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Clinical Trial Summary

Objective: To evaluate the efficacy of a manual therapy protocol composed of articulatory and myofascial techniques in patients with temporomandibular dysfunction (TMD).

Methods: Randomized and controlled clinical study of patients presenting TMD. The subjects will be divided into 2 groups: 1) manual therapy group; 2) control group. There will be 4 treatment sessions during 4 weeks, with evaluations before and after the study, which include: severity of dysfunction (Helkimo Index), quality of life (Short Form 36 Health Survey), pressure pain threshold (algometer) ), cervical mobility (goniometer), mouth opening (caliper), pain intensity (Visual Analogue Scale) and cervical disability (Neck Disability Index).


Clinical Trial Description

Introduction. Temporomandibular dysfunction (TMD) is the set of clinical manifestations that affect this joint, the masticatory muscles and the structures associated with and involved in TMJ movements. This dysfunction represents a subclassification of musculoskeletal disorders, and presents with different symptoms and signs that include pain in the jaw joint or in the tissues that surround it, generalized myofascial pain, crackling or crackling joint noise associated with the movement, decrease in joint range, functional limitation, and deviation to the opening of the jaw.

Objective. The main objective of this study is to compare the efficacy of a myofascial soft tissue treatment versus a control group in people diagnosed with TMD of myofascial origin.

Material and methods

Sample. Subjects with dagnosis of TMD according to the diagnostic criteria for the investigation of temporomandibular disorders.

Study design. Randomized clinical trial with 2 groups: Group 1. Manual therapy protocol of SOFT TISSUES; Group 2. Regular treatment control.

Evaluations. Clinical interview with anthropometric data and characteristics of the pathology.

There will be 3 evaluations: at the beginning of the study, at the end of the treatment (at 4 weeks) and at 8 weeks as part of the follow-up period.

In addition, it includes the following evaluation instruments:

- Visual Analog Scale (EVA)

- Algometry of the masseter, temporal and ECOM muscles.

- Oral opening range.

- Range of cervical joint movement.

- Quality of life questionnaire related to oral health OHIP-14.

- Quality of life questionnaire SF-36.

- Index of clinical dysfunction of Helkimo.

- Cervical disability index. ;


Study Design


Related Conditions & MeSH terms

  • Temporomandibular Dysfunction (TMD)
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome

NCT number NCT03555201
Study type Interventional
Source University of Valencia
Contact
Status Completed
Phase N/A
Start date May 31, 2018
Completion date August 15, 2018

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