NCT05893251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
Last Updated

June 12, 2023

Status Verified

March 1, 2018

Enrollment Period

5 months

First QC Date

May 29, 2023

Last Update Submit

June 8, 2023

Conditions

Keywords

TEMPOROMANDIBULAR JOINTCervical Posturewind Musician

Outcome Measures

Primary Outcomes (1)

  • 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.

    a week after treatment

Secondary Outcomes (1)

  • Maximum mouth opening.

    a week after treatment

Other Outcomes (1)

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

    a week after treatment

Study Arms (2)

Protocol group

ACTIVE COMPARATOR

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

Other: Postural exercises

Manual therapy group

EXPERIMENTAL

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

Other: Manual therapy

Interventions

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

Manual therapy group

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

Protocol group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Murcia

Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Temporomandibular Joint DisordersCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesMyofascial Pain SyndromesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Using the "Random Team Generator" mobile application.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The present study is an experimental, analytical, longitudinal, and prospective controlled randomized clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2023

First Posted

June 7, 2023

Study Start

November 1, 2017

Primary Completion

April 1, 2018

Study Completion

June 1, 2018

Last Updated

June 12, 2023

Record last verified: 2018-03

Locations