- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05277649
Prevention of Musculoskeletal Injuries in Musicians
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pontevedra, Spain, 36005
- Facultade de Ciencias da Educación e do Deporte
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Woodwind or metal musicians
- University students of music performance
Exclusion Criteria:
- Any surgical intervention in cervical spine, orofacial region or temporomandibular joint.
- Analgesics or physiotherapeutic treatment in the last 24h.
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
Performance of a warm-up and cool-down exercise programme for the cervical and mandibular region before and after instrumental practice.
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Performing a programme of warm-up and stretching exercises for the cervico-mandibular region aimed at improving mobility and muscle condition.
Other Names:
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No Intervention: Control Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cervical range of movement
Time Frame: Change from baseline at 3 months
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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.
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Change from baseline at 3 months
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Temporomandibular range of movement
Time Frame: Change from baseline at 3 months
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Evaluation of the maximum jaw opening with a vernier caliper.
A vernier caliper is a validated tool to measure the MMO (maximum mouth opening).
|
Change from baseline at 3 months
|
Head position
Time Frame: Change from baseline at 3 months
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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.
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Change from baseline at 3 months
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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.
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Change from baseline at 3 months
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Cervical and orofacial pain
Time Frame: Change from baseline at 3 months
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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 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trapezius muscle activation
Time Frame: Change from baseline at 3 months
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EMG assessment of resting and maximal contraction activation of the trapezius muscle.
Surface EMG is a validated tool for measuring muscle activation.
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Change from baseline at 3 months
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Masseter muscle activation
Time Frame: Change from baseline at 3 months
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EMG assessment of resting and maximal contraction activation of the masseter muscle.
Surface EMG is a validated tool for measuring muscle activation.
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Change from baseline at 3 months
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Trapezius muscle pain threshold
Time Frame: Change from baseline at 3 months
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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.
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Change from baseline at 3 months
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Masseter muscle pain threshold
Time Frame: Change from baseline at 3 months
|
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.
|
Change from baseline at 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Margarita Pino-Juste, Professor, University of Vigo
Publications and helpful links
General 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.
- Matei 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.
- Ruivo 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.
- Steemers 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.
- Steinmetz 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.
- Steinmetz 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.
- Steinmetz 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.
- van 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.
- Zaza 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021/522
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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