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Completed

NCT Number: NCT05961033

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Quality of Life Range of Motion Signs and Symptoms Virtual Reality

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli University Faculty of Medicine Hospital, Kocaeli, Turkey (Türkiye)

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About this study

Individuals in the first group to be included in the study group will be included in a VR-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 use the Oculus Quest 2 VR system in the virtual environment thanks to the three-dimensional glasses and handpiece that can be worn on the head. They will play the registered games. These games will include purpose-oriented activities such as lying on the head and using bilaterally, which are intended to use the upper extremities of individuals with AC in daily life. Participants will be treated under the constant supervision of a physiotherapist, will be rested at the end of the exercise, and will leave the clinic after making sure that there is no problem.

Individuals in the second group, who will be included in the traditional exercise group, will be included in the stretching and strengthening exercise program for half an hour a day, 5 days a week for a total of 4 weeks, for a total of 10 hours, in addition to the routine electrotherapy programs for half an hour a day, 5 days a week for a total of 4 weeks. The exercises will be performed by a physiotherapist working in the clinic and blind to the study.

Pain levels (Visual Analogue Scale), upper extremity range of motion (Goniometric measurement), functional activity levels (Shoulder Pain and Disability Index) and quality of life (SF-36) of all participants will be evaluated before and after the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Virtual Reality based exercises

Device

Play VR games

Primary outcomes

  1. Pain severity change

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

    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.

  2. Quality of Life level change

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

    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.

  3. Shoulder functionality level change

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

    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).

Secondary outcomes

  1. Shoulder mobility angles change

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

    Shouder mobility will be assessed by goniometric measurement

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Collaborators

  • Sakarya Applied Sciences University

Registry information

Official study title

The Effects of Virtual Reality Based Exercises on Pain, Range of Motion and Quality of Life in Patients With Adhesive Capsulitis

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2023
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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