Clinical trial NCT06201325: The Effects of Virtual Reality Based Exercises in Patients With Adhesive Capsulitis
Official title: Comparison of the Effectiveness of Virtual Reality Based Exercises and Conventional Physical Therapy in the Treatment of Adhesive Capsulitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: adhesive capsulitis
virtual reality
conventional physical therapy
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly divided into 3 groups. They will be selected by simple random sampling using the closed envelope method.

In the first group, will be included in a VR-based exercise program for half an hour a day, 5 days a week for a total of 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. These individuals will use the Microsoft Kinect for Azure VR system in the virtual environment.

In the second group, 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 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks.

In the third group, who will be included in the home exercise group, exercises will be taught to the patient and will be applied for half an hour a day, 5 days a week for a total of 3 weeks.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness of virtual reality based exercises and conventional physical therapy on shoulder pain, mobility, functional ability and quality of life in adhesive capsulitis and to investigate whether it is superior to the control group.

Detailed description: Adhesive capsulitis(AC) is an enigmatic condition characterized by painful, progressive and disabling loss of active and passive shoulder joint range of motion in multiple planes. Approximately 2% to 5% of adults between age 40 and 70 develop adhesive capsulitis with a greater occurrence in women and in individuals with thyroid disease or diabetes. AC is an arthroﬁbrosis involving the formation of excessive adhesions along the glenohumeral joint. It is a disease of unknown aetiology and is classified as primary and secondary. Primary adhesive capsulitis includes cases of idiopathic origin resulting from chronic inﬂammation with ﬁbroblast proliferation. Secondary adhesive capsulitis includes central nervous system problem, prolonged immobilisation of the arm, trauma or fracture, infectious diseases, etc. The progression of adhesive capsulitis is characterised by four stages, each stage showing a distinctive clinical presentation:

1. Painful phase: lasts less than three months and is characterised by shoulder pain at night with preserved glenohumeral motion.
2. Freezing phase: lasts three to nine months and is characterised by severe pain and stiffness in the glenohumeral joint.
3. Frozen shoulder process: lasts nine to fourteen months and is characterised by loss of movement and pain in all directions at the end.
4. Thawing phase: lasts fifteen to twenty-four months and is characterised by persistent stiffness, minimal pain, delayed recovery of shoulder movement.

Interventions for this pathology usually include physical therapy, nonsteroidal anti-inflammatory drug therapy, intra-articular steroid injections, distension arthrography and surgery. Physical therapy is the mainstay of treatment for patients with adhesive capsulitis. Conventional physical therapy consists of electrotherapy modalities such as TENS, Interferential current, Ultrasound, low intensity laser and exercises such as stretching exercises, Codman Exercise, Wand exercises and joint mobilisation and is used to control pain, increase flexibility and improve range of motion.

It is known that it takes a long time to achieve pain relief and a good improvement in ROM in adhesive capsulitis. This situation affects the quality of life of patients and creates a need for easily accessible treatment options that provide faster recovery.

One of the main challenges facing the therapist in the treatment of adhesive capsulitis is to motivate the patient throughout conventional therapy. As noted in a recent review, individuals are more interested in leisure activities rather than performing repetitive tasks during therapy. Virtual reality (VR) is a three-dimensional computer-aided programme built with a system that creates virtual reality movements and generates a high amount of visual and sensory feedback during exercise. As a result, virtual reality (VR) has been used in many medical indications and has been shown to promote adherence to treatment by increasing patient motivation.

Different VR systems have been shown to be effective in individuals with kinesiophobia as well as stroke patients. Virtual reality guided exercise is a proven method already used in stroke, Parkinson's, cerebral palsy rehabilitation, vestibular rehabilitation and orthopaedic rehabilitation. However, there is limited data on its effectiveness in patients with adhesive capsulitis. This randomized controlled study will contribute to the literature by investigating the effects of VR based exercises in individuals with AC.

The estimated number of volunteers expected to participate in the study was determined according to power analysis. The sample size of the study was determined by the GPower 3.1.9.7 program, and by using the finding in a similar study in the literature, it was used with 80% power and 5% margin of error to catch the medium effect size between dependent measurements. It was decided to work with a total of minimum 60 people, 20 in each group. Considering the patients who may be excluded from follow-up in the study, it is planned to start the study with 75 patients. The diagnosis of the disease will be made by history and clinical physical examination and no additional imaging technique will be required.

Patients will be randomly divided into 3 groups. They will be selected by simple random sampling using the closed envelope method, and then Group A (virtual reality + home exercise ), Group B (conventional therapy+ home exercise ) and Group C ( only home exercise ).

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 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. These individuals will use the Microsoft Kinect for Azure VR system in the virtual environment. They will play the registered games. These games will include purpose-oriented activities such as lying on the shelf 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 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. The exercises will be performed by a physiotherapist working in the clinic and blind to the study.

Individuals in the third group, who will be included in the home exercise group, exercises will be taught to the patient and will be applied for half an hour a day, 5 days a week for a total of 3 weeks.

The home exercise programme will be demonstrated by the physiotherapist at the beginning of the treatment and all groups will be asked to perform these exercises at home. Patients will be given a chart and they will be asked to mark this chart on the day they exercise. The exercise compliance of the patients will be monitored with this chart.

Home exercises will be organised as pendulum (Codman), finger ladder, Wand exercises, towel stretch and will be given to the patient as a visually printed exercise sheet.

Eligibility criteria: Inclusion Criteria:

* Aged between 18-65
* Clinical diagnosis of adhesive capsulitis
* Patients with loss of range of motion in a capsular pattern (external rotation \>abduction \> internal rotation)
* Participant signed informed consent

Exclusion Criteria:

* Surgery on the upper extremity or trunk
* Upper extremity injury in the last 6 months
* Injections in the shoulder area in the last 6 months
* Systemic or local infection of shoulder
* Uncontrolled hypertension
* Inability to cooperate VR
* Patient with malignancy
* Neurological disease

Primary outcomes:
measure: Visual analog scale
timeFrame: 0( baseline)
measure: Visual analog scale
timeFrame: 3th week
measure: Visual analog scale
timeFrame: 12th week
measure: Range of Motion
timeFrame: 0( baseline)
measure: Range of Motion
timeFrame: 3th week
measure: Range of Motion
timeFrame: 12th week
Secondary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 0( baseline)
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 3th week
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 12th week
measure: Modified Constant-Murley Score
timeFrame: 0( baseline)
measure: Modified Constant-Murley Score
timeFrame: 3th week
measure: Modified Constant-Murley Score
timeFrame: 12th week
measure: SF-36
timeFrame: 0( baseline)
measure: SF-36
timeFrame: 3th week
measure: SF-36
timeFrame: 12th week
Other outcomes:
Locations:
city: Kirşehir
country: Turkey
facility: Ahi Evran University
state: City Centre
Study officials:
affiliation: Kirsehir Ahi Evran Universitesi
name: Basak Cigdem KARACAY, assist prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sveistrup H, McComas J, Thornton M, Marshall S, Finestone H, McCormick A, Babulic K, Mayhew A. Experimental studies of virtual reality-delivered compared to conventional exercise programs for rehabilitation. Cyberpsychol Behav. 2003 Jun;6(3):245-9. doi: 10.1089/109493103322011524.
citation: Lee SH, Yeh SC, Chan RC, Chen S, Yang G, Zheng LR. Motor Ingredients Derived from a Wearable Sensor-Based Virtual Reality System for Frozen Shoulder Rehabilitation. Biomed Res Int. 2016;2016:7075464. doi: 10.1155/2016/7075464. Epub 2016 Aug 23.
citation: Gumaa M, Rehan Youssef A. Is Virtual Reality Effective in Orthopedic Rehabilitation? A Systematic Review and Meta-Analysis. Phys Ther. 2019 Oct 28;99(10):1304-1325. doi: 10.1093/ptj/pzz093.