Effects of Electric Massage on the Cervical Region in Subjects Diagnosed With Temporomandibular Disorders

NCT04098952 | Completed

• 1 other identifier: LE0001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorders

Keywords

temporomandibular disorders; electric massage; temporomandibular joint; local techniques

Outcome Measures

Primary Outcomes (3)

• Changes in the assessment of the maximum amplitude of the vertical opening of the mouth:

  The maximum vertical opening of the mouth was measured using a manual gauge. The measurements were taken with the subjects placed in the supine position on the stretcher, with the head resting on it, the cervical spine in a neutral position, knees slightly bent and the upper limbs extended along the body. In this position, we ask participants to open their mouths as much as possible without causing pain. In this way, we obtain the measurement in millimeters the distance between the upper and lower central incisors.

  Immediately after the intervention as well as 4 weeks after the intervention.

• Changes in the assessment of pain intensity: VAS

  To measure pain, the visual analog scale (VAS) has been used. The VAS scale is an instrument used very often to quantify the intensity of pain. The accuracy and validity of the EVA scale as a measure of pain has been demonstrated previously. Participants were asked to indicate the degree of pain intensity in response to manual palpation of the central trigger point of the masseter bilaterally using a 10 cm analogue visual scale where 0 corresponds to "no pain" and 10 to "worst pain" that you can imagine. " When performing the post-treatment assessment, a period of 1 minute of rest was left to prevent the change of position from influencing the data obtained, especially in the displacements of the pressure center.

  Immediately after the intervention as well as 4 weeks after the intervention.

• Changes in the valuation of pain threshold to pressure.

  To measure the pain threshold to the pressure in muscle trigger points, a manual algometer with 1 cm2 of contact area was used. The algometer serves to record the minimum amount of pressure needed for the sensation of pressure to change to a sensation of pain. When this moment arrives, the subject will say "already" and the algometer immediately withdrawn, the pressure being recorded. The results obtained will be expressed in kg / cm2 (1,8). The muscles assessed were masseter and superior trapezius, both bilaterally in the supine position. The pressure in both must be done in a direction perpendicular to the muscle fibers. In the case of the upper trapezius, the algometer will be placed on the trigger point 1 described by Travell and Simons (9). In the masseter, the pressure perpendicular to the algometer will be applied on the central trigger point of the superficial portion of said muscle as described by Travell.

  Immediately after the intervention as well as 4 weeks after the intervention.

Secondary Outcomes (1)

• Changes in the assessment of cervical range of motion.

  Immediately after the intervention as well as 4 weeks after the intervention.

Study Arms (2)

Group 1: Manual Therapy

ACTIVE COMPARATOR

The treatment techniques used will be: ischemic compression in the trigger point of the masseter and soft-tissue release technique over the temporal region.

Other: Group 1: Manual Therapy

Group 2: Interferential massage plus Manual Therapy

EXPERIMENTAL

In addition to the treatment techniques applied to the other group, an electric massage will be performed with interferential currents at the level of the cervical region.

Other: Group 2: Interferential massage plus Manual Therapy

Interventions

Group 1: Manual Therapy OTHER

The treatment techniques used will be: ischemic compression in the trigger point of the masseter and soft-tissue release technique over the temporal region.

Group 1: Manual Therapy

Group 2: Interferential massage plus Manual Therapy OTHER

In addition to the treatment techniques applied to the other group, an electric massage will be performed with interferential currents at the level of the cervical region.

Group 2: Interferential massage plus Manual Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luis Espejo Antúnez PhD: lead

Study Sites (1)

Luis Espejo Antúnez

Badajoz, 06006, Spain

Location

Related Publications (1)

• Espejo-Antunez L, Cardero-Duran MLA, Heredia-Rizo AM, Casuso-Holgado MJ, Albornoz-Cabello M. Effects of adding electro-massage to manual therapy for the treatment of individuals with myofascial temporomandibular pain: a randomized controlled trial. J Appl Oral Sci. 2024 Sep 16;32:e20240109. doi: 10.1590/1678-7757-2024-0109. eCollection 2024.

  PMID: 39292112 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Luis Espejo Antúnez, PhD

  Department of Medical Surgical Therapy.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Medical Surgical Therapy.

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: September 23, 2019
• Study Start: November 18, 2019
• Primary Completion: November 18, 2019
• Study Completion: October 14, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

ES (1)