Nociceptive Pain, Osteoarthritis, Knee, Virtual Reality
Conditions
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.
Interventions
DEVICEMirrored 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.
Sponsors
Ulsan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
| 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 |
| 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 |
| 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 | — |
| WOMAC index | shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention | — |
Countries
South Korea
Outcome results
None listed