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Completed

NCT Number: NCT01979718

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Nociceptive Pain Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Virtual Reality

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ulsan University Hospital

Ulsan, 682-714, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirrored Virtual reality

Device

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.

Primary outcomes

  1. 6 minute walk test

    Time frame: 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 outcomes

  1. Visual analogue scale (VAS) while resting

    Time frame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention

    checking the VAS while resting

  2. Visual analogue scale (VAS) while moving

    Time frame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention

    checking the VAS while resting

  3. Active ROM of flexion and extension on the knee

    Time frame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention

  4. Tridol consumption per week

    Time frame: after the 1st and 2nd session (5 days) intervention

  5. WOMAC index

    Time frame: shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention

  6. Graded ambulation distances

    Time frame: 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

  7. Timed-stands test

    Time frame: 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.

  8. Side effects

    Time frame: after the 1st and 2nd session (5 days) intervention

Sponsors and collaborators

Lead sponsor

Ulsan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 8, 2013
Registry last updated
Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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