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Shoulder TendinopathyHOMVRNCT07592156

Immersive Virtual Reality Versus Conventional Physiotherapy for Shoulder Tendinopathy

A study testing Conventional Therapeutic Exercise and Immersive Virtual Reality-Based Therapeutic Exercise in people with Shoulder Tendinopathy, run by Universidad de Burgos at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Shoulder Tendinopathy
What is being tested?
Conventional Therapeutic Exercise and Immersive Virtual Reality-Based Therapeutic Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
1 May 2026to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Olalla Saiz Vazquez, phd contact

+34625685700

osaiz@ubu.es

Spain1 site
  • University of Burgos

    Burgos, 09001

    Olalla Saiz Vazquez, 625685700, osaiz@ubu.es

Other trials in Spain

About this study

Official title: 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

Read the detailed description

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.

Being tested
Conventional Therapeutic Exercise, Immersive Virtual Reality-Based Therapeutic Exercise
Keywords
rotator cuff tendinopathy, shoulder pain
Medical subject headings
Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional Therapeutic ExerciseOther

    A supervised physiotherapy program consisting of stretching, strengthening, and motor control exercises for the shoulder, delivered over 12 sessions during 4 weeks.

  • Immersive Virtual Reality-Based Therapeutic ExerciseOther

    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.

Study groups in NCT07592156
Study groupRoleWhat they receive
Conventional Therapeutic ExerciseActive comparatorParticipants 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.
Receives: Other: Conventional Therapeutic Exercise
Immersive Virtual Reality-Based PhysiotherapyExperimentalParticipants 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.
Receives: Other: Immersive Virtual Reality-Based Therapeutic Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Shoulder Pain and Disability Index (SPADI) score

    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.

    Measured: Baseline and immediately after the 4-week intervention

Secondary outcomes (6)
  1. Change in pain intensity measured with the Numeric Rating Scale

    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.

    Measured: Baseline and immediately after the 4-week intervention

  2. Change in upper limb function measured with the QuickDASH score

    Upper limb function will be assessed using the 11-item QuickDASH questionnaire. Scores range from 0 to 100, with higher scores indicating greater disability.

    Measured: Baseline and immediately after the 4-week intervention

  3. Change in shoulder range of motion

    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.

    Measured: Baseline and immediately after the 4-week intervention

  4. Change in isometric shoulder strength

    Isometric shoulder strength will be assessed using digital dynamometry for flexion, abduction, internal rotation, and external rotation. Values will be recorded in kilograms

    Measured: Baseline and immediately after the 4-week intervention

  5. Change in kinesiophobia measured with the Tampa Scale for Kinesiophobia-11

    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.

    Measured: Baseline and immediately after the 4-week intervention

  6. Patient satisfaction measured with the Client Satisfaction Questionnaire-8

    Treatment satisfaction will be assessed using the 8-item Client Satisfaction Questionnaire. Higher scores indicate greater satisfaction with the received intervention.

    Measured: Immediately after the 4-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, open-label, single-center, controlled pilot study with two parallel groups. Participants with shoulder tendinopathy will be assigned to either conventional physiotherapy or an immersive virtual reality-based therapeutic exercise program. Both groups will receive 12 supervised sessions over 4 weeks.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07592156
Sponsor's protocol ID
RHB-HOMVR-2026
Other IDs
SICEIA-2026-000558
Acronym
HOMVR
Status last verified
May 2026
First submitted
11 May 2026
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared. Data will be pseudonymized and stored securely in accordance with applicable European and Spanish data protection regulations. Aggregated study results may be disseminated through scientific reports or publications.

Publications

  • 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.

    PubMed 686873
  • 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.

    PubMed 10245370
  • 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.

    PubMed 16055269
  • 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.

    PubMed 15866967
  • 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.

    PubMed 11188601
  • 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.

    PubMed 40703264
  • 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.

    PubMed 38444153
  • 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.

    PubMed 37325389
  • 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.

    PubMed 40165544
  • 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.

    PubMed 36476476

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Therapeutic Exercise and Immersive Virtual Reality-Based Therapeutic Exercise in people with Shoulder Tendinopathy, run by Universidad de Burgos at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olalla Saiz Vazquez, phd (+34625685700, osaiz@ubu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Shoulder Pain and Disability Index (SPADI) score (time frame: Baseline and immediately after the 4-week intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07592156, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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