Virtual Reality Intervention in Patients With Persistent Shoulder Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorHAN University of Applied Sciences

About this trial

Shoulder pain is very common and can make daily activities difficult. Many people have shoulder pain for a long time, even after treatment. Common shoulder problems include pain from the shoulder muscles and tendons, a frozen shoulder, or an unstable shoulder. Unfortunately, both surgery and physiotherapy often help only a little. This can be due to many reasons, such as people not continuing their exercises, fear of moving the shoulder, incorrect beliefs about pain, other health problems, or lifestyle factors.

Virtual Reality (VR) is a new and promising technology that is already being used to help people with long-lasting pain. By using a VR headset, people can exercise in a motivating and engaging virtual environment. VR may help reduce fear of movement, improve how people feel about their body, make movement easier, and help people stick to their exercises. However, there is still very little research on using VR for long-lasting shoulder pain.

The goal of this study is to find out whether a home-based VR exercise program for people with ongoing shoulder complaints is practical and acceptable. The investigators want to know if people are willing and able to use VR at home, whether they continue the treatment, and whether it shows early signs of reducing pain and limitations. They also want to understand who benefits most from VR, in which situations it works best, and why it may or may not help.

People aged 16 years and older who have had shoulder pain and limitations for more than three months can take part. This includes people with shoulder tendon-related pain, frozen shoulder, or shoulder instability.

The study lasts six weeks and includes three parts. First, participants receive online educational videos about shoulder pain and movement. Second, they take part in three physiotherapy sessions: one in person and two online. Third, participants use a VR headset at home every day for about 15 minutes to perform guided shoulder and whole-body exercises, such as reaching or aiming tasks. The exercises gradually become more challenging. Participants receive clear written and video instructions, and technical support is available if needed.

During the study, participants will complete questionnaires and the VR system will record basic usage data. At the end of the study, group interviews will be held with participants and physiotherapists to talk about their experiences with VR and how it influenced pain, movement, and daily activities.

Using VR is considered safe. Some people may experience mild and short-lasting side effects, such as dizziness, but serious problems are not expected. The main effort for participants is the time spent on exercises and completing questionnaires.

The results of this study will help determine whether VR is a useful and realistic treatment option for people with long-lasting shoulder pain and will guide future, larger studies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Unilateral shoulder pain NPRS ≥ 4/10, persisting longer than 3 months

Adults ≥ 16 years old

Willing and able to comply with study protocol

Diagnosis of rotator cuff related shoulder pain, or shoulder instability, or frozen shoulder, confirmed according to international clinical guidelines

Disqualifiers

Neurological disease affecting the shoulder

Shoulder stiffness not consistent to frozen shoulder

Pain in the shoulder that is elicited by movements of the head and neck.

history of motion-sickness

Trial design

Design model

Single group

Treatments tested in this trial

  • Exercise with Virtual reality

    Other intervention

    Participants exercise their shoulder at home with a VR headset, provided by the research team. The physiotherapist explains how to use the headset and wich applicatiosn should be used at which level. participants exercise daily 10 minutes for six weeks.

  • education on shoulder pain

    Other intervention

    participants receive a video-clip of 3 minutes that explains their shoulder condition.

  • simulation de-briefing

    Other intervention

    During the physiotherapy conultation, participants will be video-recorded with their own mobile device, when moving within VR. After thtat, the phyiotherapist and participant engage in a simulation de-briefing, discussing how it felt to move within VR, any changes in perceptions on pain and movement are discussed as well as the transfer to other movements in daily life.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: VR intervention armExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

The outcome measure belongs to the following areas of focus of feasibility 1) acceptability

acceptability: 1. recruitment rate defined as the number of participants who give their consent to the orthopaedic surgeon for an appointment with the research team to screen for eligibility 2. participation rate defined as the number of participants enrolled in the study divided by the number of eligible individuals approached 3. drop-out rate defined as the proportion of participants who discontinue the study before completing the 6-week VR program 3\. rate of response to questionnaires defined as the number of fully completed questionnaires at baseline and follow-up

Time frame
From enrollment to the end of the treament 7 weeks

Secondary outcomes

Other outcomes

1

Focus area of demand: adherence

adherence to study protocol by physiotherapists and patients: data collection via system logs of VR headsets (frequency of use, total time spent in VR) and data collected in focus group interviews.

Time frame
7 weeks
2

Focus area of preliminary efficacy: pain

Pain: (NRS 0-10) for pain during the last 24h, pain at rest and pain at night

Time frame
8 weeks
3

Focus area of preliminary efficacy:

Disability: Shoulder Pain and Disability Index (SPADI)

Time frame
8 weeks
4

Focus area of preliminary efficacy

Fear of movement: Tampa Scale for Kinesiophobia (TSK -11)

Time frame
8 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HAN University of Applied Sciences

Lead sponsor

Netherlands Organisation for Scientific Research

Collaborator

This trial is not recruiting at the moment. You can still explore other options: