Effectiveness of Cervical Treatment in Wind Musicians With Temporomandibular Dysfunction (ANAISATM)

June 8, 2023 updated by: Universidad de Murcia

Temporomandibular dysfunction (TMD) consists of a series of multifactorial signs and symptoms that occur in the orofacial region, with pain being the most common symptom. There is a close biomechanical and anatomical relationship between the cervical region and the temporomandibular joint (TMJ) through the trigemino-spinal nucleus.

Objectives: To comparatively assess the improvement in subjects with TMD when adding cervical manual therapy to a postural treatment. Additionally, to determine if both cervical treatments separately produce changes in the TMJ.

Materials and methods: An experimental study of randomized controlled clinical trial type was conducted. The study involved 30 wind instrument players randomly assigned to an experimental group (EG) and a control group (CG). After obtaining consent, measurements were taken for maximum mouth opening (MMO), cervical range of motion, and pain threshold to pressure (PTP) in the masseter and temporalis muscles. Both groups underwent active cervical postural treatment for 4 weeks, and the EG additionally received a cervical manual therapy protocol. An initial assessment was conducted before the intervention, and a final assessment was done one week after the last intervention. The statistical program SPSS was used for data analysis.

Study Overview

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Murcia, Spain, 30120
        • University of Murcia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Acceptance of written informed consent.
  • Playing a wind instrument.
  • Age between 18-40 years.
  • Pain in the cranio-cervico-mandibular region and/or masticatory muscles.
  • Hypertrophy in the masticatory muscles.

Exclusion Criteria:

  • History of trauma and/or fracture in the cranial and/or facial region.
  • Rheumatic injury or degenerative disease.
  • Surgical intervention on the temporomandibular joint (TMJ).
  • Malformations of the cervical or cranial spine.
  • Vestibular, circulatory, or neurological disorders.
  • Degenerative or infectious joint diseases.
  • Current orthodontic treatment.
  • Receiving physiotherapy treatment during the two weeks prior to the study or during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Protocol group
The treatment plan includes active postural exercises for the cervical spine.
The treatment plan includes active postural exercises for the cervical spine.
Experimental: Manual therapy group
The treatment plan includes active postural exercises and manual therapy for the cervical spine.

Within the manual therapy protocol carried out in the experimental group, we performed a series of passive maneuvers. The patient remains in supine position on a treatment table throughout the treatment, while the therapist sits at the head of the patient on a stool. The sequence of application is as follows:

Suboccipital inhibition technique Cervical spinal mobilization Posterior fascia stretching

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cranio facial pain and disability inventory
Time Frame: a week after treatment
CF-PDI (Craniofacial Pain and Disability Inventory): This questionnaire focuses on pain as a common symptom of TMD (Temporomandibular Disorders). It is self-administered and designed to assess patients' perception of their physical and psychosocial health in relation to craniofacial pain. It consists of 21 questions regarding the impact of pain on activities involving the use of the temporomandibular joint, with a scoring range from 0 to 63 in ascending order, where 0 indicates no impact and 63 indicates maximum impact. This questionnaire demonstrates good structure, internal consistency, reproducibility, and validity, making it an objective tool that can be used in research and clinical practice for evaluating patients with craniofacial pain and disability. It is easy to administer and requires a short amount of time. The CF-PDI was created and developed in Spain, based on a biopsychosocial approach.
a week after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum mouth opening.
Time Frame: a week after treatment
The measurement of maximum mouth opening (MMO) is the distance in centimeters between the upper and lower incisor teeth when the subject actively opens their mouth.
a week after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain pressure threshold in myofascial trigger points of the masticatory muscles.
Time Frame: a week after treatment
In TMD, myofascial pain of the masticatory muscles is the most relevant clinical entity that affects the masticatory system. It will be measured using a pressure algometer.
a week after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

May 29, 2023

First Submitted That Met QC Criteria

May 29, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

March 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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