Clinical trial NCT06056440: Efficacy of a Physical Rehabilitation Program Using Virtual Reality in Patients With Chronic Tendinopathy (Virtendon-Rehab)
Official title: Efficacy of a Physical Rehabilitation Program Using Virtual Reality in Patients With Chronic Tendinopathy (Virtendon-Rehab)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tendinopathy
Patellar Tendinopathy
Tendinopathy, Elbow
Tendinopathy Rotator Cuff
Achilles Tendinopathy
Keywords: virtual reality
chronic tendinopathy
physical therapy
Lead sponsor: University of Cadiz
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Disability (Shoulder And Pain Disability Index)
timeFrame: Fom Baseline up to 24 Weeks Follow-up
measure: Disability (Victorian Institute of Sport Assessment - Patellar)
timeFrame: Fom Baseline up to 24 Weeks Follow-up
measure: Disability (Victorian Institute of Sport Assessment - Achilles)
timeFrame: Fom Baseline up to 24 Weeks Follow-up
measure: Pain (Visual Analogue Scale)
timeFrame: Fom Baseline up to 24 Weeks Follow-up
Secondary outcomes:
measure: Range of motion (Goniometer)
timeFrame: Fom Baseline up to 24 Weeks Follow-up
measure: Strength (Dynamometer)
timeFrame: Fom Baseline up to 24 Weeks Follow-up
measure: Kinesiophobia (Tampa Scale Questionnaire)
timeFrame: From Baseline up to 24 Weeks Follow-up
measure: Quality of Life (36-item Short Form Survey)
timeFrame: From Baseline up to 24 Weeks Follow-up
measure: Adherence (Exercise Adherence Rating Scale)
timeFrame: 12 Weeks and 24 Weeks
measure: User satisfaction (Consumer Report Effectiveness Scale)
timeFrame: 12 Weeks and 24 Weeks
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Faculty of Nursing and Physiotherapy
Study officials:
References:
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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.