About this trial
People with long-term (chronic) shoulder disorders caused by injuries, overuse or conditions (such as arthritis) often need physiotherapy. This usually includes exercise therapy to help reduce pain, rebuild strength and make every day activities easier. However, it can be hard to stick to an exercise programme. People may stop due to pain, fear of making the symptoms worse or simply loosing motivation.
Virtual Reality (VR) is a technology that may help people say engaged with their exercise programmes by making exercises more enjoyable and interactive. When using a headset (similar to goggles), people can see and interact with a 3D virtual world. Their movement, especially their hands and arms, are shown as an 'avatar' (a virtual character) in this virtual world. Exercise can feel more like playing a game or engaging with tasks/challenges, rather than performing repetitive movements. This shift might help reduce focus on pain and increase motivation. VR also provides real-time feedback, helping people track their progress and adjust their movements instantly. This might lead to more accurate and consistent exercise performance and better recovery outcomes.
Before we can test whether VR exercise programmes are effective for people with chronic shoulder disorders, we firstly need to understand whether it is practical and acceptable for patients to use. This 'feasibility' study will therefore involve 20 patients with chronic shoulder disorders referred for physiotherapy at the Royal National Orthopaedic Hospital (RNOH) in Stanmore, United Kingdom. Participants will take part in three VR exercise sessions at the RNOH over a three-week period. Levels of pain, quality of life and sleep quality etc. will be measured before and after three weeks. Interviews will also be held up to two weeks after the final session to explore people's experiences and thoughts towards the VR exercise programme. The results will help us decide if a larger study should go ahead.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients >18 years with diagnosed unilateral/ bilateral shoulder pain with/ without co-existing symptoms of instability and or stiffness (persisting > three months) generated from a Musculoskeletal origin
Patients who have been referred for conservative management
New or follow-up patients
Sufficient English to understand written materials/verbal instruction/or accompanied by family/friends able to translate
Disqualifiers
Unable to provide informed consent
On a waiting list for surgery and/or injections
Referred for post-operative physiotherapy
Shoulder pain not originating from an MSK aetiology (such as hemiplegia or peripheral nerve injury)
Trial design
Single group
Treatments tested in this trial
Virtual Reality
DeviceParticipants will engage with a 30 minute shoulder exercise programme using the SyncVR platform. There will be three intervention sessions in total and they will be spaced out once per week for a period of three weeks.
Treatment groups
Trial outcomes
Primary outcomes
Consent rate
The consent rate will be used as a measure of recruitment and will be defined as the number of participants who provide informed consent divided by the total number of patients screened for eligibility, ie: number of people who consented/number of people approached) x 100.
Dropout rate
The dropout rate will be defined as the percentage of participants who started the study, but did not complete all three treatment visits.
Secondary outcomes
Pain Intensity - Numeric Pain Rating Scale (NPRS)
The NPRS is a validated, 11-item unidimensional numerical rating scale, with 0 representing 'no pain' and 10 representing 'worst imaginable pain' in the past 24 hours.
Shoulder Range of Movement
Shoulder ROM will be measured using a validated self-assessment questionnaire published by Yang et al 2015.
Disability - Shoulder Pain and Disability Index (SPADI)
The SPADI is a validated, self-administered questionnaire involving two dimensions (pain and functional activities) and 13 items. Scores can range between 0-100, where higher scores indicate worsening disability.
Quality of Life - EuroQol- 5 Dimension (EQ-5D-3L)
The EQ-5D-5L is a widely used, validated measure of health-related quality of life in terms of 5 dimensions (mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, anxiety and depression), each with 5 levels of severity.
Sponsors and contacts
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Royal National Orthopaedic Hospital NHS Trust
Lead sponsor
SyncVR Medical
Collaborator
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