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.