The Effects of Immersive Virtual Reality in Patients With Grade 1-2 Adhesive Capsulitis

NCT07236229 | Recruiting

• 1 other identifier: BahcesehirU_H_AC-VR_01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adhesive Capsulitis; Virtual Reality; Sleep; Pain; Cognition

Keywords

Adhesive Capsulitis; Virtual Reality; Sleep; Pain; Cognition

Outcome Measures

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.

  Baseline and at the end of the 6-week intervention period

Secondary Outcomes (9)

• Shoulder Function (Shoulder Pain and Disability Index - SPADI)

  Baseline and at the end of the 6-week intervention period

• Shoulder Range of Motion (ROM)

  Baseline and at the end of the 6-week intervention period

• Pain Catastrophizing (Pain Catastrophizing Scale - PCS)

  Baseline and at the end of the 6-week intervention period

• Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)

  Baseline and at the end of the 6-week intervention period

• Digit Span Test

  Baseline and at the end of the 6-week intervention period

Study Arms (2)

Immersive Virtual Reality-Based Exercise Therapy

EXPERIMENTAL

Participants in this group will receive immersive virtual reality-based exercise therapy using Oculus Quest 2 applications (Guided Tai Chi and Reach Shoulder Health) for 6 weeks, 2 sessions per week.

Other: Immersive Virtual Reality-Based Exercise Therapy

Conventional Physiotherapy Group

ACTIVE COMPARATOR

Participants in this group will receive standard physiotherapy exercises for adhesive capsulitis including ROM, stretching, and strengthening for 6 weeks, 2 sessions per week.

Other: Conventional Physiotherapy Group

Interventions

Conventional Physiotherapy Group OTHER

In 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.

Conventional Physiotherapy Group

Immersive Virtual Reality-Based Exercise Therapy OTHER

Patients 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.

Immersive Virtual Reality-Based Exercise Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Suitable for using a VR headset

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Kanuni Sultan Suleyman Training and Research Hospital

Küçükçekmece, Istanbul, 34519, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Mena-Del Horno S, Balasch-Bernat M, Louw A, Luque-Suarez A, Rodriguez-Brazzarola P, Navarro-Ledesma S, Murillo C, Duenas L, Lluch E. Is there any benefit of adding a central nervous system-focused intervention to a manual therapy and home stretching program for people with frozen shoulder? A randomized controlled trial. J Shoulder Elbow Surg. 2023 Jul;32(7):1401-1411. doi: 10.1016/j.jse.2023.02.134. Epub 2023 Mar 29.

  PMID: 37001795 BACKGROUND

• Mertens MG, Meert L, Struyf F, Schwank A, Meeus M. Exercise Therapy Is Effective for Improvement in Range of Motion, Function, and Pain in Patients With Frozen Shoulder: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2022 May;103(5):998-1012.e14. doi: 10.1016/j.apmr.2021.07.806. Epub 2021 Aug 21.

  PMID: 34425089 BACKGROUND

• Hanchard NCA, Goodchild L, Brealey SD, Lamb SE, Rangan A. Physiotherapy for primary frozen shoulder in secondary care: Developing and implementing stand-alone and post operative protocols for UK FROST and inferences for wider practice. Physiotherapy. 2020 Jun;107:150-160. doi: 10.1016/j.physio.2019.07.004. Epub 2019 Jul 19.

  PMID: 32026815 BACKGROUND

• Demir OB, Kablanoglu S, Sari PN, Alyanak B, Taskin Yilmaz F, Dursun E. Effects of virtual reality exercise on pain, joint motion, and quality of life in patients with frozen shoulder: a randomized controlled study. Physiother Theory Pract. 2025 Jul;41(7):1435-1446. doi: 10.1080/09593985.2024.2443027. Epub 2024 Dec 19.

  PMID: 39700302 BACKGROUND

• Ozlu A, Ustundag S, Bulut Ozkaya D, Menekseoglu AK. Effect of Exergame on Pain, Function, and Quality of Life in Shoulder Impingement Syndrome: A Prospective Randomized Controlled Study. Games Health J. 2024 Apr;13(2):109-119. doi: 10.1089/g4h.2023.0108. Epub 2024 Feb 23.

  PMID: 38394299 BACKGROUND

MeSH Terms

Conditions

Bursitis; Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hande B Gocen, PhD (c)

  Istanbul Gelisim University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hande B Gocen, PhD (c)

CONTACT

5313606135; handegocen@outlook.com

Selen Gur Ozmen, Assoc.Prof.

CONTACT

5323941011; selen.gurozmen@bau.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, MSc Physiotherapist

Model Details: Patients will be divided into two groups using the stratified randomization method. The first group will be the immersive virtual reality-based exercise group (n=18), and the second group will be the conventional exercise group (n=18).

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 19, 2025
• Study Start: November 28, 2025
• Primary Completion: January 11, 2026
• Study Completion: February 27, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)