Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06157788 |
Other study ID # |
2022-00135 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 1, 2022 |
Est. completion date |
October 1, 2023 |
Study information
Verified date |
December 2023 |
Source |
La Tour Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
In a similar study, the investigators demonstrated that shoulder stabilization could allow
the brain to partially "recover". Patients with shoulder apprehension underwent clinical and
fMRI examination before and one year after shoulder stabilization surgery. Clinical
examination showed a significant improvement in postoperative shoulder function compared with
preoperative. Coherently, results showed a decreased activation in the left pre-motor cortex
postoperatively, demonstrating that stabilization surgery induced improvements both at the
physical and at the brain levels, one year postoperatively. Most interestingly, right-frontal
pole and right-occipital cortex activity was associated with good outcome in shoulder
performance.
Description:
Fear, anxiety and anticipation of situations that could lead to a dislocation are essential
cognitive processes in shoulder apprehension. Functional magnetic resonance imaging (fMRI)
measures brain activity by detecting changes associated with blood flow. This technique
relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area
of the brain is in use, blood flow to that region also increases. Recently, investigators
used fMRI with visual apprehension stimulation to explore neuronal connections and cerebral
changes induced by shoulder dislocation. Several cerebral areas were modified during those
analyses, representing the different aspects of shoulder apprehension. Specific
reorganizations were found in apprehension-related functional connectivity of the primary
sensory-motor areas (motor resistance), dorsolateral prefrontal cortex (cognitive control of
motor behavior), and the dorsal anterior cingulate cortex/dorsomedial prefrontal cortex and
anterior insula (anxiety and emotional regulation).
Those regions are involved in the cognitive control of motor behavior. Hence, there is a
motor control anticipation and muscular resistance (protective reflex mechanism), in order to
avoid shoulder movement that could lead to dislocation. Another recent study published by
Shitara et al. analyzed cerebral changes induced by shoulder dislocation in 14 patients.
Although results were similar to the investigators' study, they observed a larger and less
specific spectrum of activated cerebral areas, that may be explained by the fact that they
projected static and abstract images during fMRI acquisition that may be prone to vaguer and
subjective interpretation, and that moreover did not convey the dynamic component inherent to
apprehension. In a subsequent study, investigators extended these findings by investigating
further structural alterations in patients with shoulder apprehension. The investigators
found that fractional anisotropy, representing white matter integrity, was increased in the
left internal capsule and partially in the thalamus of studied patients compared to healthy
controls. Fractional anisotropy correlated positively with pain visual analogue scale (VAS)
scores (p < .05) and negatively with simple shoulder test (SST) scores (p < .05). This
suggests an abnormal increased axonal integrity and therefore pathological structural
plasticity due to the over-connection of white matter fibers in the motor pathway. These
structural alterations affect several dimensions of shoulder apprehension as pain perception
and performance in daily life.
The neuronal changes previously mentioned and presented in shoulder apprehension can also be
assessed in daily clinical practice. Indeed, Cunningham et al. correlated clinical scores and
tests (Rowe, pain VAS, SST, subjective shoulder value (SSV), WOSI) with functional cerebral
imaging in patients with shoulder apprehension. Their hypothesis was that it might be
possible to simplify shoulder instability scores as it has been previously possible with
rotator cuff and SLAP lesions, and that at least one score could encompass the spectrum of
these cerebral alterations. They found that the Rowe score integrated several aspects of
apprehension, notably the motor and sensory functions, as well as pain anticipation and
attention. This could be explained by the fact that the Rowe score is the only tested score
that integrates range of motion. This also provides the ability to evaluate motor component
(stability and motion) and cognitive component (perceived pain) of shoulder apprehension.
Pain VAS and WOSI seemed to correlate with less brain networks compared to the Rowe. This
could be explained by the fact that their assessment is focused only on cognitive aspects
(pain for pain VAS, shoulder function in everyday life activities for WOSI), and that they do
not integrate pure shoulder motion. SST and SSV were not found to be associated with brain
network alterations, which is corroborated by the fact that they are general shoulder scores
and were not specifically validated for instability.
In a similar study, the investigators demonstrated that shoulder stabilization could allow
the brain to partially "recover". Patients with shoulder apprehension underwent clinical and
fMRI examination before and one year after shoulder stabilization surgery. Clinical
examination showed a significant improvement in postoperative shoulder function compared with
preoperative. Coherently, results showed a decreased activation in the left pre-motor cortex
postoperatively, demonstrating that stabilization surgery induced improvements both at the
physical and at the brain levels, one year postoperatively. Most interestingly, right-frontal
pole and right-occipital cortex activity was associated with good outcome in shoulder
performance.