Mechanical Low Back Pain Clinical Trial
Official title:
Optimizing Management of Low Back Pain Through the Pain and Disability Drivers Management Model: Study Protocol for a Feasibility Trial
This study aims to determine the feasibility of conducting a future randomized controlled
trial to collect preliminary data on the effectiveness of a previously validated approach
that takes into account all the pain and disability vectors associated with low back pain -
the Pain and Disability Drivers Management Model (PDDM).
The overall objective is to provide data to assess the feasibility of implementing a future
randomized clinical trial to evaluate the impact of the PDDM on the management of
non-specific LBP in a clinical setting and to explore the short-term effect of using the
model on patient's clinical outcomes.
Background: Non-specific mechanical low back pain (LBP) is highly prevalent, recurrent and is
a leading cause of disability worldwide. Despite increased efforts in improving care, the
self-reported levels of disability in individuals with LBP have not improved in the last
decade. In order to more effectively manage LBP through non-pharmacological approaches,
evidence endorses the use of classification systems to support diagnosis and guide
treatments. However, this approach to care is not without limitations and a more
comprehensive and broader perspective is needed. Hence, we recently proposed and validated
the Low Back Pain and Disability Drivers Management (PDDM) model, which aims to identify the
domains influencing pain and disability to create a profile or phenotype to guide clinical
decisions. The objective of this study is to assess the feasibility of conducting a trial and
to gather preliminary effect outcomes of the intervention in clinical setting.
Methods: The design is a prospective single arm experimental design. Physiotherapists (PTs)
working with a population suffering from musculoskeletal disorders and patients presenting
with non-specific mechanical LBP from two different clinical settings will be recruited. The
intervention consists of a one-day training workshop for PTs on using the PDDM to guide
management decisions. PTs will then perform a 6-weeks follow-up with their participating
patients. This feasibility study will assess recruitment and retention rates as well as PTs'
acceptability and patients' satisfaction outcomes related to the intervention. Preliminary
effect outcomes will also be gathered.
Discussion: This study will inform the feasibility and acceptability of the intervention and
gather preliminary outcomes to conduct a future randomized controlled trial to measure the
effectiveness of the intervention in managing non-specific mechanical LBP.
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