Osteopathic Manipulative Treatment in Individuals With Temporomandibular Disorder Who Make Use of Occlusal Splints

NCT02991326 | Completed

• 1 other identifier: Simone Oliveira
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This study aim to contribute with the investigation of the therapeutic effect of osteopathic manipulative treatment in pain intensity and Quality of Life in individuals diagnosed with temporomandibular disorder who make use of occlusal splints.

Conditions

Temporomandibular Disorder

Keywords

Osteopathic Manipulative Treatment; Temporomandibular Disorder

Outcome Measures

Primary Outcomes (1)

• Change from Numeric Rating Scale (NRS) to measure the pain intensity at 2 month

  The use of Numeric Rating Scale (NRS) to measure the pain intensity in each body area related by the individuals before and 2 months after the first intervention.

  2 months

Secondary Outcomes (2)

• Change from Numeric Rating Scale (NRS) for the body area with the Worst Pain(WP) at 2 months

  2 months

• Change from Quality of Life Survey by Short Form 36 Health Survey(SF-36) at 2 months

  2 months

Study Arms (2)

Test Group (TG)

EXPERIMENTAL

The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to Osteopathic Manipulative Treatment - OMT.

Other: Osteopathic Manipulative Treatment

Control Group (CG)

SHAM COMPARATOR

The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to sham intervention (Osteopathic Manipulative Treatment simulated).

Other: Sham intervention

Interventions

Osteopathic Manipulative Treatment OTHER

The Osteopathic manipulative treatment will follow the approach bellow (using latex gloves for intra oral techniques): * Compression of the fourth ventricle; * inhibitory intra-oral pressure technique (IPT) of the temporal muscle; * inhibition of the inferior head of the lateral pterygoid muscle; * intra-oral inhibition of the masseter muscle; * Balanced ligamentous tension (BLT) of the accessory ligaments - sphenopalatine; * BLT of the accessory ligaments - pterygomandibular raphe; * sphenopalatine ganglion technique; * Craniosacral rebalancing;

Test Group (TG)

Sham intervention OTHER

The sham intervention will be made in the same examination table and the same position, with the use of the latex gloves, to simulate the Osteopathic Manipulative Treatment, only doing simple touches without therapeutic effect intention.

Control Group (CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals who has diagnosis of Temporomandibular disorder.

You may not qualify if:

• individuals who already has subjected to osteopathic manipulative treatment to temporomandibular disorder.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Federal Fuminense University

Niterói, Rio de Janeiro, 24020-140, Brazil

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Felipe RT Goulart, Graduated

  Federal Fluminense University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 13, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: May 1, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-05

Locations

BR (1)