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

NCT02974166 | Completed DMC

• 1 other identifier: InstitutoBOsteopatia
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorder

Keywords

Temporomandibular Disorder; Osteopathic Manipulative Treatment; Rigid Splint; Speech Therapy

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain assessed by visual analogue scale.

  4 weeks

Secondary Outcomes (1)

• (RDC/ TMD) Research Diagnostic Criteria for Temporomandibular Disorders

  4 weeks

Study Arms (2)

Conventional Group

ACTIVE COMPARATOR

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; Drug: Ibuprofen; Drug: Cyclobenzaprine Hydrochloride

Osteopathic Group

EXPERIMENTAL

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; Drug: Ibuprofen; Drug: Cyclobenzaprine Hydrochloride

Interventions

Conventional Group 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.

Conventional Group

Osteopathic Group 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.

Osteopathic Group

Ibuprofen DRUG

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

Also known as: anti-inflammatory drug

Conventional Group; Osteopathic Group

Cyclobenzaprine Hydrochloride DRUG

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

Also known as: muscle relaxer

Conventional Group; Osteopathic Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Brasileiro de Osteopatia: lead

Study Sites (1)

Brazilian Institute of Osteopathy

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Communication Disorders

Interventions

Ibuprofen; Anti-Inflammatory Agents; cyclobenzaprine

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Thiago B Susin

  IBO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, DO

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 28, 2016
• Study Start: March 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: August 1, 2016
• Last Updated: November 28, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)