Manual Therapy Effectivity and Exercises in Musicians

Orofacial Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04977349
• Other study ID #: CEIM/HU/2020/40
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: June 10, 2024

Study information

• Verified date: January 2024
• Source: University of Alcala
• Contact: Patricia M Merinero, PhD
• Phone: 661637862
• Email: patricia.m.merinero[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 10, 2024
• Est. primary completion date: May 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Facial Pain
• Orofacial Pain

Intervention

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).
• 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.

Locations

Country	Name	City	State
Spain	Nursing and Physiotherapy Faculty	Alcalá De Henares	Madrid
Spain	Overall Study Officials	Alcalá de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Daniel Pecos Martín

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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