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

Tendinopathy Clinical Trial

— VirtendonRehab  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056440
• Other study ID #: University of Cadiz PR2022-049
• Secondary ID: PR2022-049
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2023
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: University of Cadiz
• Contact: David Lucena Anton, PhD
• Phone: 956015699
• Email: david.lucena[@]uca.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of tendinopathy (shoulder rotator cuff tendinopathy, epicondylitis/epicondylitis, patellar tendinopathy, achilles tendinopathy).

• Duration of symptoms: greater than 6 weeks.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Elbow Tendinopathy
• Patellar Tendinopathy
• Tendinopathy
• Tendinopathy Rotator Cuff
• Tendinopathy, Elbow

Intervention

Procedure:
• Virtual reality
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

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

Locations

Country	Name	City	State
Spain	Faculty of Nursing and Physiotherapy	Cadiz

Sponsors (1)

Lead Sponsor	Collaborator
University of Cadiz

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Pain (Visual Analogue Scale)	Longitudinal change from 0 to 10. Higher scores mean worse outcome.	Fom Baseline up to 24 Weeks Follow-up
Secondary	Range of motion (Goniometer)	Longitudinal change	Fom Baseline up to 24 Weeks Follow-up
Secondary	Strength (Dynamometer)	Longitudinal change	Fom Baseline up to 24 Weeks Follow-up
Secondary	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	From Baseline up to 24 Weeks Follow-up
Secondary	Quality of Life (36-item Short Form Survey)	Longitudinal change from 0 to 100. Higher scores mean better outcome.	From Baseline up to 24 Weeks Follow-up
Secondary	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.	12 Weeks and 24 Weeks
Secondary	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.	12 Weeks and 24 Weeks

External Links

•   Virtual reality software