"Evidence of the Use of Virtual Reality Versus Manual Therapy and Therapeutic Exercise in Rotator Cuff Injury"

June 29, 2024 updated by: Alejandro Nubla Romero, University of Alcala

Evidence of the Use of Virtual Reality Versus Manual Therapy and Therapeutic Exercise in Rotator Cuff Injury

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

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Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: virtual reality and manual therapy and therapeutic exercise
  • Soft tissue massage
  • Mobilization of the glenohumeral joint
  • Scapular retraining Therapeutic Exercise
Other: manual therapy and therapeutic exercise and virtual reality
  • Soft tissue massage
  • Mobilization of the glenohumeral joint
  • Scapular retraining Therapeutic Exercise
  • virtual reality
Active Comparator: manual therapy and therapeutic exercise
  • Soft tissue massage
  • Mobilization of the glenohumeral joint
  • Scapular retraining
Other: manual therapy and therapeutic exercise
  • Soft tissue massage
  • Mobilization of the glenohumeral joint
  • Scapular retraining Therapeutic Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived pain and disability regarding the shoulder
Time Frame: 10 weeks
continuous metric quantitative variable. To measure it the investigators will use the SPADI questionnaire that takes values from or to 10 in each question. Reliability is greater than 0.7, with ranges between 0.7 and 0.9
10 weeks
strength
Time Frame: 10 weeks
continuous metric quantitative variable and the investigators will measure it using the dynamometer. It has a reliability of 0.90%, making it a useful force measurement instrument.
10 weeks
Active shoulder mobility
Time Frame: 10 weeks
continuous metric quantitative variable. The investigators will use an inclinometer to assess flexion, extension, rotation, abduction and adduction.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alcala

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 29, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIM/2024/3/063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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