NCT Number: NCT01983436
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.
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Notify Me14 year–50 year
All sexes
Interventional
Not applicable
UH Montpellier, Montpellier, France
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: day 22 after surgery
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
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
The mental well-being will be assessed by the General Health Questionnaire in its 28 items french version (GHQ-28)
University Hospital, Tours
Other
Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery.Open-label Multicenter Randomized Controlled Trial
Acronym: DLMOF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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