.

      The dim picture described above highlights the urgent need for effective interventions that
      minimize disability, improve quality of life and decrease productivity losses.

      Current guidelines on CLBP management recommend patient education, exercise, physical therapy
      (PT), and behavioural therapy as the mainstay treatments for this condition.

      Despite some discrepancy in the type of exercise program (e.g. aquatic exercises, stretching,
      back schools, McKenzie exercise approach, yoga, tai-chi) and mode of delivery (e.g.,
      individually designed programs, supervised home exercise, and group exercise), exercise
      therapy is recommended nearly transversally, with most studies concluding that exercise
      intervention programs should include a combination of muscular strength, flexibility and
      aerobic fitness exercises. Moreover, home exercises with a regular therapist follow-up has
      proven highly effective.

      This is not, however, how LBP is currently managed. Appropriate patient education and
      structured behavioural training are rarely provided, and opioid prescription is also a common
      practice, despite known opioid-related morbidity and mortality rates. Because the prevalence
      of CLBP is continuously rising, and opioid misuse is an issue of great concern globally,
      identifying effective nonopioid alternatives for CLBP is of paramount importance.

      Further compounding this problem, from the patients who are directed to PT, almost half give
      up after just 4 sessions, and only 30% complete their programs.

      In this context, new ways of delivering care are much needed. Crucially, these need to: a)
      address the three pillars of care to achieve good and sustained clinical outcomes; b)
      overcome barriers to access; c) ensure patients are engaged throughout the programs; d) be
      scalable and cost-efficient.

      This study aims to assess the clinical outcomes of a digital program for chronic low back
      pain versus conventional PT.
    

Intervention name(s): Digital program; Conventional PT
Intervention type(s): Device; Other
Intervention description(s): Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health. These patients will be referred to SWORD Health by the investigator who identified the candidate. SWORD Health will then assign a physical therapist to each patient. The physical therapist will contact the patient for onboarding and will manage the case.; Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face PT sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program will follow the protocol outlined in Annex 3, which can however be adapted by the physical therapist to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled PT sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment