Clinical trial NCT04098952: Effects of Electric Massage on the Cervical Region in Subjects Diagnosed With Temporomandibular Disorders
Official title: Effects of Electric Massage on the Cervical Region Combined With Local Techniques on the Temporomandibular Joint Versus an Intervention Only With Local Techniques in Subjects Diagnosed With Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorders
Keywords: temporomandibular disorders
electric massage
temporomandibular joint
local techniques
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To know the short-term effects of electric massage applied on the cervical region combined with local techniques on the temporomandibular joint versus an intervention that applies only local techniques in subjects diagnosed with temporomandibular disorders.

Detailed description: This study aims to know the short-term effects of electric massage applied to the cervical region combined with local techniques on the temporomandibular pain versus an intervention that applies only local techniques in subjects diagnosed with temporomandibular disorders. This is a prospective, controlled, single-blind clinical trial of 46 subjects randomly divided into two groups: Group 1 Manual Therapy=21; Group 2 Interferential massage plus Manual Therapy=25. Group 1 will receive manual therapy consisting of techniques of ischemic compression on masseter muscles and soft-tissue release technique over the temporal región. Group 2, in addition to the intervention in group 1, will receive electric massage with interferential currents at the cervical level.

Pain related measures (Visual Analogue Scale oral, Pressure Pain Threshold (PPT)), vertical mouth opening as primary outcome measures and cervical range of motion as secondary outcomes were assessed. The assessments were made before the intervention, immediately after and after 4 weeks of follow-up.

Eligibility criteria: Inclusion Criteria:

* Consent of the subject to participate in the study.
* A primary diagnosis of myofascial pain according to Axis I, category Ia and Ib (i.e. myofascial pain with or without limited opening) of the Research Diagnostic Criteria for TMD (RDC ⁄ TMD) (Schiffman E, Ohrbach R, Truelove E, et al. Diagnostic criteria for tempormandibular disorders (DC(TMD) for clinical and research applications: recommendations of the International RDC/TMD consortium network\* and orofacial pain special interest group. J Oral facial pain headache. 2014;28(1):6-27").
* Bilateral pain involving the masseter and temporal regions; presence of at least one trigger point (TrP) in the masseter muscle.
* Pain symptoms history of at least the 3 months previous to the study.
* Intensity of the pain of at least 30 mm on a 100 mm Visual Analogue Scale (VAS).
* A score of less than 45 points on the Personal Psychological Apprehension Scale (PPAS). It has been validated in the scope of physiotherapy, and represents a simple-to-handle tool in studies where subjects may undergo electrotherapy as a treatment option.

Exclusion Criteria:

* Surgical intervention of the temporomandibular joints (TMJ).
* Suffering some intra-articular damage (arthritis) or some vestibular disorder diagnosed.
* Inflammation of the TMJ.
* Having received physiotherapy treatment in the last two weeks.
* Receive pharmacological treatment for analgesic, anti-inflammatory or that could cause alterations of equilibrium.

Primary outcomes:
measure: Changes in the assessment of the maximum amplitude of the vertical opening of the mouth:
timeFrame: Immediately after the intervention as well as 4 weeks after the intervention.
measure: Changes in the assessment of pain intensity: VAS
timeFrame: Immediately after the intervention as well as 4 weeks after the intervention.
measure: Changes in the valuation of pain threshold to pressure.
timeFrame: Immediately after the intervention as well as 4 weeks after the intervention.
Secondary outcomes:
measure: Changes in the assessment of cervical range of motion.
timeFrame: Immediately after the intervention as well as 4 weeks after the intervention.
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Luis Espejo Antúnez
Study officials:
affiliation: Department of Medical Surgical Therapy.
name: Luis Espejo Antúnez, PhD
role: STUDY_DIRECTOR
References: