Virtual Reality Intervention in Patients With Persistent Shoulder Pain

For many people the long-term disability associated with musculoskeletal disorders (MSK) is substantial. Within this group of conditions, musculoskeletal shoulder problems are ubiquitous. They impact on sleep, social interaction, ability to perform activities of daily living, sporting participation, and work. The prevalence of MSK shoulder disorders is reported to range from 0.7% to 55.2%, with the incidence ranging from 7.7 to 62.0 per thousand people per year. For people older than 65 years of age, more than 30 per cent experience shoulder pain and disability daily. These shoulder complaints encompass among others rotator cuff related shoulder pain (RCRSP), instability of the glenohumeral joint and frozen shoulders. Pharmacological, surgical, and non-surgical interventions are used in the management of persistent shoulder pain conditions, however, all current interventions for persistent shoulder conditions are associated with, at best, modest clinical effects. This limited efficacy may be attributed to several factors such as poor engagement and adherence to exercise and advice, unhelpful sickness beliefs ("the tendons will snap if I elevate the arm") and unhelpful coping strategies (fear of movement, protective movements, catastrophic thinking). These limitations highlight the need for novel, comprehensive treatment approaches that address both the physical and psychological aspects of persistent shoulder pain while promoting patient engagement and adherence.

Extended reality (XR) is an existing technology that is being increasingly integrated for use in healthcare. XR is being used for patient education, various physical, and psychological conditions, as well as pain conditions. It is being used in the management of anxiety disorders, posttraumatic stress disorders, cardiorespiratory disease, neurological disorders, and musculoskeletal conditions. Initially used in the gaming industry, different XR technologies have been rapidly introduced in various areas of healthcare. XR, which encompasses a continuum of realities such as Augmented Reality (AR), Mixed Reality (MR), and Immersive Virtual Reality (iVR) represents different forms of the technology. While AR and MR maintain a connection to the real world by overlaying or integrating virtual elements, immersive VR creates a fully immersive digital environment that replaces the real-world with an illusionary digital world, typically introduced within head-mounted-displays (HMDs).

XR has been shown to be effective in acute and persistent pain conditions such as painful medical procedures and wound care, knee and hip osteoarthritis, persistent low back pain, and shoulder pain. The mechanisms by which XR and especially iVR may decrease pain and disability are not fully elucidated but may be due to distraction and attentional shifting, manipulation of sensory input through multisensory feedback and embodiment that potentially alters body perception. Virtual environments encourage movement by allowing patients to move without being cognizant of how they move, how far they move, the complexity of movement, or the speed at which they move. This may enhance new movement strategies and encourage the restoration of normal movements (less guarded or protective movement). By violating negative expectations of movement34 and decreasing fear of movement, range of motion and function may be improved, and pain levels may decrease. Furthermore, VR has been reported to be engaging, enjoyable, and associated with positive feelings allowing for an increase in participation and adherence to exercise therapy.

Despite the growing interest in iVR for musculoskeletal rehabilitation, there is a notable gap in the literature regarding its application and effectiveness specifically for persistent shoulder pain. Given the evolving nature and contextual sensitivity of virtual reality (VR) interventions, this study follows the recommendation by Birckhead et al, who argue for a hypothesis-generating and exploratory approach in early-stage VR research, rather than premature large-scale randomized trials. VR is a complex, multicomponent intervention whose effectiveness likely depends on interactions between individual characteristics, contextual factors, and specific features of the technology. A purely quantitative approach might not be able to elucidate the complexities of how and why it may (or may not) work for different patients. The investigators will therefore perform a mixed-methods feasibility design, in which quantitative assessment focusing on Bowen's feasibility areas acceptability, demand, and preliminary efficacy is combined with Realist evaluation. The Realist evaluation is a theory-driven approach that seeks to understand not only whether an intervention works, but for whom, under what circumstances, and through which mechanisms. An initial initial program theory will be developped based on literature and expert input, expressed as context-mechanism-outcome configurations. The theory will then be tested through qualitative realist interviews. This allows for generating a program theory for the VR intervention and will inform both the refinement of the intervention and the design of future confirmatory trials, aligned with the UK Medical Research Council (MRC) Framework for Complex Interventions.

2. OBJECTIVES

Primary Objective:

To evaluate the feasibility in terms of acceptability, demand, and preliminary efficacy of a six-week homebased iVR intervention in patients with persistent shoulder complaints.

The recommendations for the design of a feasibility study of Bowen et al will be followed, exploring the following areas of focus of feasibility: 1) acceptability, 2) demand and 3) preliminary efficacy.

1) Focus area 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 4. usability and acceptance of the iVR intervention using the Virtual Reality System Usability Questionnaire

2) Focus area of demand:

1. 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.

3) Focus area of preliminary efficacy:

1. Pain: (NRS 0-10) for pain during the last 24h, pain at rest and pain at night
2. Disability: Shoulder Pain and Disability Index (SPADI)
3. Fear of movement: Tampa Scale for Kinesiophobia (TSK -11)
4. Illness perceptions: Brief Illness Perception Questionnaire (B-IPQ),
5. Sleep quality: Sleep Quality Scale (SQS).

Secondary Objective(s):

To explore the perceived underlying mechanisms of VR outcomes by developing an initial program theory (CMO's) and refine the initial theory through collecting data by means of focus group interviews of participating physiotherapists and patients.

Explored items will be:

• To assess how different contexts (patient, physiotherapist, and environmental factors) influence the acceptability, demand, and efficacy of the VR intervention.
• To explore the mechanisms by which immersive VR may (or may not) lead to reductions in pain, disability, fear of movement, or poor sleep.
• To identify patterns of outcomes across subgroups of patients and contexts, thereby refining the initial program theory of how VR works for persistent shoulder complaints.