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Completed

NCT Number: NCT04795011

Outcomes for Manual Lymphatic Drainage

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.

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Key information

Conditions

Total Knee Arthroplasty Anxiety Disorders Kinesiophobia Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Phobic Disorders Signs and Symptoms

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

Konya, Selcuklu, 42130, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

exercise and manual lymphatic drainage

Other

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

Other

range of motion and walking exercise

Primary outcomes

  1. Tampa Kinesiophobia Scale

    Time frame: 10 minute

    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

  2. Visual Analog Scale (VAS)

    Time frame: 3 minute

    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. Nottingham Health Profile (NHP)

    Time frame: 10 minute

    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

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 12, 2021
Registry last updated
May 17, 2021

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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