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CompletedNCT05961033Updated Sep 3, 2025

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

An observational study in Pain, Quality of Life and Range of Motion, sponsored by Kocaeli University. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-03.

Sponsored by Kocaeli University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
36
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

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

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03

In context

Pain

2,219 studies on the registry are indexed under Pain; 917 are open to participants now.

This study's enrollment of 36 is below the median of 107 across 270 observational studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Kocaeli University is the lead sponsor of 210 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Inability to cooperate VR
  • Surgery on the upper extremity or trunk
  • Neurological disease
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
36 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceVirtual Reality based exercises

    Play VR games

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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).

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

Secondary outcomes

  1. Shoulder mobility angles change

    Shouder mobility will be assessed by goniometric measurement

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

07

Study locations

2 sites
  • Kocaeli University Faculty of Medicine Hospital
    Kocaeli, Turkey (Türkiye)
  • Sakarya University Physiotherapy and Rehabilitation Research Center
    Sakarya, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05961033
Lead sponsor
Kocaeli University
Collaborators
Sakarya Applied Sciences University
Responsible party
Oguzhan Bahadir DEMIR (Principal Investigator, Kocaeli University) — Principal investigator
First posted
Jul 27, 2023
Start date
Sep 1, 2023
Primary completion
Nov 1, 2023
Completion
Dec 25, 2023
Last update
Sep 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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