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
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 |
Verified date | May 2021 |
Source | Selcuk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Selcuk University | Konya | Selcuklu |
Lead Sponsor | Collaborator |
---|---|
Selcuk University |
Turkey,
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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