Manual Therapy Effectivity and Exercises in Musicians
Primary Purpose
Orofacial Pain
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy
Exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Orofacial Pain focused on measuring Orofacial pain, Wind musicians, Manual Therapy, Exercise program
Eligibility Criteria
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.
Sites / Locations
- Overall Study OfficialsRecruiting
- Nursing and Physiotherapy Faculty
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Wind Musicians
Wind musicians
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
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.
Pressure Pain Threshold
An algometer Wagner FPI 10-WA will be used to determine the Pressure Pain Threshold in trigger points.
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04977349
First Posted
December 1, 2020
Last Updated
August 2, 2023
Sponsor
Prof. Dr. Daniel Pecos Martín
1. Study Identification
Unique Protocol Identification Number
NCT04977349
Brief Title
Manual Therapy Effectivity and Exercises in Musicians
Official Title
Manual Therapy Effectivity Combinated or Lonely With an Exercises Program for a Wind Musicians With Orofacial Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Daniel Pecos Martín
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orofacial Pain
Keywords
Orofacial pain, Wind musicians, Manual Therapy, Exercise program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wind Musicians
Arm Type
Experimental
Arm Description
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.
Arm Title
Wind musicians
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Orofacial pain
Description
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.
Time Frame
Change from baseline at 2 months
Title
Pressure Pain Threshold
Description
An algometer Wagner FPI 10-WA will be used to determine the Pressure Pain Threshold in trigger points.
Time Frame
Change from baseline at 2 months
Title
Range of Temporo mandibular Movement
Description
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
Time Frame
Change from baseline at 2 months
Title
cervical range of movement (CROM)
Description
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.
Time Frame
Change from baseline at 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia M Merinero, PhD
Phone
661637862
Email
patricia.m.merinero@gmail.com
Facility Information:
Facility Name
Overall Study Officials
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28807
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura López-García
Phone
+34 918855142
Email
gifyd@uah.es
Facility Name
Nursing and Physiotherapy Faculty
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28871
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Fernandez-Carnero, PhD
Phone
+34620895315
Email
samuel.fernandezc@uah.es
First Name & Middle Initial & Last Name & Degree
Daniel Pecos-Martin, PhD
Phone
+34630909495
Email
daniel.pecos@uah.es
12. IPD Sharing Statement
Plan to Share IPD
No
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Manual Therapy Effectivity and Exercises in Musicians
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