ANAISATM: Effectiveness of Cervical Treatment in Wind Musicians With Temporomandibular Dysfunction

Sponsor
Universidad de Murcia (Other)
Overall Status
Completed
CT.gov ID
NCT05893251
Collaborator
(none)
30
1
2
7
4.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Manual therapy
  • Other: Postural exercises
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The present study is an experimental, analytical, longitudinal, and prospective controlled randomized clinical trial.The present study is an experimental, analytical, longitudinal, and prospective controlled randomized clinical trial.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Using the "Random Team Generator" mobile application.
Primary Purpose:
Treatment
Official Title:
Effectiveness of Cervical Treatment in Wind Musicians With Temporomandibular Dysfunction
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Apr 1, 2018
Actual Study Completion Date :
Jun 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Protocol group

The treatment plan includes active postural exercises for the cervical spine.

Other: Postural exercises
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.

Other: Manual therapy
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

Outcome Measures

Primary Outcome Measures

  1. Cranio facial pain and disability inventory [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.

Secondary Outcome Measures

  1. Maximum mouth opening. [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.

Other Outcome Measures

  1. Pain pressure threshold in myofascial trigger points of the masticatory muscles. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Of Murcia Murcia Spain 30120

Sponsors and Collaborators

  • Universidad de Murcia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universidad de Murcia
ClinicalTrials.gov Identifier:
NCT05893251
Other Study ID Numbers:
  • ANAISATM
  • ANAISATM
First Posted:
Jun 7, 2023
Last Update Posted:
Jun 12, 2023
Last Verified:
Mar 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Universidad de Murcia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 12, 2023