The Effects of Virtual Reality Based Exercises in Patients With Adhesive Capsulitis

NCT05961033 | Completed

• 1 other identifier: 32/22
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

Musculoskeletal disorders such as adhesive capsulitis (AC) affect tissues such as muscles, bones, joints, tendons and ligaments and are the second most disabling condition worldwide. Musculoskeletal Systemic disorders are typically characterized by pain, limitations in joint range of motion or functional ability. Existing studies have shown that Virtual Reality (VR) is beneficial in pain management for example; pain relief during dressing changes in burn patients. VR can also reduce anxiety, distract from the fear of pain, and reduce stress. It can distract the patients who are afraid of moving due to pain and enable them to move freely. In this study, AC patients will be treated with VR application. Patients pain levels, upper extremity range of motion, functional activity levels and quality of life levels will be evaluated. A total of 36 patients will be included in the study. This observational randomized controlled study will contribute to the literature by investigating the effects of VR based exercises in individuals with AC.

Conditions

Pain; Quality of Life; Range of Motion; Virtual Reality

Outcome Measures

Primary Outcomes (3)

• Pain severity change

  pain intensity after VR based exercises will be assessed by Visual Analogue Scale (VAS). VAS is often used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain (0-10). Ten shows more pain intensity.

  Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises

• Quality of Life level change

  Level of Quality of Life will be assessed by Short Form- 36 (SF-36). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used. High points show high quality ol life levels.

  Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises

• Shoulder functionality level change

  Shoulder functionality will be assessed by Shoulder and Pain Disability Inventory (SPADI). The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder. The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).

  Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises

Secondary Outcomes (1)

• Shoulder mobility angles change

  Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises

Study Arms (2)

study

Individuals in the first group to be included in the study group will be included in a virtual reality-based exercise program for half an hour a day, 5 days a week for a total of 4 weeks, in addition to routine electrotherapy programs for half an hour a day, 5 days a week for a total of 4 weeks. These individuals will be able to play the games saved in the Oculus Quest 2 SG system in the virtual environment, thanks to the three-dimensional glasses and handpiece that can be worn on the head.

Device: Virtual Reality based exercises

control

Individuals who receive traditional electrotherapy and exercise program

Interventions

Virtual Reality based exercises DEVICE

Play VR games

study

Eligibility Criteria

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

Study Population

Diagnosed as having Adhesive Capsulitis and being treated in the rehabilitation center

You may qualify if:

• Being between the ages of 18-65
• Clinical diagnosis of adhesive capsulitis

You may not qualify if:

• Inability to cooperate VR
• Surgery on the upper extremity or trunk
• Neurological disease

Sponsors & Collaborators

• Kocaeli University: lead
• Sakarya University of Applied Sciences: collaborator

Study Sites (2)

Kocaeli University Faculty of Medicine Hospital

Kocaeli, Turkey (Türkiye)

Location

Sakarya University Physiotherapy and Rehabilitation Research Center

Sakarya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 27, 2023
• Study Start: September 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 25, 2023
• Last Updated: September 3, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)