The Post-operative Analgesia of the Virtual Reality Using a Mirror Therapy After Total Knee Arthroplasty

The Post-operative Analgesia of the Virtual Reality Using a Mirror Therapy After Total Knee Arthroplasty: Prospective, Single-blind, Parallel Group, Randomized, Single Cohort Clinical Trial of Efficacy

It was well known that the mirror therapy could decrease pain of upper-limb amputated patients.

The mirror therapy is known to make a plastic change some parts of the brain perceiving the painful body part and modulating its signal by feedback of visual information mirrored with the corresponding contra-lateral normal parts.

In this study, post-operative analgesic efficiency of the virtual reality using a mirror therapy after total knee arthroplasty will be evaluated.

This clinical trial will be performed in the form of prospective, single-blind (i.e. assessor-blind), parallel group, randomized (allocation ratio 1:1), single cohort.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee; Virtual Reality; Nociceptive Pain
• Intervention / Treatment: Device: Mirrored Virtual reality

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ulsan, Korea, Republic of, 682-714
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients who were transferred to RM after unilateral TKA

Exclusion Criteria:

• patients cannot freely move the contralat. leg d/t neurologic or musculoskeletal problems
• patients are not enough clear to indicate VAS
• patients cannot look at the virtual reality monitor d/t visual problem
• refusal of the participation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full term intervention; random selection; composed of the daily standard physical treatment and 1 session per one day over two weeks with a break on Saturday and Sunday (1 session is consisted of 50 repetitions of voluntary simultaneous flexion and extension of the both knees, taking a look at the mirrored virtual reality simulating the surgeried knee.	Device: Mirrored Virtual reality; Patients are required to look at the images of both lower extremities ranged from the perineal area to the foot. Virtual reality system records in real-time method both lower extremities. Following the validity assessement mirrored image of the surgeried lower extremity is re-formed using the virtusal reality system flipping the image of lower extremity not-surgeried and being calibration for the symmetricity.
Active Comparator: Half term intervention; random selection; composed of the daily standard physical treatment over two weeks and 1 session per one day over one weeks with a break on Saturday and Sunday (1 session is consisted of 50 repetitions of voluntary simultaneous flexion and extension of the both knees, taking a look at the mirrored virtual reality stimmulating the surgeried knee )	Device: Mirrored Virtual reality; Patients are required to look at the images of both lower extremities ranged from the perineal area to the foot. Virtual reality system records in real-time method both lower extremities. Following the validity assessement mirrored image of the surgeried lower extremity is re-formed using the virtusal reality system flipping the image of lower extremity not-surgeried and being calibration for the symmetricity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walk test	The distance walked at a self-selected speed along a 40 cm corridor in 6 min. The distance was measured in meters, and more the meters better the result. A walking aid was used if needed.	shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale (VAS) while resting	checking the VAS while resting	shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Visual analogue scale (VAS) while moving	checking the VAS while resting	shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Active ROM of flexion and extension on the knee		shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Tridol consumption per week		after the 1st and 2nd session (5 days) intervention
WOMAC index		shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Graded ambulation distances	Grade 1: able to ambulate ≤5 feet Grade 2: able to ambulate >5 feet but <10 feet Grade 3: able to ambulate >10 feet but <30 feet Grade 4: able to ambulate ≥30 feet	shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Timed-stands test	The patients were asked to rise from and sit down on a chair with a height of 45 cm, 10 times and as quickly as possible, without using the armrests. The time spent was recorded.	shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Side effects		after the 1st and 2nd session (5 days) intervention

Collaborators and Investigators

• Sponsor: Ulsan University Hospital
• Investigators: Principal Investigator: Chang Ho Hwang, M.D., Ph.D., Ulsan University Hospital; Principal Investigator: Sung Do Cho, M.D., Ph.D., Ulsan University Hospital; Principal Investigator: Youngjoon Chee, Ph.D., Department of Biomedical Engineering, University of Ulsan; Principal Investigator: Kyo-In Koo, Ph.D., Department of Biomedical Engineering, University of Ulsan

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 3, 2013
• First Submitted That Met QC Criteria: November 3, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Estimate): June 16, 2016
• Last Update Submitted That Met QC Criteria: June 15, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Nociceptive Pain
• Other Study ID Numbers: chhwang3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED