CompletedNot Applicable

Effectiveness of Immersive Virtual Reality on Biomarkers and Clinical and Clinimetric Variables in Patients With Persistent Shoulder Pain

Spain44 participantsStarted 2025-03-01

Plain-language summary

Shoulder pain is one of the primary reasons for seeking physiotherapy care. The high prevalence of rotator cuff-related shoulder pain underscores the need for research into novel treatment approaches that may enhance the clinical outcomes of conventional physiotherapy interventions. Immersive Virtual Reality (IVR) has been demonstrated to serve as an effective adjunct for pain management by providing distraction and altering patients' pain perception. Specifically, when used alongside exercise, IVR has been shown to induce hypoalgesia in individuals with chronic low back pain. Additionally, IVR is emerging as a promising tool to enhance motivation and improve adherence to rehabilitation protocols, which is critical for long-term treatment implementation and achieving positive outcomes. These findings suggest that virtual reality may provide an innovative approach to managing pain in patients with rotator cuff-related shoulder pain, improving their pain experience, functionality, and quality of life. To date, no study has directly compared the effectiveness of combining IVR with standard physiotherapy treatments versus standard treatments alone on clinical variables, clinimetric measures, and biomarkers in individuals with persistent shoulder pain related to the rotator cuff. Therefore, conducting a randomized multicenter clinical trial on this subject, facilitated by international collaboration among RIU-affiliated universities, could provide a robust foundation for implementing new technologies such as virtual reality in pain management and advancing rehabilitation strategies. The objective of this project is as follows: To compare the effectiveness of combining immersive virtual reality with standard physiotherapy treatment versus standard treatment alone on clinical variables, clinimetric measures, and biomarkers in individuals with persistent rotator cuff-related shoulder pain.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18 and 70 years. * Shoulder pain persisting for at least six months. * Presence of shoulder pain during movement. * Clinical diagnosis of rotator cuff-related shoulder pain. * Willingness to participate in the study and signing of informed consent. Exclusion Criteria * Shoulder pain related to cervical spine conditions. * Presence of pain in the elbow, wrist, and/or hand. * Clinical diagnosis of frozen shoulder. * Clinical diagnosis of shoulder instability. * Cognitive impairments. * Concomitant physiotherapy treatments during the study period. * History of trauma associated with the onset of shoulder pain. * Previous fractures in the affected shoulder. * Prior surgeries in the affected shoulder. * Use of analgesic or anti-inflammatory medications within 24 hours prior to study participation. Presence of rheumatic or neurological diseases.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.