Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders

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ClinicalTrials.gov Identifier: NCT02974166

Recruitment Status : Completed

First Posted : November 28, 2016

Last Update Posted : November 28, 2016

Sponsor:

Information provided by (Responsible Party):

Thiago Boeira Susin, PT, DO, Instituto Brasileiro de Osteopatia

Study Description

Brief Summary:

The purpose of this study is to determine whether osteopathic manipulative treatment associated to Dentistry care and speech therapy improves pain and function in individuals with temporomandibular disorders.

Condition or disease	Intervention/treatment	Phase
Temporomandibular Disorder	Other: Conventional Group Other: Osteopathic Group Drug: Ibuprofen Drug: Cyclobenzaprine Hydrochloride	Not Applicable

Detailed Description:

A standardized TMD examination was executed in all patients by a dentist following the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/ TMD) questionnaire, Axis I and II, portuguese version. The RDC/ TMD is compound by a 31 items questionnaire and a ten items clinical exam. All these items are related to patients symptoms and signs; to mandibular functional impairment; and social-demographics, social-economics, psychological e psychosocial data. The first part as Axis I tend to clinical assess and classify the TMD and the second, as Axis II propose a chronic pain score that could quantify the psychosocial impairment and present a subjects profile.

Others assessment instruments utilized on the research were the VAS consists in a 10 cm horizontal line with "no pain" on the left side and "worst pain" on right side, then the subjects were instructed to vertical risk the level of pain. The digital caliper with a 0,03 mm precision was used to measure the maximal mouth opening (MMO) as the maximal inter-incisal vertical distance of the incisors. The subjects were seated at 90° with neutral head position and solicited to open their mouths the maximum they can unassisted and without pain, maximum unassisted opening and maximum assisted opening. Also, a portable digital pressure algometer for measuring sensitivity to pressure before it became painful. The masseters and temporalis muscles trigger point location were used as reference to guarantee the reproducibility of the proceeding as well as to assess the always the same site. The statistical analysis was performed using the means comparisons for the parametric tests through Student T test and for the non-parametrical data, Wilcoxon. Also, it was made the descriptive statistical with frequencies analysis.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	32 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
Official Title:	Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders: Randomized Clinical Trial
Study Start Date :	March 2012
Actual Primary Completion Date :	November 2015
Actual Study Completion Date :	August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Temporomandibular Joint Dysfunction

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Conventional Group Individuals with temporomandibular disorder were used rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions during four weeks.	Other: Conventional Group Rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) were made and prescribed under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions. Drug: Ibuprofen The medication was prescribed by the dentist as nonsteroidal anti-inflammatory drug if necessary. Other Name: anti-inflammatory drug Drug: Cyclobenzaprine Hydrochloride The medication was prescribed by the dentist as muscle relaxer if necessary. Other Name: muscle relaxer
Experimental: Osteopathic Group Individuals with temporomandibular disorder received the same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week until the end of dental and speech therapy treatments (4 weeks).	Other: Osteopathic Group Same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week during four weeks. The osteopathic treatment consisted in an individualized assessment of mobility restrictions of myofascial tissues and joints and the application of smooth techniques such myofascial release, membranous strain and counterstrain, muscle energy, cranial and high velocity and low amplitude. Drug: Ibuprofen The medication was prescribed by the dentist as nonsteroidal anti-inflammatory drug if necessary. Other Name: anti-inflammatory drug Drug: Cyclobenzaprine Hydrochloride The medication was prescribed by the dentist as muscle relaxer if necessary. Other Name: muscle relaxer

Arm

Intervention/treatment

Active Comparator: Conventional Group

Individuals with temporomandibular disorder were used rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions during four weeks.

Other: Conventional Group

Rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) were made and prescribed under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions.

Drug: Ibuprofen

The medication was prescribed by the dentist as nonsteroidal anti-inflammatory drug if necessary.

Other Name: anti-inflammatory drug

Drug: Cyclobenzaprine Hydrochloride

The medication was prescribed by the dentist as muscle relaxer if necessary.

Other Name: muscle relaxer

Experimental: Osteopathic Group

Individuals with temporomandibular disorder received the same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week until the end of dental and speech therapy treatments (4 weeks).

Other: Osteopathic Group

Same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week during four weeks. The osteopathic treatment consisted in an individualized assessment of mobility restrictions of myofascial tissues and joints and the application of smooth techniques such myofascial release, membranous strain and counterstrain, muscle energy, cranial and high velocity and low amplitude.

Drug: Ibuprofen

The medication was prescribed by the dentist as nonsteroidal anti-inflammatory drug if necessary.

Other Name: anti-inflammatory drug

Drug: Cyclobenzaprine Hydrochloride

The medication was prescribed by the dentist as muscle relaxer if necessary.

Other Name: muscle relaxer

Outcome Measures

Primary Outcome Measures :

Pain intensity [ Time Frame: 4 weeks ]
Pain assessed by visual analogue scale.

Secondary Outcome Measures :

(RDC/ TMD) Research Diagnostic Criteria for Temporomandibular Disorders [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

subjects of both genders with TMD diagnosed and minimum pain intensity of 40 mm on a visual analogue scale (VAS) who need dental treatment.

Exclusion Criteria:

continuous use of analgesic medication, mouth opening above 40 mm, presence of any other orofacial pain not related to TMD and being under orthodontic or TMD treatment.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974166

Locations

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Brazil
Brazilian Institute of Osteopathy
Porto Alegre, Rio Grande do Sul, Brazil

Sponsors and Collaborators

Instituto Brasileiro de Osteopatia

Investigators

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Principal Investigator:	Thiago B Susin	IBO

More Information

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Responsible Party:	Thiago Boeira Susin, PT, DO, PT, DO, Instituto Brasileiro de Osteopatia
ClinicalTrials.gov Identifier:	NCT02974166 History of Changes
Other Study ID Numbers:	InstitutoBOsteopatia
First Posted:	November 28, 2016 Key Record Dates
Last Update Posted:	November 28, 2016
Last Verified:	November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Thiago Boeira Susin, PT, DO, Instituto Brasileiro de Osteopatia:


Temporomandibular Disorder Osteopathic Manipulative Treatment Rigid Splint Speech Therapy

Additional relevant MeSH terms:

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Disease Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Pathologic Processes Craniomandibular Disorders Mandibular Diseases Jaw Diseases Musculoskeletal Diseases Joint Diseases Muscular Diseases Stomatognathic Diseases Myofascial Pain Syndromes Ibuprofen Amitriptyline Anti-Inflammatory Agents	Cyclobenzaprine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Muscle Relaxants, Central

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