Outcomes for Manual Lymphatic Drainage

Total Knee Arthroplasty Clinical Trial

Official title:

Additional Manual Lymph Drainage to Standard Postoperative Rehabilitation Protocol in Primary Total Knee Arthroplasty Patients Improves Postoperative Kinesiophobia, Pain and Quality of Life: Preliminary Clinical Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04795011
• Other study ID #: SelcukUEC1
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

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