Manual Therapy Effectivity and Exercises in Musicians

Manual Therapy Effectivity Combinated or Lonely With an Exercises Program for a Wind Musicians With Orofacial Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Orofacial Pain
• Intervention / Treatment: Other: Manual Therapy; Other: Exercise program

Detailed Description

Methods: A sample of 40 wind musicians with orofacial pain during practice with the instrument will be recruited in the different conservatories of the Community of Madrid. The sample will be divided into two different groups: a control group who will receive the manual therapy protocol, and an experimental group who will, in addition, receive an exercise program. Treatment will consist of ten session distributed along 5 weeks, of an approximated duration of 30 minutes per session. Assessments will be carried out pre- and post-intervention, and for a two- and four-months follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia M Merinero, PhD; Phone Number: 661637862; Email: patricia.m.merinero@gmail.com

Study Locations

• Spain
  • Madrid
    • Alcalá De Henares, Madrid, Spain, 28871
      • Not yet recruiting
      • Nursing and Physiotherapy Faculty
      • Contact: Samuel Fernandez-Carnero, PhD; Phone Number: +34620895315; Email: samuel.fernandezc@uah.es
      • Contact: Daniel Pecos-Martin, PhD; Phone Number: +34630909495; Email: daniel.pecos@uah.es
    • Alcalá de Henares, Madrid, Spain, 28807
      • Recruiting
      • Overall Study Officials
      • Contact: Laura López-García; Phone Number: +34 918855142; Email: gifyd@uah.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wind Musicians; 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 Therapy; 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).; Other: Exercise program; 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.
Active Comparator: Wind musicians; 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 Therapy; 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).; Other: Exercise program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Prof. Dr. Daniel Pecos Martín

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): May 10, 2024
• Study Completion (Estimated): June 10, 2024

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Exercise program; Manual Therapy; Orofacial pain; Wind musicians
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Facial Pain
• Other Study ID Numbers: CEIM/HU/2020/40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No