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Completed

NCT Number: NCT05398549

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.

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Key information

Conditions

Adhesive Capsulitis Bursitis Joint Diseases Musculoskeletal Diseases

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Services Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of diabetes mellitus
  • Any history of previous upper limb fracture
  • Received steroids injection in the shoulder
  • Any history of systematic or malignant disease

Treatment and study plan

Conventional physical therapy

Other

Subjects in group A was treated with conventional physical therapy i.e. grade 1 and 2 mobilization and stretching exercise

Virtual Reality Group

Other

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.

Primary outcomes

  1. Visual Analogue Scale

    Time frame: 4 weeks

    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.

  2. ROM Shoulder flexion (right)

    Time frame: 4 weeks

    Changes from the Baseline ROM range of Motion of Shoulder flexion was taken with the Help of Goniometer

  3. ROM Shoulder flexion (left)

    Time frame: 4 weeks

    Changes from the Baseline ROM range of Motion of Shoulder flexion was taken with the Help of Goniometer

  4. ROM Shoulder External rotation(right)

    Time frame: 4 weeks

    Changes from the Baseline ROM range of Motion of Shoulder External rotation was taken with the Help of Goniometer

  5. ROM Shoulder External rotation(left)

    Time frame: 4 weeks

    Changes from the Baseline ROM range of Motion of Shoulder External rotation was taken with the Help of Goniometer

  6. ROM Shoulder Abduction(right)

    Time frame: 4 weeks

    Changes from the Baseline ROM range of Motion of Shoulder Abduction was taken with the Help of Goniometer

  7. ROM Shoulder Abduction(left)

    Time frame: 4 weeks

    Changes from the Baseline ROM range of Motion of Shoulder Abduction was taken with the Help of Goniometer

  8. Shoulder Pain and Disability Index

    Time frame: 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2022
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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