An interventional study of Manual Lymphatic drainage in Maxillofacial Abnormalities and Post Procedural Discharge, sponsored by University Hospital, Tours. Completed at 2 sites in France. Open to participants aged 14 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-10-23.
Sponsored by University Hospital, Tours · Not applicable, Interventional, and Supportive care
Orthognathic surgery aims to standardize position of the maxilla and the mandible and therefore chewing, breathing, phonation and swallowing functions. In postoperative, several physical and functional consequences are observed in patients: transient edema of the face, maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain and sensory disturbances (labial or/and chin paresthesias).
Achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease of postoperative edema, improved postoperative comfort and mental well-being.
The main objective of this study is to evaluate the efficacy of sessions of manual lymphatic drainage to reduce postoperative edema.
Orthognathic surgery aims to standardize position of the maxilla and the mandible and therefore chewing, breathing, phonation and swallowing functions. In postoperative, several physical and functional consequences are observed in patients: transient edema of the face, maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain and sensory disturbances (labial or/and chin paresthesias).
Achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease of postoperative edema, improved postoperative comfort and mental well-being.
The main objective of this study is to evaluate the efficacy of sessions of manual lymphatic drainage to reduce postoperative edema. Secondary objectives of the study are to assess impact of sessions of manual lymphatic drainage on patient comfort (pain, aesthetic discomfort, difficulty in breathing and discomfort in swallowing) and on ental well-being.
Patients allocated to the intervention group will have 13 sessions of manual lymphatic drainage and those allocated in control group will not.
Edema of patients will be measured at day 1, day 8, day 15 and day 22 after surgery by a different physiotherapist than physiotherapist achieving drainage sessions, blind to the randomization group of the patient. At the same time, comfort criteria will be assessed by a visual analogue scale and mental well-being with the General Health Questionnaire (GHQ28).
21 studies on the registry are indexed under Maxillofacial Abnormalities; 2 are open to participants now.
This study's enrollment of 120 is above the median of 49 across 10 interventional studies indexed under Maxillofacial Abnormalities.
Browse Maxillofacial Abnormalities studies →University Hospital, Tours is the lead sponsor of 307 studies on the registry; 79 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 9 daily sessions of manual lymphatic drainage (except on Saturday/Sunday) starting at Day 1 after surgery. * 4 more sessions (one every two days).
Other: Manual Lymphatic drainage
No session of manual lymphatic drainage
Manual lymphatic drainage of the face and the neck is a massage technique that aims to remove an edema of this anatomical region. The technique consists to stimulate the lymph nodes in order to accelerate the lymph flow and to achieve a specific massage to promote the entry of lymph nodes in the initial lymphatics. Massages follow anatomical pathways of vessels and of lymph nodes of the head and the neck. The technique should be smooth and painless.
Assessment of edema using a centimeter scale.
Assessment in centimeter of the distance between the ear lobes passing under the bottom of the columella, through the chin and passing under the bottom edge of the chin and assessment in centimeter of the neck circumference at 7.5 cm below the lobes ears.
Time frame: day 22 after surgery
Comfort criteria
Comfort criteria (pain, aesthetic discomfort, difficulty in breathing and discomfort in swallowing) will be assessed by a self-administered questionnaire consisting of visual analogue scale(0-10).
Time frame: Day 22
mental well-being.
The mental well-being will be assessed by the General Health Questionnaire in its 28 items french version (GHQ-28)
Time frame: day 22
Ran from Nov 2013 to primary completion in Oct 2018, 59 months.
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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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