Clinical trial NCT05961033: The Effects of Virtual Reality Based Exercises in Patients With Adhesive Capsulitis
Official title: The Effects of Virtual Reality Based Exercises on Pain, Range of Motion and Quality of Life in Patients With Adhesive Capsulitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Quality of Life
Range of Motion
Virtual Reality
Lead sponsor: Kocaeli University
Sponsor class: OTHER
Collaborators: name: Sakarya University of Applied Sciences
First posted: 2023-07-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Diagnosed as having Adhesive Capsulitis and being treated in the rehabilitation center

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain severity change
timeFrame: Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises
measure: Quality of Life level change
timeFrame: Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises
measure: Shoulder functionality level change
timeFrame: Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises
Secondary outcomes:
measure: Shoulder mobility angles change
timeFrame: Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University Faculty of Medicine Hospital
city: Sakarya
country: Turkey
facility: Sakarya University Physiotherapy and Rehabilitation Research Center
Study officials:
References: