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

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

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Disorder
• Intervention / Treatment: Other: Osteopathic Manipulative Treatment; Other: Sham intervention

Detailed Description

Objective:

It is known the multifactorial etiology of Temporomandibular Disorders(TMD) which raises the need of a multidisciplinary approach for its treatment. Studies have presented good results about the use of occlusal splints along with other therapies. The Osteopathic Manipulative Treatment(OMT) has as characteristic the philosophy of global approach and precise functional diagnosis. Based on a lack of randomized blind trials about this subject, This study aim to contribute with the investigation of the therapeutic effect OMT in pain intensity and Quality of Life in participants diagnosed with TMD making use of occlusal splints.

Methodology:

This study is a randomized blind trial, with sample composed by 18 participants referred to the occlusion clinic of Fluminense Federal University (UFF), diagnosed by the team of dentists and interns of occlusion clinic through the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). The participants will complete the Short Form 36 Health Survey(SF-36) to measure the quality of life, and pain intensity diagram with Numeric Rating Scale (NRS) to measure the pain intensity. The sample will be randomized into 2 groups (9 individuals for each): Test Group (TG) - patients subject to Clinical Treatment with splints (CT) offered at the Occlusion Clinic unit along with Osteopathic Manipulative Treatment - OMT. Control Group (CG) - patients subject only to CT and will receive a sham treatment that simulate the OMT to blind these participants. After the treatment, patients will be re-evaluated in 8 weeks' time.

Statistical analysis:

The SF-36 and the pain intensity and the most intense pain evaluation diagram with Numeric Rating Scale (NRS) will be performed by the Wilcoxon's non parametric test.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Niteroi, RJ, Brazil, 24020-140
      • Federal Fuminense University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• individuals who has diagnosis of Temporomandibular disorder.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group (TG); 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; 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;
Sham Comparator: Control Group (CG); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Numeric Rating Scale (NRS) for the body area with the Worst Pain(WP) at 2 months	The use of Numeric Rating Scale (NRS) to measure de pain intensity in the body area with the most intensity pain related by the individuals before and 2 months after first intervention.	2 months
Change from Quality of Life Survey by Short Form 36 Health Survey(SF-36) at 2 months	The use of SF36 to measure the score of quality of life before and 2 months after first intervention.	2 months

Collaborators and Investigators

• Sponsor: Universidade Federal Fluminense
• Investigators: Principal Investigator: Felipe RT Goulart, Graduated, Federal Fluminense University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Osteopathic Manipulative Treatment; Temporomandibular Disorder
• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Disease; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: Simone Oliveira

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided