Clinical trial NCT06482255: "Evidence of the Use of Virtual Reality Versus Manual Therapy and Therapeutic Exercise in Rotator Cuff Injury"
Official title: Evidence of the Use of Virtual Reality Versus Manual Therapy and Therapeutic Exercise in Rotator Cuff Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rotator Cuff Injuries
Keywords: rotator cuff
virtual reality
manual therapy
therapeutic exercise
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness of virtual reality (VR) compared to manual therapy and therapeutic exercise in treating rotator cuff injuries. It involves 108 participants divided into two groups: one receiving VR combined with manual therapy and therapeutic exercise, and the other receiving only manual therapy and therapeutic exercise. The study spans 10 weeks, with assessments at the beginning, midpoint, and end. Variables measured include quality of life, perceived pain, shoulder disability, strength, pain intensity, and shoulder mobility. The aim is to determine if VR provides better outcomes in these variables compared to conventional treatments.

Detailed description: Introduction Background: The shoulder is one of the most mobile yet unstable joints in the human body, making it prone to injuries like tendinopathies, which are among the most disabling injuries in the upper limb. Rotator cuff injuries are particularly prevalent.

Rotator Cuff: Comprises the supraspinatus, infraspinatus, subscapularis, and teres minor muscles, which provide stability, strength, and movement to the shoulder joint.

Treatment Options: There are conventional (non-surgical) and surgical treatments for rotator cuff injuries. Conventional treatments are often preferred due to fewer complications and lower costs.

Study Objective The study aims to assess the effectiveness of VR in comparison with traditional manual therapy and therapeutic exercise for treating rotator cuff injuries. The goal is to see if integrating VR can enhance patient outcomes.

Methodology Participants: 108 individuals will be recruited and divided into two groups. Group 1: Will receive a combination of VR, manual therapy, and therapeutic exercise.

Group 2: Will receive only manual therapy and therapeutic exercise. Duration: The treatment will last for 10 weeks.

Measurements: The study will measure various outcomes, including:

Quality of Life: Assessed using the SF-36 questionnaire. Perceived Pain and Shoulder Disability: Measured with the SPADI questionnaire. Strength: Evaluated using dynamometry. Pain Intensity: Assessed with the Numerical Rating Scale (NRS). Active Shoulder Mobility: Measured using an inclinometer. Assessment Points: Measurements will be taken before treatment, at the midpoint (5 weeks), and at the end of the treatment (10 weeks).

Data Collection and Analysis Data on pain, disability, strength, and range of motion will be collected at three intervals: pre-treatment, 5 weeks, and 10 weeks.

Quality of life will be assessed at the beginning and end of the treatment. Statistical Analysis: Using SPSS version 29.0, descriptive and inferential statistics will be conducted to analyze the data. An ANOVA will be used to study the treatment effects, considering group and time as factors.

Limitations Population Characteristics: The specific demographic characteristics of the study population might limit the generalizability of the results.

Lack of 3D Kinetic Evaluation: The absence of a three-dimensional kinetic evaluation protocol for scapular dyskinesia is noted as a limitation.

Cost of VR Technology: The expense associated with VR technology is highlighted as a limitation since it is still a growing and costly field.

Conclusion The study seeks to provide evidence on whether VR can be an effective tool alongside traditional therapies for rotator cuff injuries, potentially offering new avenues for rehabilitation practices.

.

Eligibility criteria: Inclusion Criteria:

* be between 18 and 65 years old
* have a rotator cuff injury lasting less than 3 months
* have a limitation in strength of less than 30%
* pain in mobility greater than 4/10

Exclusion Criteria:

* previous shoulder surgeries, medical pathologies such as cancer
* rheumatoid disease, infections and/or fractures, and CNS involvement.
* In addition, physiotherapy treatment different from that of the study and not having an understanding of the Spanish language will be cause for exclusion.

Primary outcomes:
measure: Perceived pain and disability regarding the shoulder
timeFrame: 10 weeks
measure: strength
timeFrame: 10 weeks
measure: Active shoulder mobility
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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