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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04795011
Other study ID # SelcukUEC1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 9, 2021
Est. completion date April 22, 2021

Study information

Verified date May 2021
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this context, the purpose of our study is to investigate the effect of MLD(manual lymphatic drainage) technique applied in addition to the standard postoperative rehabilitation protocol on pain, kinesophobia and quality of life in early periods in patients undergoing primary TKA(total knee arthroplasty) surgery. Our hypothesis is that the addition of the MLD technique to the standard postoperative rehabilitation protocol will improve the early clinical outcomes of patients undergoing primary TKA. In the future perspective, we anticipate that the data obtained as a result of our study will make a significant contribution to the relevant literature on the early and mid-term ameliorative effects of MLD on postoperative pain, kinesiophobia and quality of life, which will be possibly applied in addition to standard postoperative rehabilitation protocols in patients undergoing primary TKA.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date April 22, 2021
Est. primary completion date March 9, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria: - Patients between the ages of 40-85 - were diagnosed with stage IV gonarthrosis - planned primary total knee arthroplasty (TKA) - were evaluated before the operation - whose informed consents Exclusion Criteria: - Patients with postoperative pulmonary thromboembolism or treatment-related complications in the past, - patients with osteoarthritis secondary bone or joint infections, - patients with morbid obesity, - patients with presence of hematological disease and malignancy, - major cardiac pathology, - venous insufficiency, - patients taking high-dose anticoagulants - patients with communication problems

Study Design


Related Conditions & MeSH terms


Intervention

Other:
exercise and manual lymphatic drainage
MLD will be launched with simple neck application. Hemodynamics of blood and lower extremity motoring will be increased by combining active bilateral shoulder-twisting with breathing after effleurage. Cervical lymph nodes will be stimulated. Back-up treatment will be applied for the abdominal area. Suction power in the ductus thoracicus will be increased with breathing exercises. Ventral drainage will be applied to the lower extremity in accordance with the surgery of the patient.
exercise
range of motion and walking exercise

Locations

Country Name City State
Turkey Selcuk University Konya Selcuklu

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tampa Kinesiophobia Scale The scale consists of 17 statements. Each statement contains the answers to strongly disagree, disagree, agree, strongly agree. While scoring according to the 4-point Likert scoring system, items 4, 8, 12, and 16 are subjected to reverse scoring. Scoring ranges from 17-68. As the score increases, the painful patient is considered to have an increase in kinesiophobia 10 minute
Primary Visual Analog Scale (VAS) It will be explained to the patients that "0" means "no pain" and "10" means "unbearable pain" on a 10 cm horizontal line. The patients will be asked to mark the pain of activity on the line with the help of a pencil. The values will be calculated with the help of a ruler in centimeters. 3 minute
Primary Nottingham Health Profile (NHP) The questionnaire consists of 38 questions consisting of 6 main topics, namely, energy level, pain, physical mobility, sleep, social isolation, and emotional reactions. The total score for each subtitle is 100, and the total score is obtained by adding the scores obtained from these subtitles. A low score indicates a high quality of life 10 minute
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