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

NCT06482255 | Not Yet Recruiting

• 1 other identifier: CEIM/2024/3/063
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rotator Cuff Injuries

Keywords

rotator cuff; virtual reality; manual therapy; therapeutic exercise

Outcome Measures

Primary Outcomes (3)

• Perceived pain and disability regarding the shoulder

  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

  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

  continuous metric quantitative variable. The investigators will use an inclinometer to assess flexion, extension, rotation, abduction and adduction.

  10 weeks

Study Arms (2)

virtual reality and manual therapy and therapeutic exercise

EXPERIMENTAL

* Soft tissue massage * Mobilization of the glenohumeral joint * Scapular retraining Therapeutic Exercise

Other: manual therapy and therapeutic exercise and virtual reality

manual therapy and therapeutic exercise

ACTIVE COMPARATOR

* Soft tissue massage * Mobilization of the glenohumeral joint * Scapular retraining

Other: manual therapy and therapeutic exercise

Interventions

manual therapy and therapeutic exercise OTHER

* Soft tissue massage * Mobilization of the glenohumeral joint * Scapular retraining Therapeutic Exercise

manual therapy and therapeutic exercise

manual therapy and therapeutic exercise and virtual reality OTHER

* Soft tissue massage * Mobilization of the glenohumeral joint * Scapular retraining Therapeutic Exercise * virtual reality

virtual reality and manual therapy and therapeutic exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• previous shoulder surgeries, medical pathologies such as cancer
• rheumatoid disease, infections and/or fractures, and CNS involvement.

Sponsors & Collaborators

• University of Alcala: lead

Related Publications (22)

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MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Musculoskeletal Manipulations; Exercise Therapy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Central Study Contacts

Alejandro Nubla Romero

CONTACT

+34 637247797; alejandronublaromero@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share