Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery (DLMOF)

October 19, 2018 updated by: University Hospital, Tours

Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery.Open-label Multicenter Randomized Controlled Trial

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.

Study Overview

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

120

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

      • Montpellier, France, 34295
        • UH Montpellier
      • Tours, France, 37044
        • UH Tours

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

14 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Orthognathic surgery (mandibular osteotomy, maxillary osteotomy or both)
  • Providing informed consent.

Exclusion Criteria:

  • Postoperative flexible restraint on the chin region.
  • Inability to understand and/or follow all scheduled visits.

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Manual Lymphatic Drainage
  • 9 daily sessions of manual lymphatic drainage (except on Saturday/Sunday) starting at Day 1 after surgery.
  • 4 more sessions (one every two days).
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.
NO_INTERVENTION: Control
No session of manual lymphatic drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of edema using a centimeter scale.
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.
day 22 after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort criteria
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).
Day 22
mental well-being.
Time Frame: day 22
The mental well-being will be assessed by the General Health Questionnaire in its 28 items french version (GHQ-28)
day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Axel DI VITTORIO, Mr, UH Tours
  • Study Chair: Julie LEGER, Mrs, UH Tours

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)

November 1, 2013

Primary Completion (ACTUAL)

October 1, 2018

Study Completion (ACTUAL)

October 1, 2018

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (ESTIMATE)

November 14, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2018

More Information

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.

Clinical Trials on Maxillofacial Abnormalities

Clinical Trials on Manual Lymphatic drainage

Subscribe