Effects of Virtual Reality in Adhesive Capsulitis on Pain, Range of Motion and Function

Adhesive capsulitis (AC) also known as frozen shoulder typically manifests to decrease range of motion (ROM) and function and increase pain in shoulder. Objective of this study is to find the effects of virtual reality (VR) in adhesive capsulitis on pain, range of motion and function to decrease pain and improve range of motion and function. The study design will be a quasi-experimental study that will be used to compare the effects of virtual reality with conventional physical therapy. Subjects with adhesive capsulitis meeting the predetermined inclusion & exclusion criteria will be divided into two groups using lottery method. Pre assessment will be done using visual analogue scale (VAS), shoulder pain and disability index (SPADI) tool and active shoulder flexion and abduction as subjective measurements. Subjects in group A will be treated with virtual reality stimulation given for 30 minutes per session through kinetic Xbox with sensory accelerator model no.1414. Two traditional training activities will be used to improve shoulder Range of motion i.e. shoulders finger ladder training activity and single curved shoulder training activity 12 times (3 rounds in each practice) of the training 1 . Patients will be required to complete standard training task by interacting with designed VR rehabilitative training games under the supervision of physical therapists and subjects in group B will be treated with conventional physical therapy i.e. grade 1 and 2 mobilization and stretching exercise. Baseline treatment protocol hot pack will be applied to both groups.

Treatment duration for both groups will be 30 minutes. Each subject will receive a total 6 week protocol with 02 treatment sessions per week. Post treatment reading will be recorded after the end of 2 nd , 4th and 6th treatment weeks. Recorded values will be analyzed for any change using SPSS 21.

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis
• Intervention / Treatment: Other: Conventional Physical therapy; Other: Virtual reality group

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Services Hospital, Lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ranges between 25 to 60
2. Both gender were included
3. Primary idiopathic type
4. No eyesight problems
5. Normal cognition and could follow instructions when using the system (score of 20 or more in mini mental state examination)
6. Clinically confirmed to ensure frozen shoulders through perform different physical tests i.e. speed tests, empty can test etc

Exclusion Criteria:

1. History of diabetes mellitus
2. Any history of previous upper limb fracture
3. Received steroids injection in the shoulder
4. Any history of systematic or malignant disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional physical therapy; Subjects in group A was treated with conventional physical therapy i.e. grade 1 and 2 mobilization and stretching exercise.	Other: Conventional Physical therapy; Subjects in group A was treated with conventional physical therapy i.e. grade 1 and 2 mobilization and stretching exercise
Experimental: Virtual reality group; group B was treated with virtual reality stimulation given for 30 minutes per session through kinetic Xbox with sensory accelerator model no.1414.Two traditional training activities was used to improve shoulder Range of motion i.e. badminton and American baseball activity 12 times of the training Baseline treatment protocol hot pack and ultrasound was applied to both groups. Treatment duration for both groups was 30 minutes. Each subjects were receive a total 4 week protocol with 03 treatment sessions per week.	Other: Virtual reality group; group B was treated with virtual reality stimulation given for 30 minutes per session through kinetic Xbox with sensory accelerator model no.1414. Two traditional training activities was used to improve shoulder Range of motion i.e. badminton and American baseball activity 12 times of the training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	Changes from the Baseline Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to mark their current pain level on the line. They can also be asked to mark their maximum, minimum, and average pain.	4 weeks
ROM Shoulder flexion (right)	Changes from the Baseline ROM range of Motion of Shoulder flexion was taken with the Help of Goniometer	4 weeks
ROM Shoulder flexion (left)	Changes from the Baseline ROM range of Motion of Shoulder flexion was taken with the Help of Goniometer	4 weeks
ROM Shoulder External rotation(right)	Changes from the Baseline ROM range of Motion of Shoulder External rotation was taken with the Help of Goniometer	4 weeks
ROM Shoulder External rotation(left)	Changes from the Baseline ROM range of Motion of Shoulder External rotation was taken with the Help of Goniometer	4 weeks
ROM Shoulder Abduction(right)	Changes from the Baseline ROM range of Motion of Shoulder Abduction was taken with the Help of Goniometer	4 weeks
ROM Shoulder Abduction(left)	Changes from the Baseline ROM range of Motion of Shoulder Abduction was taken with the Help of Goniometer	4 weeks
Shoulder Pain and Disability Index	Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with ADLs requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. The pain scale is summed up to a total of 50 while the disability scale sums up to 80. The total SPADI score is expressed as a percentage. A score of 0 indicates best 100 indicates worst. A higher score shows more disability. In scoring SPADI, any question missed should be taken out of the total score of each subscale. i.e if 1 question is omitted in the pain section, the total score is divided by 40.	4 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Tehreem Mukhtar, PP-DPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Virtual Reality ,Adhesive Capsulitis , Range of Motion
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: REC/Lhr//19/2020 Sana Inyat

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No