Clinical trial NCT01979718: The Post-operative Analgesia of the Virtual Reality Using a Mirror Therapy After Total Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Nociceptive Pain
Virtual Reality
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 6 minute walk test
timeFrame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
Secondary outcomes:
measure: Visual analogue scale (VAS) while resting
timeFrame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
measure: Visual analogue scale (VAS) while moving
timeFrame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
measure: Active ROM of flexion and extension on the knee
timeFrame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
measure: Tridol consumption per week
timeFrame: after the 1st and 2nd session (5 days) intervention
measure: WOMAC index
timeFrame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
measure: Graded ambulation distances
timeFrame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
measure: Timed-stands test
timeFrame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention
measure: Side effects
timeFrame: after the 1st and 2nd session (5 days) intervention
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Ulsan University Hospital
name: Chang Ho Hwang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ulsan University Hospital
name: Sung Do Cho, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Biomedical Engineering, University of Ulsan
name: Youngjoon Chee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Biomedical Engineering, University of Ulsan
name: Kyo-In Koo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: