- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04795011
Outcomes for Manual Lymphatic Drainage
May 14, 2021 updated by: Emine Cihan, Selcuk University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Selcuklu
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Konya, Selcuklu, Turkey, 42130
- Selcuk University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 83 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: control group
Standard rehabilitation protocol will be administered to the control group.
In the standard rehabilitation protocol for the first three days after surgery, 3 sets of exercises will be applied as 10 repetitions.
The treatment will be initiated for the patients with tolerable coughing and deep breathing exercises.
Active dorsi-plantar flexion of the ankle, isometric contraction for the quadriceps, hamstrings and gluteus maximus, for the knee in the supine position on the bed; active heel shift exercises, straight leg raising and standing knee and hip flexion, active hamstring curling, and self-hamstring stretching will be performed.
After the exercise, the morning treatment protocol will be completed with a walker at a tolerable distance.
The patient will be given assignment in the form of walking and repetition of morning exercises at a tolerable level at least twice during the day.
|
range of motion and walking exercise
|
Experimental: manual lymphatic drainage group
manual lymphatic drainage (MLD) will be applied to the second group (MLD group) in addition to the standard rehabilitation protocol
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
10 minute
|
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 minute
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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
|
10 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2021
Primary Completion (Actual)
March 9, 2021
Study Completion (Actual)
April 22, 2021
Study Registration Dates
First Submitted
March 9, 2021
First Submitted That Met QC Criteria
March 9, 2021
First Posted (Actual)
March 12, 2021
Study Record Updates
Last Update Posted (Actual)
May 17, 2021
Last Update Submitted That Met QC Criteria
May 14, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- SelcukUEC1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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