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

Primary Purpose

Temporomandibular Joint Dysfunction Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual therapy
Postural exercises
Sponsored by
Universidad de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Dysfunction Syndrome focused on measuring TEMPOROMANDIBULAR JOINT, Cervical Posture, wind Musician

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Of Murcia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Protocol group

Manual therapy group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cranio facial pain and disability inventory
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

Maximum mouth opening.
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.

Full Information

First Posted
May 29, 2023
Last Updated
June 8, 2023
Sponsor
Universidad de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT05893251
Brief Title
Effectiveness of Cervical Treatment in Wind Musicians With Temporomandibular Dysfunction
Acronym
ANAISATM
Official Title
Effectiveness of Cervical Treatment in Wind Musicians With Temporomandibular Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Dysfunction Syndrome
Keywords
TEMPOROMANDIBULAR JOINT, Cervical Posture, wind Musician

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The present study is an experimental, analytical, longitudinal, and prospective controlled randomized clinical trial.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Using the "Random Team Generator" mobile application.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protocol group
Arm Type
Active Comparator
Arm Description
The treatment plan includes active postural exercises for the cervical spine.
Arm Title
Manual therapy group
Arm Type
Experimental
Arm Description
The treatment plan includes active postural exercises and manual therapy for the cervical spine.
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Postural exercises
Intervention Description
The treatment plan includes active postural exercises for the cervical spine.
Primary Outcome Measure Information:
Title
Cranio facial pain and disability inventory
Description
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.
Time Frame
a week after treatment
Secondary Outcome Measure Information:
Title
Maximum mouth opening.
Description
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.
Time Frame
a week after treatment
Other Pre-specified Outcome Measures:
Title
Pain pressure threshold in myofascial trigger points of the masticatory muscles.
Description
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.
Time Frame
a week after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University Of Murcia
City
Murcia
ZIP/Postal Code
30120
Country
Spain

12. IPD Sharing Statement

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Effectiveness of Cervical Treatment in Wind Musicians With Temporomandibular Dysfunction

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