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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04164927
Other study ID # GO15-152
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2015
Est. completion date January 1, 2016

Study information

Verified date November 2019
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Significant trauma and muscular tightness often result during Total Knee Arthroplasty (TKA) surgery and thus act to restrict tissue fluid movement resulting with lower extremity edema. Kinesio Taping® is applied directly on the skin for restoration of normal fluid perfusion, removing congestion of lymphatic fluid or hemorrhages. In addition Manual Lymphatic Drainage (MLD) enhances blood circulation and stimulates the lymphatic movement and unblocks lymphatic territories. The aim of the study was to investigate the effectiveness of Kinesio Taping® and MLD in reducing postoperative edema and pain in the early stage after TKA.


Description:

Procedures: Patients who underwent unilateral TKA were randomized as Kinesio TapingĀ® group, MLD group and control group. For all patients, postoperative rehabilitation program included early mobilization and physical therapy twice a day during the stay in orthopedic traumatology department. On the second day after surgery, lymphatic correction method was used on the Kinesio TapingĀ® group patients and a standardized 30-minute MLD treatment was applied to the MLD group patients. Control group received only physiotherapy treatment. Circumference measurements were applied on preoperatively and the second, third, fourth day and 6th weeks after surgery. Knee Injury and Osteoarthritis Outcome Score (KOOS) was used to determine the functional outcomes on the 6th weeks after surgery. Repeated measures of variance analysis was used to determine time differences between groups.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 1, 2016
Est. primary completion date August 30, 2015
Accepts healthy volunteers No
Gender All
Age group 45 Years to 90 Years
Eligibility Inclusion Criteria:

- TKA surgery

Exclusion Criteria:

- active infection

- malignant tumor

- major cardiac pathology, or thrombus or venous obstruction that was pre-diagnosed or revealed on a routine preadmission hospital screening

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Manual Lymphatic Drainage
Lymphatic correction method was used via the KinesioTaping® to patients group. Standardized 30-minute Manuel Lymphatic Drainage treatment was applied to the MLD group. Control group received only physiotherapy treatment.
Kinesio Taping
Depending on the size of the leg two or three fan cut tapes were applied with light paper-off tension on the frontal, medial and lateral aspects of the limb. Kinesio taping was applied by certified Kinesio Tape practitioner once a week to Kinesiotaping group.
Control
Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures. These exercises were undertaken in sets of 10 repetitions, 3 times daily; the physiotherapist was present to assist, as required, on 2 occasions per day for the first 3 postoperative days and then once daily from day 4 until hospital discharge.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

References & Publications (2)

Ebert JR, Joss B, Jardine B, Wood DJ. Randomized trial investigating the efficacy of manual lymphatic drainage to improve early outcome after total knee arthroplasty. Arch Phys Med Rehabil. 2013 Nov;94(11):2103-11. doi: 10.1016/j.apmr.2013.06.009. Epub 2013 Jun 26. — View Citation

Pichonnaz C, Bassin JP, Lécureux E, Christe G, Currat D, Aminian K, Jolles BM. Effect of Manual Lymphatic Drainage After Total Knee Arthroplasty: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 May;97(5):674-82. doi: 10.1016/j.apmr.2016.01.006. Epub 2016 Jan 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Circumference measurements Circumference measurements This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery
Secondary Knee Injury and Osteoarthritis Outcome Score (KOOS) Knee Injury and Osteoarthritis Outcome Score (KOOS) evaluates the functional status of knee joint. total points range between 0-100 points. higher points represents a better outcome. total score is the averaged subscales. This outcome measure is assessing a change from the postoperative day 2 at 3rd month after surgery
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