PainNCT05961033
The Effects of Virtual Reality Based Exercises in Patients With Adhesive Capsulitis
An observational study of Pain and Quality of Life, run by Kocaeli University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Quality of Life, Range of Motion
- What is being tested?
- Virtual Reality based exercises
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 25 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed as having Adhesive Capsulitis and being treated in the rehabilitation center
Who may be able to join
- Being between the ages of 18-65
- Clinical diagnosis of adhesive capsulitis
Who cannot join
- Inability to cooperate VR
- Surgery on the upper extremity or trunk
- Neurological disease
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kocaeli University Faculty of Medicine Hospital
Kocaeli
Sakarya University Physiotherapy and Rehabilitation Research Center
Sakarya
About this study
Official title: The Effects of Virtual Reality Based Exercises on Pain, Range of Motion and Quality of Life 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.
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.
- Conditions
- Pain, Quality of Life, Range of Motion, Virtual Reality
- Being tested
- Virtual Reality based exercises
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality based exercisesDevice
Play VR games
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual Reality based exercises | |
| control | Individuals who receive traditional electrotherapy and exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Sep 2023
- Primary completion1 Nov 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Collaborators
- Sakarya Applied Sciences University
- Responsible party
- Principal investigator, Oguzhan Bahadir DEMIR, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961033
- Sponsor's protocol ID
- 32/22
- Status last verified
- Aug 2023
- First submitted
- 26 Jun 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Virtual Reality Based Exercises on Pain, Range of Motion and Quality of Life in Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT05961033
- Acronym / sponsor ID
- 32/22
- Conditions
- Pain, Quality of Life, Range of Motion, Virtual Reality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Collaborators
- Sakarya Applied Sciences University
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | – | Device: Virtual Reality based exercisesIndividuals 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. |
| control | – | –Individuals who receive traditional electrotherapy and exercise program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosed as having Adhesive Capsulitis and being treated in the rehabilitation center
Key inclusion criteria (2 listed)
- Being between the ages of 18-65
- Clinical diagnosis of adhesive capsulitis
Key exclusion criteria (3 listed)
- Inability to cooperate VR
- Surgery on the upper extremity or trunk
- Neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality based exercisesPlay VR games | Device | study |
Primary outcome
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.
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.
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).
1 secondary outcome
Shoulder mobility angles change
Time frame: Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Quality of Life, run by Kocaeli University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity change (time frame: Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.