- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07592156
Immersive Virtual Reality Versus Conventional Physiotherapy for Shoulder Tendinopathy (HOMVR)
Efficacy of Immersive Virtual Reality Compared With Conventional Physiotherapy in the Management of Shoulder Tendinopathy: A Randomized Controlled Pilot Study
Immersive virtual reality (VR) has emerged as a promising tool to support therapeutic exercise by increasing patient motivation, promoting movement through gamification, and potentially reducing pain perception during movement. However, evidence regarding its use in shoulder tendinopathy remains limited.
This randomized controlled pilot study will evaluate the clinical efficacy and feasibility of an immersive VR-based exercise program compared with conventional physiotherapy in patients with shoulder tendinopathy. A total of 20 patients referred to the Rehabilitation Department of Hospital Universitario de La Línea de la Concepción will be randomly allocated to either a conventional therapeutic exercise group or an immersive VR-based exercise group. Both interventions will last 4 weeks, with 3 sessions per week, for a total of 12 sessions.
The primary outcome will be shoulder pain and disability measured with the Shoulder Pain and Disability Index (SPADI). Secondary outcomes will include pain intensity, upper limb function, shoulder range of motion, isometric strength, kinesiophobia, and patient satisfaction. Outcomes will be assessed at baseline and immediately after the 4-week intervention
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Shoulder pain is one of the most common musculoskeletal conditions and is frequently associated with pain, functional limitation, reduced quality of life, and increased healthcare use. Conservative management based on therapeutic exercise is considered a first-line intervention for shoulder tendinopathy. Nevertheless, adherence to conventional exercise programs may be limited by monotony, pain during movement, and fear of movement.
Immersive virtual reality may offer an additional therapeutic strategy by combining supervised exercise with gamified environments that require shoulder movements such as flexion, abduction, and rotation. In this study, VR will be used as a motivational and distractive support tool and not as a replacement for therapeutic exercise principles. The VR intervention will be delivered using standalone immersive VR headsets under direct supervision by the principal investigator.
This is a single-center, prospective, randomized, controlled pilot study with two parallel groups. Participants will be patients aged 18 to 80 years with a confirmed diagnosis of shoulder tendinopathy who are referred to the Rehabilitation Department of Hospital Universitario de La Línea de la Concepción. Participants will be randomized to either the control group, receiving conventional therapeutic exercise, or the experimental group, receiving a VR-based gamified exercise program.
Both groups will complete 12 supervised sessions over 4 weeks. The control group will perform 15 minutes of stretching followed by 30 minutes of strengthening and motor control exercises using sticks, elastic bands, and free weights. The experimental group will perform the same 15-minute stretching warm-up followed by 30 minutes of immersive VR-based gamified exercises designed to elicit therapeutic shoulder movements.
Assessments will be performed at baseline before randomization and after completion of the intervention. The primary outcome will be change in the Shoulder Pain and Disability Index. Secondary outcomes will include pain intensity measured with a numerical rating scale, upper limb function measured with the QuickDASH, shoulder range of motion measured by goniometry, isometric shoulder strength measured by dynamometry, kinesiophobia measured with the TSK-11, and treatment satisfaction measured with the CSQ-8. As this is a pilot study, the sample size has been pragmatically set at 20 participants to explore feasibility, acceptability, and preliminary effect estimates rather than to provide definitive evidence of efficacy.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Olalla Saiz Vazquez, phd
- Telefonnummer: +34625685700
- E-mail: osaiz@ubu.es
Studiesteder
-
-
-
Burgos, Spanien, 09001
- University of Burgos
-
Kontakt:
- Olalla Saiz Vazquez
- Telefonnummer: 625685700
- E-mail: osaiz@ubu.es
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Confirmed diagnosis of shoulder tendinopathy.
- Referral to the shoulder rehabilitation program.
- Age between 18 and 80 years.
- Willingness to use immersive virtual reality headsets.
- Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Acute or exacerbated phase of shoulder tendinopathy, defined as resting pain greater than 7 points on a 0-to-10 Numeric Rating Scale.
- Simultaneous participation in another clinical study.
- Current physiotherapy treatment for the same shoulder condition.
- Recent infiltrative treatment within the previous 3 months.
- Any condition contraindicating the use of immersive virtual reality, including photosensitive epilepsy, severe vertigo, claustrophobia, or active ocular or facial infections.
- Intolerance to the use of virtual reality headsets.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Conventional Therapeutic Exercise
Participants allocated to the control group will receive a conventional therapeutic exercise program for shoulder tendinopathy.
The intervention will consist of 12 supervised sessions over 4 weeks, with 3 sessions per week.
Each session will include 15 minutes of stretching followed by 30 minutes of strengthening and motor control exercises using sticks, elastic bands, and free weights.
|
A supervised physiotherapy program consisting of stretching, strengthening, and motor control exercises for the shoulder, delivered over 12 sessions during 4 weeks.
|
|
Eksperimentel: Immersive Virtual Reality-Based Physiotherapy
Participants allocated to the experimental group will receive an immersive virtual reality-based therapeutic exercise program for shoulder tendinopathy.
The intervention will consist of 12 supervised sessions over 4 weeks, with 3 sessions per week.
Each session will include 15 minutes of stretching followed by 30 minutes of gamified shoulder exercises using immersive virtual reality headsets.
The virtual reality exercises will require shoulder flexion, abduction, and rotational movements and will be supervised by the principal investigator.
|
A supervised therapeutic exercise program supported by immersive virtual reality.
Standalone virtual reality headsets will be used to deliver gamified exercises requiring shoulder movements, including flexion, abduction, and rotation.
Virtual reality will be used as a motivational and distractive support tool, not as a replacement for therapeutic exercise principles.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Shoulder Pain and Disability Index (SPADI) score
Tidsramme: Baseline and immediately after the 4-week intervention
|
The Shoulder Pain and Disability Index (SPADI) will be used to assess shoulder pain and disability.
The SPADI includes pain and disability domains, with scores ranging from 0 to 100.
Higher scores indicate greater pain and disability.
The primary endpoint will be the change in total SPADI score from baseline to post-intervention.
|
Baseline and immediately after the 4-week intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in pain intensity measured with the Numeric Rating Scale
Tidsramme: Baseline and immediately after the 4-week intervention
|
Pain intensity will be assessed using an 11-point Numeric Rating Scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
|
Baseline and immediately after the 4-week intervention
|
|
Change in upper limb function measured with the QuickDASH score
Tidsramme: Baseline and immediately after the 4-week intervention
|
Upper limb function will be assessed using the 11-item QuickDASH questionnaire.
Scores range from 0 to 100, with higher scores indicating greater disability.
|
Baseline and immediately after the 4-week intervention
|
|
Change in shoulder range of motion
Tidsramme: Baseline and immediately after the 4-week intervention
|
Shoulder range of motion will be measured using a universal manual goniometer for flexion, abduction, external rotation, and internal rotation.
Values will be recorded in degrees.
|
Baseline and immediately after the 4-week intervention
|
|
Change in isometric shoulder strength
Tidsramme: Baseline and immediately after the 4-week intervention
|
Isometric shoulder strength will be assessed using digital dynamometry for flexion, abduction, internal rotation, and external rotation.
Values will be recorded in kilograms
|
Baseline and immediately after the 4-week intervention
|
|
Change in kinesiophobia measured with the Tampa Scale for Kinesiophobia-11
Tidsramme: Baseline and immediately after the 4-week intervention
|
Kinesiophobia will be assessed using the 11-item Tampa Scale for Kinesiophobia.
Each item is scored from 1 to 4, with higher scores indicating greater fear of movement.
|
Baseline and immediately after the 4-week intervention
|
|
Patient satisfaction measured with the Client Satisfaction Questionnaire-8
Tidsramme: Immediately after the 4-week intervention
|
Treatment satisfaction will be assessed using the 8-item Client Satisfaction Questionnaire.
Higher scores indicate greater satisfaction with the received intervention.
|
Immediately after the 4-week intervention
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
- Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.
- Roach KE, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a shoulder pain and disability index. Arthritis Care Res. 1991 Dec;4(4):143-9.
- Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. Studies with pain rating scales. Ann Rheum Dis. 1978 Aug;37(4):378-81. doi: 10.1136/ard.37.4.378.
- Woby SR, Roach NK, Urmston M, Watson PJ. Psychometric properties of the TSK-11: a shortened version of the Tampa Scale for Kinesiophobia. Pain. 2005 Sep;117(1-2):137-44. doi: 10.1016/j.pain.2005.05.029.
- Kalikanov S, Baizhanova A, Tungushpayev M, Viderman D. Virtual reality for the management of musculoskeletal pain: an umbrella review. Front Med (Lausanne). 2025 Jul 9;12:1572464. doi: 10.3389/fmed.2025.1572464. eCollection 2025.
- Selles WL, Santos EC, Romero BD, Lunardi AC. Effectiveness of gamified exercise programs on the level of physical activity in adults with chronic diseases: a systematic review. Disabil Rehabil. 2024 Dec;46(26):6231-6239. doi: 10.1080/09638288.2024.2323614. Epub 2024 Mar 5.
- Vila-Dieguez O, Heindel MD, Awokuse D, Kulig K, Michener LA. Exercise for rotator cuff tendinopathy: Proposed mechanisms of recovery. Shoulder Elbow. 2023 Jun;15(3):233-249. doi: 10.1177/17585732231172166. Epub 2023 May 4.
- Desmeules F, Roy JS, Lafrance S, Charron M, Dube MO, Dupuis F, Beneciuk JM, Grimes J, Kim HM, Lamontagne M, McCreesh K, Shanley E, Vukobrat T, Michener LA. Rotator Cuff Tendinopathy Diagnosis, Nonsurgical Medical Care, and Rehabilitation: A Clinical Practice Guideline. J Orthop Sports Phys Ther. 2025 Apr;55(4):235-274. doi: 10.2519/jospt.2025.13182.
- Lucas J, van Doorn P, Hegedus E, Lewis J, van der Windt D. A systematic review of the global prevalence and incidence of shoulder pain. BMC Musculoskelet Disord. 2022 Dec 8;23(1):1073. doi: 10.1186/s12891-022-05973-8.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RHB-HOMVR-2026
- SICEIA-2026-000558 (Anden identifikator: Comité de Ética de la Investigación Provincial de Cádiz / SICEIA, Junta de Andalucía)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Conventional Therapeutic Exercise
-
Centre Hospitalier Universitaire de Saint EtienneRekrutteringNyrekræft (nyrecelle). | Blærekræft (urothelial, overgangscelle).Frankrig
-
Boston Medical CenterSuspenderetStofbrugsforstyrrelser | Psykisk sundhedsproblemForenede Stater
-
Oui Therapeutics, Inc.National Institute of Mental Health (NIMH); Florida State UniversityIkke rekrutterer endnuPTSD | Post traumatisk stress syndrom
-
Universidade Federal de Sao CarlosAfsluttet
-
Kaohsiung Veterans General Hospital.Afsluttet
-
National Development and Research Institutes, Inc.National Institute on Drug Abuse (NIDA)AfsluttetStof-relaterede lidelser | Psykiske lidelserForenede Stater
-
Click Therapeutics, Inc.AfsluttetMigræne | Hovedpine | Hovedpine, migræne | Episodisk migræneForenede Stater
-
DynamiCare HealthNational Institute on Drug Abuse (NIDA)RekrutteringStimulerende brugsforstyrrelseForenede Stater
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinRekrutteringPost traumatisk stress syndromFrankrig
-
Universitätsklinikum Hamburg-EppendorfGerman Research FoundationAfsluttet