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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979718
• Other study ID #: chhwang3
• Status: Completed
• Phase: N/A
• First received: November 3, 2013
• Last updated: June 15, 2016
• Start date: November 2013
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Ulsan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nociceptive Pain
• Osteoarthritis, Knee
• Virtual Reality

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Tridol consumption per week		after the 1st and 2nd session (5 days) intervention	No
Secondary	WOMAC index		shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention	No
Secondary	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	No
Secondary	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	No
Secondary	Side effects		after the 1st and 2nd session (5 days) intervention	No