Achilles Tendinopathy, Patellar Tendinopathy, Tendinopathy, Tendinopathy, Elbow, Tendinopathy Rotator Cuff
Conditions
Keywords
virtual reality, chronic tendinopathy, physical therapy
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.
Interventions
PROCEDUREVirtual 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
OTHERControl group
The control group will only receive their usual treatment program for the 12-week duration of the study.
Sponsors
University of Cadiz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
A single-blind method will be carried out on the persons collecting and analysing the data
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability (Shoulder And Pain Disability Index) | Fom Baseline up to 24 Weeks Follow-up | Longitudinal change from 0 to 100. Higher scores mean worse outcome. |
| Disability (Victorian Institute of Sport Assessment - Patellar) | Fom Baseline up to 24 Weeks Follow-up | Longitudinal change from 0 to 100. Higher scores mean better outcome. |
| Disability (Victorian Institute of Sport Assessment - Achilles) | Fom Baseline up to 24 Weeks Follow-up | Longitudinal change from 0 to 100. Higher scores mean better outcome. |
| Pain (Visual Analogue Scale) | Fom Baseline up to 24 Weeks Follow-up | Longitudinal change from 0 to 10. Higher scores mean worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence (Exercise Adherence Rating Scale) | 12 Weeks and 24 Weeks | 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. |
| Range of motion (Goniometer) | Fom Baseline up to 24 Weeks Follow-up | Longitudinal change |
| User satisfaction (Consumer Report Effectiveness Scale) | 12 Weeks and 24 Weeks | Global satisfaction with the treatment received. 3-item scale scoring from 0 to 300. Higher scores mean better outcome. |
| Strength (Dynamometer) | Fom Baseline up to 24 Weeks Follow-up | Longitudinal change |
| Kinesiophobia (Tampa Scale Questionnaire) | From Baseline up to 24 Weeks Follow-up | 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 |
| Quality of Life (36-item Short Form Survey) | From Baseline up to 24 Weeks Follow-up | Longitudinal change from 0 to 100. Higher scores mean better outcome. |
Countries
Spain
Contacts
Primary ContactDavid Lucena Anton, PhD
Outcome results
None listed