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

Temporomandibular Disorder Clinical Trial

Official title:

Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974166
• Other study ID #: InstitutoBOsteopatia
• Status: Completed
• Phase: N/A
• First received: November 16, 2016
• Last updated: November 22, 2016
• Start date: March 2012
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Instituto Brasileiro de Osteopatia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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

Locations

Country	Name	City	State
Brazil	Brazilian Institute of Osteopathy	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Brasileiro de Osteopatia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain assessed by visual analogue scale.	4 weeks	No
Secondary	(RDC/ TMD) Research Diagnostic Criteria for Temporomandibular Disorders		4 weeks	No