NCT06758349

Brief Summary

This is an observational study that will allow to understand if and how posture at the instrument can affect musician health and ability to work. The study will last 3 years during which the investigators will evaluate 250 orchestral players: all musical instruments will be included. Postural assessments will be performed in the various venues of the participating orchestras. The study participant, would initially answer a questionnaire that will investigate lifestyle habits (physical activity), professional activity (e.g. instrument played, hours of study/work, study methods) and general health (e.g. presence of pain with functional limitation at the present time or in the past, diagnosis of scoliosis). The subsequent postural assessment will consist of two phases: phase 1 without an instrument in a sitting position, phase 2 with the musical instrument . Disposable ECG electrodes will be applied to the skin and will serve as landmarks and will be removed at the end of the assessment. In both phases, the Physical Analyzer Portable system will be used, which allows the acquisition of calibrated photographs and the subsequent processing of the data obtained through special software, calculating with numerical values the postural asymmetries between the right and left sides and the degrees of inclination of the trunk. The execution of the planned assessments will take place in the constant presence and under the guidance and control of suitable and qualified personnel who will provide instructions on the activity to be carried out and assistance in case of any need. The data obtained in this way will be correlated with the information collected with the questionnaire. Improving musician posture awareness with the musical instrument could prevent the onset of pain and limitations in work activity. In fact, the identification of risk factors for musculoskeletal pathologies in professional musicians (PRMDs) would allow the development of specific prevention and treatment programs and the development of a network of territorial services dedicated to the musicians themselves.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 3, 2025

Status Verified

November 1, 2024

Enrollment Period

2.1 years

First QC Date

July 12, 2024

Last Update Submit

January 2, 2025

Conditions

Keywords

Abnormal postureMusicianPainfunctional limitation

Outcome Measures

Primary Outcomes (2)

  • Pain, Limitation and Posture last week

    The investigators will evaluate if there is a correlation between pain with and without functional limitation with the following measure: trunk inclination, cervical inclination, dorsal curve, lumbar curve , right shoulder position, right shoulder height, right scapulae, left shoulder position, left shoulder height, left scapulae last week before the assessment

    the week prior to the assessment

  • Pain, Limitation and Posture last six months

    The investigators will evaluate if there is a correlation between pain with and without functional limitation with the following measure: trunk inclination, cervical inclination, dorsal curve, lumbar curve , right shoulder position, right shoulder height, right scapulae, left shoulder position, left shoulder height, left scapulae during the last 6 months before the assessment

    the six months prior to the assessment

Secondary Outcomes (17)

  • Prevalance of pain without functional limitation during last week

    the week prior to the assessment

  • Prevalence of pain without functional limitation during last six months

    the six months prior to the assessment

  • Prevalance of pain with functional limitation during last week

    the week prior to the assessment

  • Prevalence of pain with functional limitation during last six months

    the six months prior to the assessment

  • Pain with o without functional limitation during last week and personal and playing habit

    the week prior to the assessment

  • +12 more secondary outcomes

Study Arms (1)

Orchestral musicians

The enrolled sample will consist of 250 professional musicians from major Italian orchestras.

Other: General questionnaireOther: Pain QuestionnaireOther: Postural assessment without musical instrument in sitting positionOther: Postural assessment with the instrument in sitting position.

Interventions

Demographic, medical history, and musical activity data will be collected using a specifically designed questionnaire

Orchestral musicians

Questionnaire that evaluate pain and functional limitation during last week, last six months e during the carrier. The impact of painful symptoms on professional and non-professional activities , during the last week, will be assessed using the QuickDASH scale for the upper limb, the Modified Oswestry Low Back Disability Index for low back pain, and the Neck Disability Index questionnaire for cervico-dorsalgia

Orchestral musicians

Postural assessment without the instrument in a sitting position. Disposable ECG electrodes will be applied to the following anatomical landmarks: Spinous process C7 (C7), Right shoulder acromion (RS), Left shoulder acromion (LS), Right scapula inferior angle (RIA), Left scapula inferior angle (LIA), Spinous process L3 (L3), Intergluteal line (IG), vertex. The Physical Analyzer Portable will be used: a non-invasive, portable device that allows calibrated photo acquisition on the frontal and sagittal planes and subsequent data processing through dedicated software. On frontal plane they will be calculated: Trunk inclination, Head-neck inclination, Right and left shoulder height, Right and left shoulder width, right and left scapula-rachis distance. On sagittal plane they will be calculated: cervical and lumbar arrow, right and left shoulder distance.

Orchestral musicians

Postural assessment with the instrument in a sitting position. Disposable ECG electrodes will be applied to the following anatomical landmarks: Spinous process C7 (C7), Right shoulder acromion (RS), Left shoulder acromion (LS), Right scapula inferior angle (RIA), Left scapula inferior angle (LIA), Spinous process L3 (L3), Intergluteal line (IG), vertex. The Physical Analyzer Portable will be used: a non-invasive, portable device that allows calibrated photo acquisition on the frontal and sagittal planes and subsequent data processing through dedicated software. On frontal plane they will be calculated: Trunk inclination, Head-neck inclination, Right and left shoulder height, Right and left shoulder width, right and left scapula-rachis distance. On sagittal plane they will be calculated: cervical and lumbar arrow, right and left shoulder distance.

Orchestral musicians

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

orchestral musicians playing symmetrical and asymmetrical musical instruments

You may qualify if:

  • Professional musicians from major Italian orchestras

You may not qualify if:

  • \- Pain associated with acute trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Santa Maria Nascente Fondazione Don Carlo Gnocchi

Milan, MI, 20148, Italy

RECRUITING

Related Publications (6)

  • Ramella M, Fronte F, Converti RM. Postural disorders in conservatory students: the Diesis project. Med Probl Perform Art. 2014 Mar;29(1):19-22. doi: 10.21091/mppa.2014.1005.

    PMID: 24647457BACKGROUND
  • undefined

    BACKGROUND
  • 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.

    PMID: 24389813BACKGROUND
  • Kok LM, Huisstede BM, Voorn VM, Schoones JW, Nelissen RG. The occurrence of musculoskeletal complaints among professional musicians: a systematic review. Int Arch Occup Environ Health. 2016 Apr;89(3):373-96. doi: 10.1007/s00420-015-1090-6. Epub 2015 Nov 12.

    PMID: 26563718BACKGROUND
  • Cruder C, Barbero M, Koufaki P, Soldini E, Gleeson N. Prevalence and associated factors of playing-related musculoskeletal disorders among music students in Europe. Baseline findings from the Risk of Music Students (RISMUS) longitudinal multicentre study. PLoS One. 2020 Dec 9;15(12):e0242660. doi: 10.1371/journal.pone.0242660. eCollection 2020.

    PMID: 33296381BACKGROUND
  • Zaza C, Charles C, Muszynski A. The meaning of playing-related musculoskeletal disorders to classical musicians. Soc Sci Med. 1998 Dec;47(12):2013-23. doi: 10.1016/s0277-9536(98)00307-4.

    PMID: 10075243BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Sitting Position

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Rosa Maria Converti, Physiatrist doctor

CONTACT

Marina Ramella, Physiatrist doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2024

First Posted

January 3, 2025

Study Start

May 5, 2023

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

January 3, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations