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

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.

Conditions

• Shoulder Pain

Interventions

DEVICE

Immersive Virtual Reality

Participants in the experimental group will follow a treatment program that combines standard care with an immersive virtual reality (IVR) intervention. During the first 4 weeks, participants will undergo the IVR intervention, followed by the same standard treatment as the control group for the subsequent 8 weeks. IVR Intervention Protocol: Sessions and Equipment: Participants will attend up to 12 IVR sessions using a head-mounted device (HMD), the Meta Quest III, equipped with a hand-tracking system (Meta VR, Facebook, California) to enable interaction with the therapeutic software Dynamics PainRehab (Dynamics VR Rehab, Seville, Spain). The Meta Quest III HMD is chosen for its commercial availability, widespread use, minimal visual latency, and user-friendly interface. The software application, "Hombro PainRehab," features multisensory inputs (vision and sound), high-quality graphics, head and hand tracking, and provides a highly immersive experience. The IVR intervention incorporate

PROCEDURE

Exercise

Participants assigned to the control group will receive standard treatment for rotator cuff-related shoulder pain. This will consist of standardized therapeutic exercise performed for 25 minutes, 3 times per week, over a 12-week period. The exercise regimen will be individualized based on intensity, utilizing the Rate of Perceived Exertion (RPE) scale, with the goal of achieving intensity levels of 6-8 on a scale of 0 to 10.

Sponsors & Collaborators

• Universidad Francisco de Vitoria

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-01

Primary Completion

2026-04-28

Completion

2026-04-28

Countries

• Spain

Study Locations