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TendinopathyVirtendonRehabNCT06056440

Efficacy of a Physical Rehabilitation Program Using Virtual Reality in Patients With Chronic Tendinopathy (Virtendon-Rehab)

A study testing Virtual reality in people with Tendinopathy and Patellar Tendinopathy, run by University of Cadiz at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Chronic tendinopathies (CT) have a high prevalence (30% of musculoskeletal injuries), causing pain, decreased physical activity and functionality, as well as limitations in daily life. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Virtual reality
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSpain
Study dates
28 Nov 2023to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of tendinopathy (shoulder rotator cuff tendinopathy, epicondylitis/epicondylitis, patellar tendinopathy, achilles tendinopathy).
  • Duration of symptoms: greater than 6 weeks.

Who cannot join

  • People who have any pathology that prevents them from performing physical exercise.
  • Persons who have undergone surgery.
  • Persons who have an illness that may be a contraindication to the proposed procedure.
  • Persons who have received exercise therapy in the last 3 months.
  • Persons who have received corticosteroid injections in the last 3 months.

Trial locations and contacts

1 site in 1 country.

David Lucena Anton, PhD contact

956015699 ext. +34

david.lucena@uca.es

Spain1 site, 1 recruiting

  • Faculty of Nursing and Physiotherapy

    Cadiz, 11009

    David Lucena-Anton, PhD, 956015699 ext. +34, david.lucena@uca.es

    Recruiting

Other trials in Spain

About this study

Chronic tendinopathies (CT) have a high prevalence (30% of musculoskeletal injuries), causing pain, decreased physical activity and functionality, as well as limitations in daily life. Virtual reality (VR) fosters patient recovery through playful activities that promote competitiveness, stimulates motivation and continuous attention, allows individualizing the exercise program, objectively assessing the execution of the treatment and monitoring the patient's evolution. Therefore, the VIRTENDON-REHAB project aims to conduct a low-risk randomized controlled clinical trial to analyze the efficacy of a VR-based physical rehabilitation program in a population diagnosed with CT on pain, functionality, range of motion, strength, muscle activation pattern, kinesiophobia, quality of life, adherence to treatment and patient satisfaction with the use of the system, compared to a control group. Likewise, the aim is to characterize the clinical profile of this population and to know the relationships between the previous variables. Measurements will be taken at the beginning of the intervention, at the end (12 weeks) and 3 months after the end of the intervention. A descriptive analysis will be performed, inter- and intra-group differences will be analyzed by means of t-Student, Wilcoxon, Mann-Whitney U and mixed ANOVA tests. Cohen's d will be used to determine the effect size. Relationships between variables will be analyzed using structural equations. The results obtained will allow improving knowledge on the management of CT using VR, as well as improving clinical care and reducing healthcare costs.

Being tested
Virtual reality, Control group
Keywords
virtual reality, chronic tendinopathy, physical therapy
Medical subject headings
Tendinopathy, Elbow Tendinopathy

What participants receive

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

  • Virtual realityProcedure or surgery

    The VR intervention program for the experimental group will be carried out with a frequency of 3 sessions/week, duration of approximately 45 minutes, and for a total of 12 weeks, being performed in addition to the patient's usual treatment program.

    The Oculus Quest 2 device (which consists of VR glasses and different accessories) will be used, in conjunction with software specifically designed for physical rehabilitation of upper and lower limbs: Dynamics VR. Specifically, the specific functional rehabilitation program will be used, which comprises exercises that are easy to perform, with a playful component, and which encourage the patient's continuous attention to the task performed, acting as a distractor phenomenon in the face of restrictive movement factors such as fear of pain or movement. This software offers the possibility of adjusting the number of repetitions and characteristics of the exercises, thus allowing an individualized physical rehabilitation

  • Control groupOther

    The control group will only receive their usual treatment program for the 12-week duration of the study.

Study groups in NCT06056440
Study groupRoleWhat they receive
VR groupExperimentalThe VR intervention program for the experimental group will be carried through the Oculus Quest 2 device (which consists of VR glasses and different accessories) will be used, in conjunction with software specifically designed for physical rehabilitation of upper and lower limbs: Dynamics VR. This VR intervention will be performed in addition to the patient's usual treatment program.
Receives: Procedure: Virtual reality
Control groupOtherNot described
Receives: Other: Control group

What is being measured

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

  1. Disability (Shoulder And Pain Disability Index)

    Longitudinal change from 0 to 100. Higher scores mean worse outcome.

    Measured: Fom Baseline up to 24 Weeks Follow-up

  2. Disability (Victorian Institute of Sport Assessment - Patellar)

    Longitudinal change from 0 to 100. Higher scores mean better outcome.

    Measured: Fom Baseline up to 24 Weeks Follow-up

  3. Disability (Victorian Institute of Sport Assessment - Achilles)

    Longitudinal change from 0 to 100. Higher scores mean better outcome.

    Measured: Fom Baseline up to 24 Weeks Follow-up

  4. Pain (Visual Analogue Scale)

    Longitudinal change from 0 to 10. Higher scores mean worse outcome.

    Measured: Fom Baseline up to 24 Weeks Follow-up

Secondary outcomes (6)

  1. Range of motion (Goniometer)

    Longitudinal change

    Measured: Fom Baseline up to 24 Weeks Follow-up

  2. Strength (Dynamometer)

    Longitudinal change

    Measured: Fom Baseline up to 24 Weeks Follow-up

  3. Kinesiophobia (Tampa Scale Questionnaire)

    Longitudinal change from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia

    Measured: From Baseline up to 24 Weeks Follow-up

  4. Quality of Life (36-item Short Form Survey)

    Longitudinal change from 0 to 100. Higher scores mean better outcome.

    Measured: From Baseline up to 24 Weeks Follow-up

  5. Adherence (Exercise Adherence Rating Scale)

    The original English version of the EARS is a 16-item, self-reported questionnaire, which assessadherence of prescribed exercises [6]. The EARS consist of 3 sections. Section 'A' is about prescribedexercise questionnaire. This section consists of 5 questions, which are related to way of doing activitiesand exercise that people often do to improve their physical quality of life. Section 'B' is about exerciseadherence behavior, so called exercise adherence rating scale. This section consists of 6 items, which isan actual measure to identify exercise adherence. This evaluates whether individuals do their exercise asper recommendation or not. Section 'C' is about reasons for adherence/non-adherence of exercises. Thissection consists of 10 items, which assesses factors that hinders and facilitates the exercises. Higher scores mean better outcome.

    Measured: 12 Weeks and 24 Weeks

  6. User satisfaction (Consumer Report Effectiveness Scale)

    Global satisfaction with the treatment received. 3-item scale scoring from 0 to 300. Higher scores mean better outcome.

    Measured: 12 Weeks and 24 Weeks

Timeline

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

  1. First posted28 Sep 2023
  2. Study start28 Nov 2023
  3. Primary completionNov 2024 (estimated)
  4. Study completionDec 2024 (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
Parallel Assignment
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06056440
Sponsor's protocol ID
University of Cadiz PR2022-049
Other IDs
PR2022-049
Acronym
VirtendonRehab
Status last verified
Sep 2023
First submitted
11 Sep 2023
Last updated
10 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kaux JF, Forthomme B, Goff CL, Crielaard JM, Croisier JL. Current opinions on tendinopathy. J Sports Sci Med. 2011 Jun 1;10(2):238-53.

    PubMed 24149868

  • Mallows A, Debenham J, Walker T, Littlewood C. Association of psychological variables and outcome in tendinopathy: a systematic review. Br J Sports Med. 2017 May;51(9):743-748. doi: 10.1136/bjsports-2016-096154. Epub 2016 Nov 16.

    PubMed 27852585

  • Chen KB, Sesto ME, Ponto K, Leonard J, Mason A, Vanderheiden G, Williams J, Radwin RG. Use of Virtual Reality Feedback for Patients with Chronic Neck Pain and Kinesiophobia. IEEE Trans Neural Syst Rehabil Eng. 2017 Aug;25(8):1240-1248. doi: 10.1109/TNSRE.2016.2621886. Epub 2016 Oct 26.

    PubMed 27810828

  • Dominguez-Tellez P, Moral-Munoz JA, Salazar A, Casado-Fernandez E, Lucena-Anton D. Game-Based Virtual Reality Interventions to Improve Upper Limb Motor Function and Quality of Life After Stroke: Systematic Review and Meta-analysis. Games Health J. 2020 Feb;9(1):1-10. doi: 10.1089/g4h.2019.0043.

    PubMed 32027185

  • Almekinders LC, Almekinders SV. Outcome in the treatment of chronic overuse sports injuries: a retrospective study. J Orthop Sports Phys Ther. 1994 Mar;19(3):157-61. doi: 10.2519/jospt.1994.19.3.157.

    PubMed 8156067

  • Cook JL, Purdam CR. Is tendon pathology a continuum? A pathology model to explain the clinical presentation of load-induced tendinopathy. Br J Sports Med. 2009 Jun;43(6):409-16. doi: 10.1136/bjsm.2008.051193. Epub 2008 Sep 23.

    PubMed 18812414

  • Lucena-Anton D, Dominguez-Romero JG, Chacon-Barba JC, Santi-Cano MJ, Luque-Moreno C, Moral-Munoz JA. Efficacy of a physical rehabilitation program using virtual reality in patients with chronic tendinopathy: A randomized controlled trial protocol (VirTendon-Rehab). Digit Health. 2025 Feb 18;11:20552076241297043. doi: 10.1177/20552076241297043. eCollection 2025 Jan-Dec.

    PubMed 39974760

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality in people with Tendinopathy and Patellar Tendinopathy, run by University of Cadiz 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 May 2024. 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?

Results are not available in the source record.

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

Contact David Lucena Anton, PhD (956015699 ext. +34, david.lucena@uca.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disability (Shoulder And Pain Disability Index) (time frame: Fom Baseline up to 24 Weeks Follow-up). The study lists 4 primary outcomes in all. 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 NCT06056440, which also lists 7 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 10 May 2024.

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