Virtual Reality Intervention in Patients With Persistent Shoulder Pain

NCT07390227 | Not Yet Recruiting DMC

• 1 other identifier: ECO 721.11/25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Instability; Rotator Cuff Syndrome; Frozen Shoulder

Keywords

Virtual reality; Shoulder; persitent shoulder pain

Outcome Measures

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

  From enrollment to the end of the treament 7 weeks

Other Outcomes (6)

• Focus area of demand: adherence

  7 weeks

• Focus area of preliminary efficacy: pain

  8 weeks

• Focus area of preliminary efficacy:

  8 weeks

Study Arms (1)

VR intervention arm

EXPERIMENTAL

the intervention consists of educational video's, a simulation debriefing and VR exercises at home.

Other: Exercise with Virtual reality; Other: education on shoulder pain; Other: simulation de-briefing

Interventions

simulation de-briefing OTHER

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.

VR intervention arm

Exercise with Virtual reality OTHER

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.

VR intervention arm

education on shoulder pain OTHER

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

VR intervention arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. RC related shoulder pain
• shoulder pain and/or weakness during active or resisted shoulder external rotation, and or, shoulder elevation and/or
• Presence of Painful arc during elevation
• \. shoulder instability
• Radiographically, computed tomography scans, magnetic resonance imaging scans confirmed dislocation or
• Documented history of manual or surgical relocation of the shoulder
• Traumatic onset with persistent symptoms
• Positive apprehension sign (fear of imminent dislocation when the arm is placed in abduction and external rotation during clinical examination)
• \. frozen shoulder
• Restricted active and passive range of shoulder movement in all directions
• Restricted active and passive shoulder external rotation of 50 percent compared to non-painful arm

You may not qualify if:

• 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
• history of seizures
• severe vertigo or vestibular impairment.

Sponsors & Collaborators

• HAN University of Applied Sciences: lead
• Netherlands Organisation for Scientific Research: collaborator

Study Sites (1)

HAN

Nijmegen, 6525 EN, Netherlands

Location

Related Publications (8)

• Rossettini G, Colombi A, Carlino E, Manoni M, Mirandola M, Polli A, Camerone EM, Testa M. Unraveling Negative Expectations and Nocebo-Related Effects in Musculoskeletal Pain. Front Psychol. 2022 Mar 16;13:789377. doi: 10.3389/fpsyg.2022.789377. eCollection 2022.

  PMID: 35369173 RESULT

• Matamala-Gomez M, Diaz Gonzalez AM, Slater M, Sanchez-Vives MV. Decreasing Pain Ratings in Chronic Arm Pain Through Changing a Virtual Body: Different Strategies for Different Pain Types. J Pain. 2019 Jun;20(6):685-697. doi: 10.1016/j.jpain.2018.12.001. Epub 2018 Dec 16.

  PMID: 30562584 RESULT

• de Vries FS, van Dongen RTM, Bertens D. Pain education and pain management skills in virtual reality in the treatment of chronic low back pain: A multiple baseline single-case experimental design. Behav Res Ther. 2023 Mar;162:104257. doi: 10.1016/j.brat.2023.104257. Epub 2023 Jan 18.

  PMID: 36731183 RESULT

• Alvarez de la Campa Crespo M, Donegan T, Amestoy-Alonso B, Just A, Combalia A, Sanchez-Vives MV. Virtual embodiment for improving range of motion in patients with movement-related shoulder pain: an experimental study. J Orthop Surg Res. 2023 Sep 26;18(1):729. doi: 10.1186/s13018-023-04158-w.

  PMID: 37752613 RESULT

• Caneiro JP, Smith A, Bunzli S, Linton S, Moseley GL, O'Sullivan P. From Fear to Safety: A Roadmap to Recovery From Musculoskeletal Pain. Phys Ther. 2022 Feb 1;102(2):pzab271. doi: 10.1093/ptj/pzab271.

  PMID: 34971393 RESULT

• Clausen MB, Merrild MB, Holm K, Pedersen MW, Andersen LL, Zebis MK, Jakobsen TL, Thorborg K. Less than half of patients in secondary care adheres to clinical guidelines for subacromial pain syndrome and have acceptable symptoms after treatment: A Danish nationwide cohort study of 3306 patients. Musculoskelet Sci Pract. 2021 Apr;52:102322. doi: 10.1016/j.msksp.2021.102322. Epub 2021 Jan 12.

  PMID: 33485212 RESULT

• Page MJ, Green S, McBain B, Surace SJ, Deitch J, Lyttle N, Mrocki MA, Buchbinder R. Manual therapy and exercise for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012224. doi: 10.1002/14651858.CD012224.

  PMID: 27283590 RESULT

• GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.

  PMID: 28919117 RESULT

Related Links

• this page describes the whole research project on VR in shoulder rehabilitation

MeSH Terms

Conditions

Bursitis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bart Staal, PhD

  HAN University of Applied Sciences

  STUDY DIRECTOR

Central Study Contacts

Beate Dejaco, MSc

CONTACT

0031622379871; beate.dejaco@han.nl

Niki Stolwijk, PhD

CONTACT

niki.stolwijk@han.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator at department Key Factors in Physical Activity and Rehabilitation Care

Model Details: Feasibility study

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: February 5, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: after completion of the study
• Access Criteria: IPD are available at the previous mentioned DOI at the Radboud Data Repository. Data From the qualitative part of the study will only have restricted access.

Locations

NL (1)