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

NCT01983436 | Completed

• 1 other identifier: PHRIP/12/ADV/DLMOF
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Maxillofacial Abnormalities; Post Procedural Discharge

Keywords

Maxillofacial Orthognathic Surgery; Manual lymphatic drainage

Outcome Measures

Primary Outcomes (1)

• 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.

  day 22 after surgery

Secondary Outcomes (2)

• Comfort criteria

  Day 22

• mental well-being.

  day 22

Study Arms (2)

Manual Lymphatic Drainage

EXPERIMENTAL

* 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

Control

NO INTERVENTION

No session of manual lymphatic drainage

Interventions

Manual Lymphatic drainage OTHER

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.

Manual Lymphatic Drainage

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (2)

UH Montpellier

Montpellier, 34295, France

Location

UH Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Maxillofacial Abnormalities

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Officials

• Axel DI VITTORIO, Mr

  UH TOURS

  PRINCIPAL INVESTIGATOR

• Julie LEGER, Mrs

  UH Tours

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: November 14, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

FR (2)