Cervical and Mandibular Pain and Disorders in Wind PlayersNCT05277649
Prevention of Musculoskeletal Injuries in Musicians
A study testing Exercise programme in people with Cervical and Mandibular Pain and Disorders in Wind Players, run by Margarita Pino Juste at 1 site in Spain.
Trial summary
Musicians are a group with a high prevalence of musculoskeletal injuries. In particular, wind musicians, due to their playing requirements, are prone to suffer from cervical and mandibular alterations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical and Mandibular Pain and Disorders in Wind Players
- What is being tested?
- Exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 23 Feb 2022to Jun 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Woodwind or metal musicians
- University students of music performance
Who cannot join
- Any surgical intervention in cervical spine, orofacial region or temporomandibular joint.
- Analgesics or physiotherapeutic treatment in the last 24h.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention Programme for Cervicomandibular Musculoskeletal Injuries in Wind Musicians
Musicians are a group with a high prevalence of musculoskeletal injuries. In particular, wind musicians, due to their playing requirements, are prone to suffer from cervical and mandibular alterations.
For this reason, a specific exercise programme has been designed with the aim of analysing its effectiveness in improving these regions.
Read the detailed description
This study is a clinical trial with a control group whose participants are university music students specialising in wind instrument performance.
The intervention of the participants in the Experimental Group consists of the individual performance of a specific programme of warm-up exercises prior to instrumental practice aimed at improving the mobility and strength of the cervical and mandibular regions, as well as a series of cool-down exercises after instrumental practice based on stretching the main muscles of both regions.
Participants in the Control Group will continue their normal life without performing any specific exercise previously taught by the researchers.
For the evaluation of the programme, an initial evaluation and a re-evaluation after 12 weeks will be carried out. In both, cervical and jaw mobility as well as body posture will be assessed. In addition, at the muscular level, the activity of the upper trapezius and masseter muscles will be assessed, and the pain threshold at trigger points will also be measured.
The hypotheses are that by carrying out the exercise programme designed for wind musicians, an improvement in body posture, in the range of cervical and jaw mobility and in muscle activation will be achieved, as well as a decrease in the pain threshold.
For the study of the results, an inferential statistical analysis of the data will be carried out using the Wilcoxon test for paired data or Student's t-test for repeated measures according to the sample characteristics in order to determine the effect of the exercise programme on the different variables of the experimental process. Correlation statistics will be used to establish the association between certain quantitative explanatory variables and ANOVA for categorical variables. The level of significance will be kept at p<.05 and all calculations will be carried out using the SPSS 22.0 statistical programme.
- Being tested
- Exercise programme
- Keywords
- Musculoskeletal pain, Neck pain, Temporomandibular disorders, Posture, Musician
- Medical subject headings
- Musculoskeletal Pain, Neck Pain, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programmeOther
Also called Warm-up and cool-down exercise programme
Performing a programme of warm-up and stretching exercises for the cervico-mandibular region aimed at improving mobility and muscle condition.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Performance of a warm-up and cool-down exercise programme for the cervical and mandibular region before and after instrumental practice. Receives: Other: Exercise programme |
| Control Group | No intervention | Participants in the control group will not make any changes in their instrumental practice habit. At the end of the study, participants in the control group will be asked to perform the exercises tested in the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical range of movement
Evaluation of cervical range of motion (flexion-extension, tilts and rotations) with Kinovea software. The Kinovea software is a validated tool to measure the movements of the cervical spine.
Measured: Change from baseline at 3 months
Temporomandibular range of movement
Evaluation of the maximum jaw opening with a vernier caliper. A vernier caliper is a validated tool to measure the MMO (maximum mouth opening).
Measured: Change from baseline at 3 months
Head position
Assessment of head position by calculation of the craniovertebral angle, sagittal head angle and shoulder angle using SAPO software. SAPO is a validated tool for head posture analysis.
Measured: Change from baseline at 3 months
Head alignment
Horizontal alignment of the head and shoulders using SAPO software. SAPO is a validated tool for head posture analysis.
Measured: Change from baseline at 3 months
Cervical and 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 3 months
Secondary outcomes (4)
Trapezius muscle activation
EMG assessment of resting and maximal contraction activation of the trapezius muscle. Surface EMG is a validated tool for measuring muscle activation.
Measured: Change from baseline at 3 months
Masseter muscle activation
EMG assessment of resting and maximal contraction activation of the masseter muscle. Surface EMG is a validated tool for measuring muscle activation.
Measured: Change from baseline at 3 months
Trapezius muscle pain threshold
Pain threshold assessment at the trigger point of the upper trapezius muscle with a digital algometer. The digital algometer is a validated tool for assessing muscle pain threshold.
Measured: Change from baseline at 3 months
Masseter muscle pain threshold
Pain threshold assessment at the trigger point of the masseter muscle with a digital algometer. The digital algometer is a validated tool for assessing muscle pain threshold.
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start23 Feb 2022
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cervical and Mandibular Pain and Disorders in Wind PlayersStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of an experimental group, which will receive an intervention, and a control group, which will neither receive nor receive any intervention.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Margarita Pino Juste
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Margarita Pino Juste, University of Vigo
- Investigators
- Margarita Pino-Juste, Professor, Study director, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277649
- Sponsor's protocol ID
- 2021/522
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abreu-Ramos AM, Micheo WF. Lifetime prevalence of upper-body musculoskeletal problems in a professional-level symphony orchestra: Age, gender, and instrument-specific results. Medical Problems of Performing Artists. 2007; 22(3): 97-104.
Barton R, Feinberg J. Effectiveness of an educational program in health promotion and injury prevention for freshman music majors. Medical Problems of Performing Artists. 2008; 23: 47-53.
Elwardany SH, El-Sayed WH, Ali MF. Reliability of Kinovea Computer Program in Measuring Cervical Range of Motion in Sagittal Plane. Open Access Library Journal. 2015; 2(9): 1-10.
García-Remeseiro T, Gutierrez-Sanchez A. Analysis of relationships between the use of visual display terminals, craniocervical angle and physical activity: A pilot study. Journal of Human Sport and Exercise. 2017; 12.
Rodriguez-Blanco C, Cocera-Morata FM, Heredia-Rizo AM, Ricard F, Almazan-Campos G, Oliva-Pascual-Vaca A. Immediate Effects of Combining Local Techniques in the Craniomandibular Area and Hamstring Muscle Stretching in Subjects with Temporomandibular Disorders: A Randomized Controlled Study. J Altern Complement Med. 2015 Aug;21(8):451-9. doi: 10.1089/acm.2014.0332. Epub 2015 Jun 2.
PubMed 26218883Matei R, Ginsborg J. Physical Activity, Sedentary Behavior, Anxiety, and Pain Among Musicians in the United Kingdom. Front Psychol. 2020 Dec 3;11:560026. doi: 10.3389/fpsyg.2020.560026. eCollection 2020.
PubMed 33424675Ruivo RM, Carita AI, Pezarat-Correia P. The effects of training and detraining after an 8 month resistance and stretching training program on forward head and protracted shoulder postures in adolescents: Randomised controlled study. Man Ther. 2016 Feb;21:76-82. doi: 10.1016/j.math.2015.05.001. Epub 2015 May 13.
PubMed 26028408Steemers S, van Middelkoop M, de Boks GG, van Rijn RM, Bierma-Zeinstra SMA, Stubbe JH. The impact of injury definitions on measures of injury occurrence in classical music students: a prospective cohort study. BMC Musculoskelet Disord. 2020 Aug 11;21(1):534. doi: 10.1186/s12891-020-03490-0.
PubMed 32781988Steinmetz A, Moller H, Seidel W, Rigotti T. Playing-related musculoskeletal disorders in music students-associated musculoskeletal signs. Eur J Phys Rehabil Med. 2012 Dec;48(4):625-33. Epub 2012 Nov 9.
PubMed 23138678Steinmetz A, Scheffer I, Esmer E, Delank KS, Peroz I. Frequency, severity and predictors of playing-related musculoskeletal pain in professional orchestral musicians in Germany. Clin Rheumatol. 2015 May;34(5):965-73. doi: 10.1007/s10067-013-2470-5. Epub 2014 Jan 5.
PubMed 24389813Steinmetz A, Zeh A, Delank KS, Peroz I. Symptoms of craniomandibular dysfunction in professional orchestra musicians. Occup Med (Lond). 2014 Jan;64(1):17-22. doi: 10.1093/occmed/kqt148. Epub 2013 Dec 11.
PubMed 24336480van Selms MKA, Wiegers JW, van der Meer HA, Ahlberg J, Lobbezoo F, Visscher CM. Temporomandibular disorders, pain in the neck and shoulder area, and headache among musicians. J Oral Rehabil. 2020 Feb;47(2):132-142. doi: 10.1111/joor.12886. Epub 2019 Sep 24.
PubMed 31520546Zaza C, Farewell VT. Musicians' playing-related musculoskeletal disorders: an examination of risk factors. Am J Ind Med. 1997 Sep;32(3):292-300. doi: 10.1002/(sici)1097-0274(199709)32:33.0.co;2-q.
PubMed 9219660Rodriguez-Gude C, Taboada-Iglesias Y, Pino-Juste M. Prevention of cervical and mandibular dysfunction in wind musicians: a randomized controlled trial. Int J Occup Saf Ergon. 2026 Jun;32(2):601-608. doi: 10.1080/10803548.2025.2564526. Epub 2025 Oct 18.
PubMed 41108102
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Programme for Cervicomandibular Musculoskeletal Injuries in Wind Musicians
- ClinicalTrials.gov ID
- NCT05277649
- Acronym / sponsor ID
- 2021/522
- Keywords
- Musculoskeletal pain, Neck pain, Temporomandibular disorders, Posture, Musician
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Margarita Pino JusteUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 14 Mar 2022 (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.
Musicians are a group with a high prevalence of musculoskeletal injuries. In particular, wind musicians, due to their playing requirements, are prone to suffer from cervical and mandibular alterations.
For this reason, a specific exercise programme has been designed with the aim of analysing its effectiveness in improving these regions.
Detailed description
This study is a clinical trial with a control group whose participants are university music students specialising in wind instrument performance.
The intervention of the participants in the Experimental Group consists of the individual performance of a specific programme of warm-up exercises prior to instrumental practice aimed at improving the mobility and strength of the cervical and mandibular regions, as well as a series of cool-down exercises after instrumental practice based on stretching the main muscles of both regions.
Participants in the Control Group will continue their normal life without performing any specific exercise previously taught by the researchers.
For the evaluation of the programme, an initial evaluation and a re-evaluation after 12 weeks will be carried out. In both, cervical and jaw mobility as well as body posture will be assessed. In addition, at the muscular level, the activity of the upper trapezius and masseter muscles will be assessed, and the pain threshold at trigger points will also be measured.
The hypotheses are that by carrying out the exercise programme designed for wind musicians, an improvement in body posture, in the range of cervical and jaw mobility and in muscle activation will be achieved, as well as a decrease in the pain threshold.
For the study of the results, an inferential statistical analysis of the data will be carried out using the Wilcoxon test for paired data or Student's t-test for repeated measures according to the sample characteristics in order to determine the effect of the exercise programme on the different variables of the experimental process. Correlation statistics will be used to establish the association between certain quantitative explanatory variables and ANOVA for categorical variables. The level of significance will be kept at p<.05 and all calculations will be carried out using the SPSS 22.0 statistical programme.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study consists of an experimental group, which will receive an intervention, and a control group, which will neither receive nor receive any intervention.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Exercise programmePerformance of a warm-up and cool-down exercise programme for the cervical and mandibular region before and after instrumental practice. |
| Control Group | No intervention | –Participants in the control group will not make any changes in their instrumental practice habit. At the end of the study, participants in the control group will be asked to perform the exercises tested in the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Woodwind or metal musicians
- University students of music performance
Key exclusion criteria (3 listed)
- Any surgical intervention in cervical spine, orofacial region or temporomandibular joint.
- Analgesics or physiotherapeutic treatment in the last 24h.
- Pregnancy
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 |
|---|---|---|
| Exercise programmeAlso: Warm-up and cool-down exercise programmePerforming a programme of warm-up and stretching exercises for the cervico-mandibular region aimed at improving mobility and muscle condition. | Other | Experimental Group |
Primary outcome
Cervical range of movement
Time frame: Change from baseline at 3 months
Evaluation of cervical range of motion (flexion-extension, tilts and rotations) with Kinovea software. The Kinovea software is a validated tool to measure the movements of the cervical spine.
Temporomandibular range of movement
Time frame: Change from baseline at 3 months
Evaluation of the maximum jaw opening with a vernier caliper. A vernier caliper is a validated tool to measure the MMO (maximum mouth opening).
Head position
Time frame: Change from baseline at 3 months
Assessment of head position by calculation of the craniovertebral angle, sagittal head angle and shoulder angle using SAPO software. SAPO is a validated tool for head posture analysis.
Head alignment
Time frame: Change from baseline at 3 months
Horizontal alignment of the head and shoulders using SAPO software. SAPO is a validated tool for head posture analysis.
Cervical and orofacial pain
Time frame: Change from baseline at 3 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.
4 secondary outcomes
Trapezius muscle activation
Time frame: Change from baseline at 3 months
Masseter muscle activation
Time frame: Change from baseline at 3 months
Trapezius muscle pain threshold
Time frame: Change from baseline at 3 months
Masseter muscle pain threshold
Time frame: Change from baseline at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- BackgroundAbreu-Ramos AM, Micheo WF. Lifetime prevalence of upper-body musculoskeletal problems in a professional-level symphony orchestra: Age, gender, and instrument-specific results. Medical Problems of Performing Artists. 2007; 22(3): 97-104.
- BackgroundBarton R, Feinberg J. Effectiveness of an educational program in health promotion and injury prevention for freshman music majors. Medical Problems of Performing Artists. 2008; 23: 47-53.
- BackgroundElwardany SH, El-Sayed WH, Ali MF. Reliability of Kinovea Computer Program in Measuring Cervical Range of Motion in Sagittal Plane. Open Access Library Journal. 2015; 2(9): 1-10.
- BackgroundGarcía-Remeseiro T, Gutierrez-Sanchez A. Analysis of relationships between the use of visual display terminals, craniocervical angle and physical activity: A pilot study. Journal of Human Sport and Exercise. 2017; 12.
- Background: PubMed 26218883Rodriguez-Blanco C, Cocera-Morata FM, Heredia-Rizo AM, Ricard F, Almazan-Campos G, Oliva-Pascual-Vaca A. Immediate Effects of Combining Local Techniques in the Craniomandibular Area and Hamstring Muscle Stretching in Subjects with Temporomandibular Disorders: A Randomized Controlled Study. J Altern Complement Med. 2015 Aug;21(8):451-9. doi: 10.1089/acm.2014.0332. Epub 2015 Jun 2.
- Background: PubMed 33424675Matei R, Ginsborg J. Physical Activity, Sedentary Behavior, Anxiety, and Pain Among Musicians in the United Kingdom. Front Psychol. 2020 Dec 3;11:560026. doi: 10.3389/fpsyg.2020.560026. eCollection 2020.
- Background: PubMed 26028408Ruivo RM, Carita AI, Pezarat-Correia P. The effects of training and detraining after an 8 month resistance and stretching training program on forward head and protracted shoulder postures in adolescents: Randomised controlled study. Man Ther. 2016 Feb;21:76-82. doi: 10.1016/j.math.2015.05.001. Epub 2015 May 13.
- Background: PubMed 32781988Steemers S, van Middelkoop M, de Boks GG, van Rijn RM, Bierma-Zeinstra SMA, Stubbe JH. The impact of injury definitions on measures of injury occurrence in classical music students: a prospective cohort study. BMC Musculoskelet Disord. 2020 Aug 11;21(1):534. doi: 10.1186/s12891-020-03490-0.
- Background: PubMed 23138678Steinmetz A, Moller H, Seidel W, Rigotti T. Playing-related musculoskeletal disorders in music students-associated musculoskeletal signs. Eur J Phys Rehabil Med. 2012 Dec;48(4):625-33. Epub 2012 Nov 9.
- Background: PubMed 24389813Steinmetz A, Scheffer I, Esmer E, Delank KS, Peroz I. Frequency, severity and predictors of playing-related musculoskeletal pain in professional orchestral musicians in Germany. Clin Rheumatol. 2015 May;34(5):965-73. doi: 10.1007/s10067-013-2470-5. Epub 2014 Jan 5.
- Background: PubMed 24336480Steinmetz A, Zeh A, Delank KS, Peroz I. Symptoms of craniomandibular dysfunction in professional orchestra musicians. Occup Med (Lond). 2014 Jan;64(1):17-22. doi: 10.1093/occmed/kqt148. Epub 2013 Dec 11.
- Background: PubMed 31520546van Selms MKA, Wiegers JW, van der Meer HA, Ahlberg J, Lobbezoo F, Visscher CM. Temporomandibular disorders, pain in the neck and shoulder area, and headache among musicians. J Oral Rehabil. 2020 Feb;47(2):132-142. doi: 10.1111/joor.12886. Epub 2019 Sep 24.
- Individual participant dataSharing planned: No
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.
Margarita Pino-Juste, Professor study director
University of Vigo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise programme in people with Cervical and Mandibular Pain and Disorders in Wind Players, run by Margarita Pino Juste at 1 site 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Cervical range of movement (time frame: Change from baseline at 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05277649, which also lists 14 linked publications.
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 14 Mar 2022.