Myofunctional Therapy in Facial Palsy - Full Text View

Purpose

Objective: Quantify the benefits of myofunctional therapy associated to botulinum toxin injection in patients with long standing facial unilateral palsy.

Condition	Intervention
Facial Paralysis	Drug: Botulinum Toxin Type A Procedure: myofunctional therapy


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Improvement of Facial Symmetry With Myofunctional Therapy Combined to Botulinum Toxin Injections in Long Standing Facial Paralysis

Resource links provided by NLM:

MedlinePlus related topics: Bell's Palsy Botox Paralysis

Drug Information available for: OnabotulinumtoxinA

Genetic and Rare Diseases Information Center resources: Bell's Palsy

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:

Clinical score [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Facial Disability Index (self-report instrument) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]


Enrollment:	25
Study Start Date:	January 2005
Study Completion Date:	December 2006
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A: myofunctional prior to botulinum All the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group A, botulinum toxin was applied after myofunctional therapy.	Drug: Botulinum Toxin Type A All the patients received a one-time treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol,the total dose used per patient ranged from 15-69U, mean 37.9±5.4U. Other Name: BOTOX (Allergan) Procedure: myofunctional therapy All the patients were submitted to individual myofunctional therapy with the speech therapist, once a week, by four weeks.The myofunctional therapy began with isometric maneuvers for muscular elongation on the non paralyzed side, and on the paralyzed side when microsurgical reconstruction was present. It also included isotonic maneuvers to increase muscle tonus and isokinetic maneuvers to increase force on the paralyzed side.
Active Comparator: B: myofunctional after botulinum All the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group B, botulinum toxin was applied before myofunctional therapy.	Drug: Botulinum Toxin Type A All the patients received a one-time treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol,the total dose used per patient ranged from 15-69U, mean 37.9±5.4U. Other Name: BOTOX (Allergan) Procedure: myofunctional therapy All the patients were submitted to individual myofunctional therapy with the speech therapist, once a week, by four weeks.The myofunctional therapy began with isometric maneuvers for muscular elongation on the non paralyzed side, and on the paralyzed side when microsurgical reconstruction was present. It also included isotonic maneuvers to increase muscle tonus and isokinetic maneuvers to increase force on the paralyzed side.

Arms

Assigned Interventions

Active Comparator: A: myofunctional prior to botulinum

All the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group A, botulinum toxin was applied after myofunctional therapy.

Drug: Botulinum Toxin Type A

All the patients received a one-time treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol,the total dose used per patient ranged from 15-69U, mean 37.9±5.4U.

Other Name: BOTOX (Allergan)

Procedure: myofunctional therapy

All the patients were submitted to individual myofunctional therapy with the speech therapist, once a week, by four weeks.The myofunctional therapy began with isometric maneuvers for muscular elongation on the non paralyzed side, and on the paralyzed side when microsurgical reconstruction was present. It also included isotonic maneuvers to increase muscle tonus and isokinetic maneuvers to increase force on the paralyzed side.

Active Comparator: B: myofunctional after botulinum

All the facial paralysis patients received treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol. To the participants of Group B, botulinum toxin was applied before myofunctional therapy.

Drug: Botulinum Toxin Type A

All the patients received a one-time treatment with botulinum toxin type A to the non-paralyzed side, according to the Institution Protocol,the total dose used per patient ranged from 15-69U, mean 37.9±5.4U.

Other Name: BOTOX (Allergan)

Procedure: myofunctional therapy

All the patients were submitted to individual myofunctional therapy with the speech therapist, once a week, by four weeks.The myofunctional therapy began with isometric maneuvers for muscular elongation on the non paralyzed side, and on the paralyzed side when microsurgical reconstruction was present. It also included isotonic maneuvers to increase muscle tonus and isokinetic maneuvers to increase force on the paralyzed side.

Detailed Description:

Twenty-five patients with long standing facial palsy were studied; all had been previously treated for facial reanimation. Patients were randomly divided in two groups; Group A did the myofunctional therapy sessions with the speech therapist before the botulinum toxin injection, while the participants of Group B did the myofunctional therapy after it.

Eligibility


Ages Eligible for Study:	16 Years to 62 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

facial paralysis with more than 2 years elapsed since the onset of symptoms
surgically treated for reanimation at least 12 months before
static and/or dynamic facial asymmetry causing aesthetic concern

Exclusion Criteria:

spastic paralysis
serious systemic or neuromuscular diseases
cognition impairment
pregnant women

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989209

Locations


Brazil
University of Sao Paulo General Hospital
Sao Paulo, SP, Brazil, 05403-000

Sponsors and Collaborators

University of Sao Paulo General Hospital

Investigators


Study Director:	Alessandra G Salles	University of Sao Paulo General Hospital
Study Chair:	Marcus C Ferreira	University of Sao Paulo General Hospital
Principal Investigator:	Paula N Toledo	University of Sao Paulo General Hospital
Study Director:	Claudia F Andrade	University of Sao Paulo General Hospital

More Information

Publications:

Salles AG, Toledo PN, Ferreira MC. Botulinum toxin injection in long-standing facial paralysis patients: improvement of facial symmetry observed up to 6 months. Aesthetic Plast Surg. 2009 Jul;33(4):582-90. doi: 10.1007/s00266-009-9337-9. Epub 2009 Mar 28.


Responsible Party:	Paula Nunes Toledo, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:	NCT00989209 History of Changes
Other Study ID Numbers:	CAPPesq 890/04
Study First Received:	October 2, 2009
Last Updated:	October 2, 2009
Health Authority:	Brazil: Ministry of Health Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo General Hospital:


facial paralysis asymmetry myofunctional therapy botulinum toxin facial evaluation

Additional relevant MeSH terms:


Bell Palsy Facial Paralysis Paralysis Cranial Nerve Diseases DNA Virus Infections Facial Nerve Diseases Herpesviridae Infections Mouth Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms	Stomatognathic Diseases Virus Diseases Botulinum Toxins Botulinum Toxins, Type A Anti-Dyskinesia Agents Central Nervous System Agents Neuromuscular Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015