Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05239520 |
| Other study ID # |
UoL001656 |
| Secondary ID |
RPG185Robert Jon |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 25, 2022 |
| Est. completion date |
October 21, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
University of Liverpool |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of this study is to identify factors for shoulder instability in people with
Facioscapulohumeral dystrophy (FSHD). FSHD is a non-life limiting condition with symptoms
presenting in the second decade of life (Evangelista et al., 2016). Between 2500 to 3000
people are diagnosed with FSHD in the UK and it is the third most common dystrophy. The
overall prevalence is 1: 20,000 and on average 52 people are newly diagnosed with FSHD each
year (Emery, 1991; Padberg et al., 1995; UK, 2020) As the disease progresses, patients lose
the ability to adequately control muscles around the shoulder girdle, possibly contributing
to the development of shoulder instability i.e. partial or complete dislocation of the
shoulder joint (Bergsma, Cup, Geurts, & De Groot, 2015; Bergsma, Cup, Janssen, Geurts, & de
Groot, 2017; Mul et al., 2016). Loss of control around the shoulder is also thought to
contribute to pain and a reduced capacity to perform tasks above shoulder height.
Additionally, the development of fatigue and chronic pain further limit patient's abilities
and engagement with rehabilitation.
If we better understand the mechanisms associated with instability, we can better target
physiotherapy interventions to improve rehabilitation. If we identify specific patterns of
activity associated with instability, these could be addressed through personalised and
improved exercise prescription and rehabilitation. Additionally, we may identify causes of
instability for which physiotherapy or exercise programmes may not be appropriate, therefore
ensuring patients are referred to the correct service in a timely manner, improving patient
outcomes and allocating resources more appropriately.
Description:
Shoulder instability in Facioscapulohumeral dystrophy (FSHD) is a significant problem, with
over 80% of patients reporting that it affects their ability to perform activities of daily
living (Faux-Nightingale , 2021). The underlying mechanisms of shoulder instability in FSHD
are not well understood. It is thought that instability at the shoulder subsequently
contributes to the development of shoulder pain and progressive loss of function,
particularly during tasks performed above head height. Despite a large proportion of patients
reporting shoulder instability that affects function, only 50% report engaging in some form
of upper limb rehabilitation (Faux-Nightingale , 2021).
Both surgical and nonsurgical interventions are based on a current understanding of the
associated mechanisms that may include muscle wasting, weakness, changes to the structure of
the muscle tissue or inappropriate muscle coordination (Bergsma et al., 2014). As there is no
cure for FSHD, rehabilitation is fundamental in the management of the condition. Overall,
rehabilitation strategies are aimed at maintaining existing levels of function, avoiding
complications associated with progression of the disease and targeting mechanisms associated
with the development of instability. e.g. exercises to improve co-ordination of the shoulder
muscles if the source of instability is dysfunctional muscle control.
Rehabilitation in patients with FSHD is complex and it is therefore important that
rehabilitation is appropriately targeted. There is limited evidence to support the
effectiveness of existing rehabilitation strategies in FSHD. In order for rehabilitation to
be appropriately allocated disease mechanisms should be understood. Existing mechanisms of
shoulder instability in FSHD are not well understood and may explain why more than 50% of
patients are not engaging in any form of upper limb rehabilitation.
Shoulder stability results from complex mechanisms comprising of finely balanced forces in
ligaments, muscles and joint surfaces (Ameln, Chadwick, Blana, & Murgia, 2019). Currently, we
are unable to capture this complexity to quantify instability during dynamic upper limb tasks
performed during clinical assessment and rehabilitation (Marchi, Blana, & Chadwick, 2014).
Biomechanical or mathematical modelling of this complex structure can help to understand the
mechanisms associated with instability and predict outcomes for surgical and non-surgical
interventions (Arnold, Liu, Ounpuu, Swartz, & Delp, 2006; Delp et al., 2007; Laracca,
Stewart, Postans, & Roberts, 2014). Loading on internal structures that cannot be measured
can also be estimated by this approach.
This project is therefore a fundamental step, in the development of biomechanical models
which can ultimately be used to further our understanding of the shoulder, specifically
behaviour of the articulating bony surfaces and muscle forces. In this application we hope to
identify mechanisms for shoulder instability which may help better inform rehabilitation and
surgical decision making in the management of FSHD.
