Orofacial PainNCT04977349
Manual Therapy Effectivity and Exercises in Musicians
A study testing Manual Therapy and Exercise program in people with Orofacial Pain, run by Prof. Dr. Daniel Pecos Martín at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orofacial Pain
- What is being tested?
- Manual Therapy and Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Sep 2021to 10 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Overall Study Officials
Alcalá de Henares, Madrid, 28807
Nursing and Physiotherapy Faculty
Alcalá de Henares, Madrid, 28871
About this study
Official title: 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.
Read the 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.
- Conditions
- Orofacial Pain
- Being tested
- Manual Therapy, Exercise program
- Keywords
- Orofacial pain, Wind musicians, Manual Therapy, Exercise program
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Manual Therapy; Other: 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). Receives: Other: Manual Therapy; Other: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Change from baseline at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Sep 2021
- Primary completion10 Feb 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orofacial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Daniel Pecos Martín
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977349
- Sponsor's protocol ID
- CEIM/HU/2020/40
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2020
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Therapy Effectivity Combinated or Lonely With an Exercises Program for a Wind Musicians With Orofacial Pain
- ClinicalTrials.gov ID
- NCT04977349
- Acronym / sponsor ID
- CEIM/HU/2020/40
- Conditions
- Orofacial Pain
- Keywords
- Orofacial pain, Wind musicians, Manual Therapy, Exercise program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prof. Dr. Daniel Pecos MartínUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wind Musicians | Experimental | Other: Manual Therapy, Other: Exercise programIsometric exercises for: cranial protrusion, mouth opening, laterality cervical movement and cervical coordination by laser assesment. And the manual therapy from the Active Comparator group. |
| Wind musicians | Active comparator | Other: Manual Therapy, Other: Exercise programThis 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual TherapyThis 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 | Wind Musicians, Wind musicians |
| Exercise programIsometric exercises for: cranial protrusion, mouth opening, laterality cervical movement and cervical coordination by laser assessment. And the manual therapy from the Active Comparator group. | Other | Wind Musicians, Wind musicians |
Primary outcome
Orofacial pain
Time frame: Change from baseline at 2 months
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
Time frame: Change from baseline at 2 months
An algometer Wagner FPI 10-WA will be used to determine the Pressure Pain Threshold in trigger points.
Range of Temporo mandibular Movement
Time frame: Change from baseline at 2 months
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)
Time frame: Change from baseline at 2 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Exercise program in people with Orofacial Pain, run by Prof. Dr. Daniel Pecos Martín at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orofacial pain (time frame: Change from baseline at 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.