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

Not Applicable

Completed

• Conditions: Virtual Reality; Nociceptive Pain; Osteoarthritis, Knee
• Interventions: Device: Mirrored Virtual reality

• Registration Number: NCT01979718
• Lead Sponsor: Ulsan University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-03
• Study First Submitted QC: 2013-11-03
• Study First Posted: 2013-11-08
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-15
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Half term intervention	Mirrored Virtual reality	* 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 )
Full term intervention	Mirrored Virtual reality	* 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.

Primary Outcome Measures

Name	Time	Method
6 minute walk test	shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention	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.

Secondary Outcome Measures

Name	Time	Method
Tridol consumption per week	after the 1st and 2nd session (5 days) 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
Timed-stands test	shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention	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.
Side effects	after the 1st and 2nd session (5 days) intervention
Visual analogue scale (VAS) while resting	shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention	checking the VAS while resting
Visual analogue scale (VAS) while moving	shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention	checking the VAS while resting
WOMAC index	shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Graded ambulation distances	shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention	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

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of