Understanding Control and Mechanisms of Shoulder Instability in FSHD

NCT05239520 | Completed

• 3 other identifiers: UoL001656RPG185Robert Jones & Agnes Hunt site
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Pain; Neuromuscular Diseases; Shoulder Injuries; Facio-Scapulo-Humeral Dystrophy; Upper Extremity Problem

Keywords

Biomechanics; Human movement analysis; Electromyography; Ultrasound

Outcome Measures

Primary Outcomes (5)

• Kinematic features of movement: joint angles (degrees)

  Range of movement values and associated derivatives will be reported for the associated movement tasks.

  Day 1

• Kinematic features of movement: displacement (mm)

  Displacement values and associated derivatives will be reported for associated movement tasks.

  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.

  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.

  Day 1

• Ultrasound imaging: Muscle architecture parameters (mm)

  Muscle architecture parameters where possible (Muscle thickness)

  Day 1

Study Arms (2)

People affected by FSHD

Participants with a diagnosis of FSHD. 3D movement analysis session including surface electromyography and Ultrasound.

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

Other: 3D movement analysis with surface electromyography and ultrasound

Interventions

3D movement analysis with surface electromyography and ultrasound OTHER

Single measurement session of 3D movement analysis with surface electromyography for upper limb movements and ultrasound measurements of upper muscles

Age matched control group; People affected by FSHD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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
• \- People aged 18 years and older
• Any previous presentation to a health care professional with a diagnosis of shoulder instability
• 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

Sponsors & Collaborators

• University of Liverpool: lead
• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: collaborator
• Bournemouth University: collaborator
• Keele University: collaborator

Study Sites (1)

Robert Jones & Agnes Hunt Orthopaedic Hospital

Oswestry, Gobowen, SY10 7AG, United Kingdom

Location

MeSH Terms

Conditions

Shoulder Pain; Neuromuscular Diseases; Shoulder Injuries; Muscular Dystrophy, Facioscapulohumeral

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Wounds and Injuries; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 15, 2022
• Study Start: March 25, 2022
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

GB (1)