NCT04977349

Brief Summary

Orofacial pain is one of the most common dysfunctions among wind musicians, a population with a high incidence of temporomandibular disorder (TMD). Regarding the treatment of TMD, the efficacy of manual therapy and therapeutic exercise has been studied, but there is a lack of high quality research supporting its implementation. There is, however, an agreement on the need of combining the treatment of the temporomandibular joint and the cervical spine, due to their close biomechanical relation. Aims of the study: To analyse the efficacy of an evidence-based manual therapy protocol alone or in combination with an exercise program on the treatment of orofacial pain during musical practice on wind musicians. Furthermore, this study aims at observing whether if said treatment is more effective in the short, medium, or long term, and which variables are the most influenced.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

December 1, 2020

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4.4 years

First QC Date

December 1, 2020

Last Update Submit

April 27, 2026

Conditions

Keywords

Orofacial painWind musiciansManual TherapyExercise program

Outcome Measures

Primary Outcomes (4)

  • Orofacial pain

    Visual Analogic Scale.The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations. The VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured from 0 (no pain) to 10 (maximum pain). All the subjects will showed their pain level.

    Change from baseline at 2 months

  • Pressure Pain Threshold

    An algometer Wagner FPI 10-WA will be used to determine the Pressure Pain Threshold in trigger points.

    Change from baseline at 2 months

  • Range of Temporo mandibular Movement

    A vernier caliper will be used to measure mandibular movements. A vernier caliper is a validated tool to measure the opening, protusion, laterotrusion and overjet movements of the temporo mandibular joint

    Change from baseline at 2 months

  • cervical range of movement (CROM)

    The instruments used to assess CROM will be a CROM goniometer. The CROM goniometer is a validated tool to measure the flexion, extension, rotation and tilt movements of the cervical spine.

    Change from baseline at 2 months

Study Arms (2)

Wind Musicians

EXPERIMENTAL

Isometric exercises for: cranial protrusion, mouth opening, laterality cervical movement and cervical coordination by laser assesment. And the manual therapy from the Active Comparator group.

Other: Manual TherapyOther: Exercise program

Wind musicians

ACTIVE COMPARATOR

This group will be treated by manual therapy: suboccipital inhibition, myofascial extracavitary treatment in (superior trapezius fibers, Sternocleidomastoid (ECOM), masseter and temporalis) and intracavitary muscles (medialis and lateral pterygoid muscles).

Other: Manual TherapyOther: Exercise program

Interventions

This group will be treated by manual therapy: suboccipital inhibition, myofascial extracavitary treatment in (superior trapezius fibers, ECOM, masseter and temporalis) and intracavitary muscles (medialis and lateral pterygoid muscles).

Wind MusiciansWind musicians

Isometric exercises for: cranial protrusion, mouth opening, laterality cervical movement and cervical coordination by laser assessment. And the manual therapy from the Active Comparator group.

Wind MusiciansWind musicians

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metal or wood wind musicians
  • Orofacial pain during the practice in the last 30 days.
  • More than 20 hours by week in the practice.
  • Between 18-65 years old.

You may not qualify if:

  • Neurological diseases.
  • Analgesics previous treatments.
  • Any trauma or bone fractures in skull or cervical spine.
  • Any surgical intervention in cervical spine, orofacial region or temporo-mandibular joint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Overall Study Officials

Alcalá de Henares, Madrid, 28807, Spain

Location

Nursing and Physiotherapy Faculty

Alcalá de Henares, Madrid, 28871, Spain

Location

MeSH Terms

Conditions

Facial Pain

Interventions

Musculoskeletal ManipulationsResistance Training

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationExercise TherapyAftercareContinuity of Patient CarePatient CarePhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice-dean of Physiotherapy

Study Record Dates

First Submitted

December 1, 2020

First Posted

July 26, 2021

Study Start

September 1, 2021

Primary Completion

February 10, 2026

Study Completion

April 10, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations