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

NCT ID: NCT02974166

Last Updated: 2016-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Temporomandibular Disorder

Keywords

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Temporomandibular Disorder Osteopathic Manipulative Treatment Rigid Splint Speech Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Conventional Group

Intervention Type OTHER

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.

Ibuprofen

Intervention Type DRUG

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

Cyclobenzaprine Hydrochloride

Intervention Type DRUG

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

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).

Group Type EXPERIMENTAL

Osteopathic Group

Intervention Type OTHER

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.

Ibuprofen

Intervention Type DRUG

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

Cyclobenzaprine Hydrochloride

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Ibuprofen

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

Intervention Type DRUG

Cyclobenzaprine Hydrochloride

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

Intervention Type DRUG

Other Intervention Names

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anti-inflammatory drug muscle relaxer

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Brasileiro de Osteopatia

OTHER

Sponsor Role lead

Responsible Party

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Thiago Boeira Susin, PT, DO

PT, DO

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thiago B Susin

Role: PRINCIPAL_INVESTIGATOR

IBO

Locations

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Brazilian Institute of Osteopathy

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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InstitutoBOsteopatia

Identifier Type: -

Identifier Source: org_study_id