Full-thickness Rotator Cuff Tear Clinical Trial
Official title:
Why Does my Shoulder Hurt? Identifying Factors Associated With the Presence of Pain in Individuals With Full-thickness Rotator Cuff Tears
Full-thickness rotator cuff tears (FTRCT), defined as "through-and-through" tears of one of
the shoulder tendons, affect up to 32% of the population (mostly individuals older than 50
years) and are one of the most painful and debilitating shoulder diagnoses. One of the
primary challenges for clinical decision-making is the poor association between the presence
of FTRCT (detected by medical imaging) and pain, as studies have shown that 2/3 of people
with FTRCT are asymptomatic. This challenges the notion that FTRCT causes pain, and
highlights the fact that symptoms may be explained by other variables. A better understanding
of the factors leading to the development of pain in people with FTRCT would optimize
clinical care (including prevention).
The objective of this study is to identify variables associated with pain in people with
FTRCT by 1) comparing people with FTRCT with (Symptomatic Group; n=40) and without pain
(Asymptomatic Group; n=40); 2) comparing people who initially have pain-free FTRCT
(Asymptomatic Group) who develop pain over a 2-year period to those who do not develop pain;
and 3) comparing people who initially have painful FTRCT (Symptomatic Group) who become
pain-free over a 2-year period to those who remain symptomatic. All participants will undergo
an ultrasound examination to confirm the presence of FTRCT, and information on a number of
variables (sociodemographic, anatomical, genetic, psychosocial, pain sensitivity,
neuromuscular, biomechanical) will be collected. All participants will then be followed for 2
years before being revaluated for pain. Variables will be analysed to determine those
associated with pain. As it is crucial to improve our understanding of the mechanisms leading
to pain, this project has the potential to impact the musculoskeletal health of Canadians. By
considering multiple variables associated with FTRCT, its results could lead to the
development of tangible solutions to optimize prevention and recovery.
Background: Symptomatic full-thickness rotator cuff tears (FTRCT) affect up to 32% of the
population and represent one of the more painful and debilitating shoulder diagnoses. The
prevailing model for care pathway decisions is heavily influenced by medical imaging. Yet,
the association between FTRCT observed on medical imaging and the presence of pain is poor,
as two thirds of FTRCT are asymptomatic. This poses a great challenge to clinical
decision-making and questions the belief that FTRCT causes pain. As other factors may explain
the presence of pain, a better understanding of this phenomenon needs to be sought.
Objective/hypothesis: The primary objective is to identify variables associated with the
presence of pain in individuals with FTRCT. The hypothesis is that given its complex
aetiology, no single outcome will be highly associated with pain, rather it will be important
to consider several outcomes and their interactions. Secondary objectives include: to explore
if a) baseline variables or b) a change in these variables following baseline can predict the
development of pain in individuals who initially have asymptomatic FTRCT, and to study if a)
baseline variables or b) a change in these variables following baseline can predict the
resolution of pain in individuals who initially have symptomatic FTRCT.
Methods: 40 adults with a FTRCT and shoulder pain (Symptomatic Group), and 40 adults with a
FTRCT without shoulder pain (Asymptomatic Group) will be included. They will demonstrate a
FTRCT on US examinations performed by a radiologist. Included participants will take part in
a baseline evaluation during which sociodemographic, anatomical, genetic, psychosocial, pain
sensitivity, neuromuscular and biomechanical variables will be assessed. The primary
objective (cross-sectional design) will be achieved by determining if differences between
groups are based on a sole or on several independent variables, and their relative impact on
pain (recursive partitioning, principal component analysis, MANOVA).
The secondary objectives (prospective design) will be achieved by following all participants
for 2 years. Every 3 months, the participants will complete a web-based questionnaire asking
if they have had shoulder pain. Participants in the Asymptomatic Group who develop pain and
participants in the Symptomatic Group who become pain-free will be asked to participate in a
follow-up evaluation within a week. Participants who remain pain-free in the Asymptomatic
Group and with pain in the Symptomatic Group during the follow-up period will also be asked
to participate in a follow-up evaluation at the end of the 2 years (same follow-up evaluation
for all participants, similar to baseline evaluations). Logistic regressions will be used to
identify the variables associated with pain development and with pain resolution.
Relevance: Before implementing new intervention strategies, a better understanding of factors
associated with the presence of pain is needed. By looking at different variables that could
explain pain, this project will improve our understanding of FTRCT and fill important
knowledge gaps.
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