The Effects of Immersive Virtual Reality in Patients With Grade 1-2 Adhesive Capsulitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBahçeşehir University
About this trial
Adhesive capsulitis (frozen shoulder) is a complex condition characterized by inflammation, fibrosis, and restriction of movement in the shoulder capsule, significantly limiting an individual's participation in daily living activities. It is most commonly observed in individuals aged between 40 and 60 years, and its treatment frequently involves approaches such as manual therapy, exercise, corticosteroid injections, and electrotherapy. However, these conventional methods may be limited by factors such as lack of motivation, pain-related avoidance behavior, and poor treatment adherence.
Today, immersive virtual reality technologies introduce a new dimension to rehabilitation by gamifying exercise, providing sensory feedback, and enabling graded exposure through mechanisms such as distraction and engagement. They also enhance motivation and compliance with exercise programs. Studies in the literature have reported that virtual reality-based exercise is an effective method for reducing pain levels in patients diagnosed with frozen shoulder.
However, only a limited number of studies have specifically examined the effects of immersive virtual reality in patients with adhesive capsulitis. To date, no study has investigated the impact of immersive virtual reality interventions on sleep and cognitive functions in these patients. Furthermore, the combined effect of patient education, home exercise programs, and immersive virtual reality therapy has not yet been explored. For these reasons, the present study aims to investigate the effects of immersive virtual reality-based exercise therapy on pain, functionality, sleep, and cognitive functions in patients with Grade 1-2 adhesive capsulitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with adhesive capsulitis by a doctor
Classified as Grade 1-2 adhesive capsulitis
Receiving physiotherapy for adhesive capsulitis for the first time
Aged between 18 and 64 years
Disqualifiers
Previous history of physiotherapy
Presence of any mental disorder
Recent surgery or any shoulder condition (e.g., fractures around the shoulder region) that contraindicates shoulder mobilization
History of receiving injections
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional Physiotherapy Group
Other interventionIn the conventional exercise group, participants will perform range of motion exercises, pendulum exercises, finger ladder exercises, stretching, and strengthening exercises. The traditional exercise therapy will be administered twice a week for six weeks, with each session lasting 30 minutes. In addition, both groups will receive identical patient education and home exercise programs. Patient education will be delivered face-to-face for 30 minutes at the beginning of the intervention. The home exercise program will be performed progressively at home on non-intervention days, five days per week.
Immersive Virtual Reality-Based Exercise Therapy
Other interventionPatients in the immersive virtual reality-based exercise group will participate in the exercise program using the Oculus Quest 2 device. Sessions will be conducted twice a week for six weeks, each lasting 30 minutes. Two different virtual reality applications, Reach Shoulder Health and Guided Tai Chi, will be administered to the patients in this group. In addition, both groups will receive identical patient education and home exercise programs. Patient education will be delivered face-to-face for 30 minutes at the beginning of the intervention. The home exercise program will be performed progressively at home on non-intervention days, five days per week.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Immersive Virtual Reality-Based Exercise TherapyExperimental treatment 1 intervention
Group B: Conventional Physiotherapy GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain intensity measured by the Visual Analog Scale (VAS)
The VAS assesses perceived shoulder pain intensity on a 10-cm line from "no pain" to "worst pain imaginable.
Time frame
Baseline and at the end of the 6-week intervention periodSecondary outcomes
1
Shoulder Function (Shoulder Pain and Disability Index - SPADI)
Shoulder pain and disability will be assessed with the SPADI, which evaluates pain and functional limitation on a 0-100 scale, where higher scores indicate greater impairment.
Time frame
Baseline and at the end of the 6-week intervention period2
Shoulder Range of Motion (ROM)
Shoulder joint mobility (flexion, extension, abduction, adduction, internal and external rotation) will be measured in degrees using a goniometer to evaluate changes in movement capacity.
Time frame
Baseline and at the end of the 6-week intervention period3
Pain Catastrophizing (Pain Catastrophizing Scale - PCS)
Catastrophic thinking related to pain will be assessed using the PCS, which measures rumination, magnification, and helplessness. Total scores range from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.
Time frame
Baseline and at the end of the 6-week intervention period4
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)
The PSQI assesses sleep quality over the past month across seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Component scores (0-3) are summed to yield a global score (0-21), with higher scores indicating poorer sleep quality (commonly, \>5 suggests poor sleep).
Time frame
Baseline and at the end of the 6-week intervention periodSponsors and contacts
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Source ClinicalTrials.gov