Clinical trial NCT03555201: Efficacy of Physiotherapy in Patients With Temporomandibular Disorders.
Official title: Efficacy of a Physiotherapy Protocol Based on Manual Therapy in Patients With Temporomandibular Disorders.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Dysfunction (TMD)
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patients with TMD or myofascial pain according to the Helkimo index.
* Use of the discharge splint, except in the 2 weeks prior to the study.
* Age of the subjects between 18 and 65 years old.
* Presence of TMD signs and symptoms in the 3 months prior to the study, such as limitations in movements, pain and / or deviation during opening of the mouth, muscular sensitivity, and sounds produced by the joint during opening of the mouth.
* Limitation of active vertical opening of the mouth \<40 mm.
* Bilateral pain that surrounds the areas of the temporal and the masseter.
* Presence of at least one trigger point in the masseter and temporal muscles.
* Patients who sign the informed consent.

Exclusion Criteria:

* That they did not use the splint, except in the 2 weeks prior to the study.
* Presence of systemic, rheumatic or central nervous system diseases.
* Trauma or previous surgical intervention in the ATM region.
* History of some type of treatment (physiotherapy or acupuncture) in the 3 months prior to the study.
* Use of analgesics or muscle relaxants at least 24 hours before the evaluations and during the treatment period.
* Presence of another type of orofacial pain disorder.
* Presence of signs or symptoms of disc displacement, osteoarthritis or TMJ arthritis.
* Positive extension-rotation test (vertebral artery test or Klein test) or cerebrovascular changes.

Primary outcomes:
measure: Intensity of pain
timeFrame: 8 weeks
Secondary outcomes:
measure: Severity and degree of dysfunction
timeFrame: 8 weeks
measure: Health status
timeFrame: 8 weeks
measure: Cervical disability
timeFrame: 8 weeks
measure: Opening range of the mouth
timeFrame: 8 weeks
measure: Pressure pain threshold
timeFrame: 8 weeks
measure: Cervical mobility
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Faculty of Physiotherapy
Study officials:
References: