Shoulder PainNCT05239520
Understanding Control and Mechanisms of Shoulder Instability in FSHD
An observational study of Shoulder Pain and Neuromuscular Diseases, run by University of Liverpool at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain, Neuromuscular Diseases, Shoulder Injuries
- What is being tested?
- 3D movement analysis with surface electromyography and ultrasound
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Mar 2022to 21 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will consist of people aged 18 years of age and older. The two groups will include people with (people affected by FSHD) and without FSHD (age matched controls).
Who may be able to join
- Stratified groups
- Able to lift arms above shoulder height (n=3)
- Unable to lift arms above shoulder height (n=2)
- Post Scapulothoracic shoulder arthrodesis (n=2)
- Diagnosed with FSHD
- Aged 18 years and older
- People aged 18 years and older
Who cannot join
- Recent trauma to the shoulder within the last 3 months on the arm being assessed that has not resolved
- Recent surgery to the thorax or upper limb in the last 6 months
- Previous history of fracture to the shoulder joint being assessed
- Co-existing neurological pathologies or additional musculoskeletal injuries to the upper limb being assessed
- Age Matched Controls
- Any previous presentation to a health care professional with a diagnosis of shoulder instability
Show all 10Show fewer
- Previous shoulder injury within the last 3 months on the arm being assessed that has not resolved
- Any co-existing neurological pathologies or deficits
- Any previous surgical intervention on the arm being assessed
- Currently undergoing or awaiting medical management, diagnostic investigations or rehabilitation on the arm being assessed
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Robert Jones & Agnes Hunt Orthopaedic Hospital
Oswestry, Gobowen, SY10 7AG
About this study
Official title: Understanding Control and Mechanisms of Shoulder Instability in Patients With Facioscapulohumeral Muscular Dystrophy (FSHD)
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.
Read the detailed 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.
- Conditions
- Shoulder Pain, Neuromuscular Diseases, Shoulder Injuries, Facio-Scapulo-Humeral Dystrophy, Upper Extremity Problem
- Being tested
- 3D movement analysis with surface electromyography and ultrasound
- Keywords
- Biomechanics, Human movement analysis, Electromyography, Ultrasound
- Medical subject headings
- Shoulder Pain, Neuromuscular Diseases, Shoulder Injuries, Muscular Dystrophy, Facioscapulohumeral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D movement analysis with surface electromyography and ultrasoundOther
Single measurement session of 3D movement analysis with surface electromyography for upper limb movements and ultrasound measurements of upper muscles
| Study group | Role | What they receive |
|---|---|---|
| People affected by FSHD | Participants with a diagnosis of FSHD. 3D movement analysis session including surface electromyography and Ultrasound. Receives: Other: 3D movement analysis with surface electromyography and ultrasound | |
| Age matched control group | Participants without a diagnosis of FSHD. 3D movement analysis session including surface electromyography and Ultrasound Receives: Other: 3D movement analysis with surface electromyography and ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic features of movement: joint angles (degrees)
Range of movement values and associated derivatives will be reported for the associated movement tasks.
Measured: Day 1
Kinematic features of movement: displacement (mm)
Displacement values and associated derivatives will be reported for associated movement tasks.
Measured: Day 1
Kinetic variables related to the movement tasks: Force (Nm)
Force values for the strength testing, joint contact and muscle force values will be reported for associated movement tasks.
Measured: Day 1
Muscle activity patterns related to the movement tasks: Surface electromyography (mv)
Muscle activity patterns related to the movement tasks will be reported for associated movement tasks.
Measured: Day 1
Ultrasound imaging: Muscle architecture parameters (mm)
Muscle architecture parameters where possible (Muscle thickness)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start25 Mar 2022
- Primary completion21 Oct 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust, Bournemouth University, Keele University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239520
- Sponsor's protocol ID
- UoL001656
- Other IDs
- RPG185, Robert Jones & Agnes Hunt site
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymised final trial dataset and anonymised 3D movement data files will be stored on the University of Liverpool data repository. The anonymised dataset associated with the University of Liverpool data repository will be assigned a Digital object identifier and will be openly available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Control and Mechanisms of Shoulder Instability in Patients With Facioscapulohumeral Muscular Dystrophy (FSHD)
- ClinicalTrials.gov ID
- NCT05239520
- Acronym / sponsor ID
- UoL001656
- Conditions
- Shoulder Pain, Neuromuscular Diseases, Shoulder Injuries, Facio-Scapulo-Humeral Dystrophy, Upper Extremity Problem
- Keywords
- Biomechanics, Human movement analysis, Electromyography, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust, Bournemouth University, Keele University
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People affected by FSHD | – | Other: 3D movement analysis with surface electromyography and ultrasoundParticipants with a diagnosis of FSHD. 3D movement analysis session including surface electromyography and Ultrasound. |
| Age matched control group | – | Other: 3D movement analysis with surface electromyography and ultrasoundParticipants without a diagnosis of FSHD. 3D movement analysis session including surface electromyography and Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will consist of people aged 18 years of age and older. The two groups will include people with (people affected by FSHD) and without FSHD (age matched controls).
Key inclusion criteria (7 listed)
- Stratified groups
- Able to lift arms above shoulder height (n=3)
- Unable to lift arms above shoulder height (n=2)
- Post Scapulothoracic shoulder arthrodesis (n=2)
- Diagnosed with FSHD
Key exclusion criteria (10 listed)
- Recent trauma to the shoulder within the last 3 months on the arm being assessed that has not resolved
- Recent surgery to the thorax or upper limb in the last 6 months
- Previous history of fracture to the shoulder joint being assessed
- Co-existing neurological pathologies or additional musculoskeletal injuries to the upper limb being assessed
- Age Matched Controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D movement analysis with surface electromyography and ultrasoundSingle measurement session of 3D movement analysis with surface electromyography for upper limb movements and ultrasound measurements of upper muscles | Other | Age matched control group, People affected by FSHD |
Primary outcome
Kinematic features of movement: joint angles (degrees)
Time frame: Day 1
Range of movement values and associated derivatives will be reported for the associated movement tasks.
Kinematic features of movement: displacement (mm)
Time frame: Day 1
Displacement values and associated derivatives will be reported for associated movement tasks.
Kinetic variables related to the movement tasks: Force (Nm)
Time frame: Day 1
Force values for the strength testing, joint contact and muscle force values will be reported for associated movement tasks.
Muscle activity patterns related to the movement tasks: Surface electromyography (mv)
Time frame: Day 1
Muscle activity patterns related to the movement tasks will be reported for associated movement tasks.
Ultrasound imaging: Muscle architecture parameters (mm)
Time frame: Day 1
Muscle architecture parameters where possible (Muscle thickness)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: Yes. The anonymised final trial dataset and anonymised 3D movement data files will be stored on the University of Liverpool data repository. The anonymised dataset associated with the University of Liverpool data repository will be assigned a Digital object identifier and will be openly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain and Neuromuscular Diseases, run by University of Liverpool at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematic features of movement: joint angles (degrees) (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.