Drainage/Methods Clinical Trial
Official title:
The Effect of Manual Lymphatic Drainage on Swelling After Orthognathic Surgery - a Qualitative and 3D Facial Analysis.
Introduction / background
Orthognathic surgery is an operation in which one or both jaws are fixed in a more favorable
position performed by an osteotomy. In this way, large skeletal differences between the upper
and lower jaw can be corrected surgically. The aim is to obtain a good and stable occlusion
as well as to improve the facial aesthetics off the patient, where this would not be possible
without surgery. These surgical procedures are accompanied by swelling of the face that can
last for several days. The swelling is often considered unpleasant by the patients. The
post-operative application of ice on the face can reduce the swelling. Also, performing
manual lymphatic drainage (MLD) at the head and neck region would have a positive effect on
the swelling after the operation. Manual lymphatic drainage is a kind of gentle massage
performed by physiotherapists to reduce swelling in a faster way after surgery. This therapy
is performed during the first days after the surgery and lasts about 30 minutes per session.
There is still insufficient evidence to be whether or not this technique offers added value
for patients undergoing jaw surgery.
Goal
The aim of this study is to investigate whether or not manual lymphatic drainage provides
added value for patients undergoing jaw surgery. The facial swelling will be studied as the
primary outcome variable. Other postoperative discomforts associated with orthognathic
surgery are the secondary outcome variables. This study may or may not justify performing MLD
and ensure that it is included in a postoperative protocol.
Methodological approach
The investigators would like to measure and compare the swelling in the face in an objective
way between patients who received manual lymphatic drainage (intervention group) and patients
who did not undergo manual lymphatic drainage (control group) The control group receives the
standard postoperative care that is applied at the University Hospital Ghent. The
intervention group also receives the same postoperative cares, as well as 5 MLD sessions
during the first postoperative week (1st, 2nd, 3rd, 4th, 7th postoperative day).The objective
measurement of the swelling can be done on the basis of a laser scan that can create 3D
images of the face. For this, the patient should take a natural head position at rest and
have a relaxed facial expression. This technique of imaging is non-invasive and there is no
x-ray radiation involved! The 3D images are taken at the following times: 3 days, 1 week, 2
weeks, 1 month, 3 months and 6 months after the operation. Together with the scans, the
patients were asked to fill in a questionnaire to frame the subjective postoperative
discomfort associated with orthognathic surgery.
The change in swelling can be analyzed on the basis of specific measurements on the 3D images
as well as by recording surface changes. The last 3D image is used as a reference to
superimpose the other 3D images as there is no longer any swelling on this 3D image. After
analyzing these data, it can be assessed to what extent manual lymphatic drainage offers an
advantage to reduce swelling after orthognathic surgery.
Subjects
The patients were collected from the maxillofacial department of the University Hospital of
Ghent, Belgium between January 2015 and March 2018. The subjects had to meet certain
inclusion criteria to participate in this study and they were rejected if one of the
mentioned exclusion criteria was presented.
Inclusion criteria:
1. Age 14 - 65 years
2. ASA score I
3. BSSO, LeFort I or Bimax
Exclusion criteria:
1. Transgender patients
2. Other facial surgery's
3. Deviant medication
4. Cleft patients
5. Lot of facial hair
6. Refused to participate
Next, patients who met all inclusion criteria and didn't drop out because of the exclusion
criteria, were randomized in 2 treatment groups by block randomization. One group received
the conventional postoperative cares from the University Hospital Ghent including topical ice
application (also called cryotherapy), standardized medication and postoperative
instructions. These patients were used as controls. The other group received the same
conventional postoperative cares as mentioned in the control group, but also underwent 5
sessions of MLD after the operation. Starting on the 1st postoperative day. These patients
belonged to the intervention group.
Protocol
For every postoperative visit there was a fixed flowchart that needed to be followed. First
the patient was asked to fill in the survey which questioned the pain and swelling. When this
was done, a 3D face scan was taken of the untouched face in a natural resting position with a
laser scanner (Planmeca Proface®, Planmeca Oy, Finland). Thereafter, only the intervention
group received a MLD session if indicated by the protocol. Finally, the appointments for the
future were checked in order to prevent no-shows. The last visit of every patient was planned
6 months after surgery.
Ethical approval
The study was submitted to the research ethics board of the University Hospital of Ghent and
a positive advise was given for this protocol. The study has also been registered (no.
B670201629310). A written informed consent was obtained from each subject after the
researcher explained the purpose and the procedure of the study containing the possible risks
and benefits associated with the interventions.
Manual Lymph drainage
The MLD sessions were performed by 3 masters in physiotherapy (5th years) who were specially
calibrated for this study by the same experienced MLD instructor and physiotherapist
(V.V.B.). The used method for MLD was these described by Dr. Vodder and is a rather soft kind
of massage that lasts for about 40 minutes per session. All MLD session were performed in a
pleasant temperature and in an extremely relaxed atmosphere. In order to achieve this, it was
requested not to talk during treatment. Also all patients were in a comfortable lying
position when the MLD was performed.
Questionnaire
Before taking the face scans, a questionnaire was always filled out by the patient. These
questionnaires were created with the aim to give an idea of the perceived swelling and pain.
At the end, six questionnaires were collected per patient as prescribed by the protocol.
Pain scores were assessed using a visual analogue scale (VAS) of 100 mm, representing all
pain sensations from none to maximum. Zero mm indicates no pain, 50 mm moderate pain and 100
mm worst pain possible. Patients were asked to place a mark along the line that corresponded
to the amount of pain they were experiencing. In this questionnaire, two visual analogue
scales were used to question the average pain of the last 24 hours and the worst pain of the
last 24 hours.
To measure the swelling in an subjective way, a five-point Likert-type scale was used. The
patients were asked whether they suffered from swelling in the last 24 hours. Five possible
answers could be checked: none, almost none, moderate, pretty much and very much.
Face scan and processing
Six face scans were taken from each patient with the Planmeca Proface® (Planmeca Oy, Finland)
as indicated by the protocol. This technique of imaging is non-invasive and there is no x-ray
radiation involved! The face scans were transformed into STL files and subsequently exported
to software programs.
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