NCT06056440

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 28, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

May 10, 2024

Status Verified

September 1, 2023

Enrollment Period

11 months

First QC Date

September 11, 2023

Last Update Submit

May 9, 2024

Conditions

TendinopathyPatellar TendinopathyTendinopathy, ElbowTendinopathy Rotator CuffAchilles Tendinopathy

Keywords

virtual realitychronic tendinopathyphysical therapy

Outcome Measures

Primary Outcomes (4)

  • Disability (Shoulder And Pain Disability Index)

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

    Fom Baseline up to 24 Weeks Follow-up

  • Disability (Victorian Institute of Sport Assessment - Patellar)

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

    Fom Baseline up to 24 Weeks Follow-up

  • Disability (Victorian Institute of Sport Assessment - Achilles)

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

    Fom Baseline up to 24 Weeks Follow-up

  • Pain (Visual Analogue Scale)

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

    Fom Baseline up to 24 Weeks Follow-up

Secondary Outcomes (6)

  • Range of motion (Goniometer)

    Fom Baseline up to 24 Weeks Follow-up

  • Strength (Dynamometer)

    Fom Baseline up to 24 Weeks Follow-up

  • Kinesiophobia (Tampa Scale Questionnaire)

    From Baseline up to 24 Weeks Follow-up

  • Quality of Life (36-item Short Form Survey)

    From Baseline up to 24 Weeks Follow-up

  • Adherence (Exercise Adherence Rating Scale)

    12 Weeks and 24 Weeks

  • +1 more secondary outcomes

Study Arms (2)

VR group

EXPERIMENTAL

The 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.

Procedure: Virtual reality

Control group

OTHER
Other: Control group

Interventions

Virtual realityPROCEDURE

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

VR group
Control groupOTHER

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing and Physiotherapy

Cadiz, 11009, Spain

RECRUITING

Related Publications (7)

  • 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.

    PMID: 24149868BACKGROUND

  • 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.

    PMID: 27852585BACKGROUND

  • 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.

    PMID: 27810828BACKGROUND

  • 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.

    PMID: 32027185BACKGROUND

  • 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.

    PMID: 8156067BACKGROUND

  • 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.

    PMID: 18812414BACKGROUND

  • 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.

    PMID: 39974760DERIVED

Related Links

MeSH Terms

Conditions

TendinopathyElbow Tendinopathy

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and InjuriesElbow InjuriesArm Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

David Lucena Anton, PhD

CONTACT

956015699david.lucena@uca.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A single-blind method will be carried out on the persons collecting and analysing the data
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 28, 2023

Study Start

November 28, 2023

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

May 10, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)