Upper Limb InjuryRISMUSNCT03622190
The RISMUS Cohort Study: Risk Among Music Students.
An observational study of Upper Limb Injury, run by Queen Margaret University.
Trial summary
This observational cohort study involves repeated cross-sectional observations in order to identify those factors associated with increased risk of PRMDs among music students. All pre-college and university-level students from several European music academies will receive an invitation to complete a web-based… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Injury
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Mar 2020
- Phase
- Observational
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All pre-college and university-level students from ten music academies, with a classical instrument as main subject (composers and conductors will be excluded) will receive an invitation to complete a web-based questionnaire survey. Pre-college will include third-year and fourth-year students (age: 18 and 19 years old). University-level will include students enrolled in the first, second and third year of the Bachelor degree course (age: between 19, 20 and 22, 23 years old), as well as students enrolled in the first, second and third year of Master degree course (age: between 22, 23 and 35 years old).
Who may be able to join
- All pre-college and university-level students from music academies, with a classical instrument as main subject.
Who cannot join
- Music students without a classical instrument as main subject (composers and conductors)
- Positive history for neurological, rheumatic, psychological disorders or emotional distress, as well as surgery of the upper limbs and/or the spine in the last 12 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Longitudinal Investigation of the Factors Associated With Increased Risk of Playing-related Musculoskeletal Disorders Among Music Students
This observational cohort study involves repeated cross-sectional observations in order to identify those factors associated with increased risk of PRMDs among music students.
All pre-college and university-level students from several European music academies will receive an invitation to complete a web-based questionnaire survey at each of three occasions (baseline; 6-months follow-up; 12-months follow-up).
Read the detailed description
Professional musicians are exposed to chronic high volume of continuous and repeated physical movements, sometimes in challenging and ergonomically unfavourable anatomical body positions, in order to acquire and improve technical playing skills. As a consequence, musicians are vulnerable to developing adverse playing-related musculoskeletal disorders (PRMDs) that may affect the manner in which and the extent to which music can be practised and performed.
In order to find out effective solutions for PRMDs and to develop future preventive measures, it is fundamental to firstly identify the main risk factors that play a significant role in the development of adverse musculoskeletal (MSK) conditions and symptoms.
The longitudinal cohort study will be conducted through the following three phases:
- a baseline cross-sectional survey (i.e. web-based questionnaire) to characterise the study population and subgroups, and form the basis for the evaluation of associated factors and relationships with the development of PRMDs;
- a 6-months follow-up survey, and
- a 12-months follow-up survey.
After the first baseline data collection (Phase 1), the cohort of students will be broken down into:
- Cohort 1: music students (both pre-college and university-level) who are free of pain and PRMDs at baseline data collection
- Cohort 2: music students (both pre-college and university-level) who aren't free of pain and PRMDs at baseline data collection
Afterwards, the two cohorts will be followed and invited for reassessment at 6 months (Phase 2) and 12 months (Phase 3).
Both the follow-ups will permit longitudinal change in outcome scores to be generated and compared (longitudinal comparisons) for strength and progression of association, alongside those from absolute outcome scores at several cross-sectional analyses.
The web-based survey will include questions about any pain, PRMD and/or MSK problem they may have due to their musical practice, and different outcome measures (i.e. lifestyle and physical activity, practice habits, behaviour toward prevention and health history, level of stress, perfectionism, fatigue and disability).
The outcome measures have been selected according to the relevant findings of previous cross-sectional studies and systematic reviews among the performing arts literature.
Each outcome measure correspond to a suspected factor that may be associated with the development of a PRMD.
To the best of our knowledge, no other longitudinal studies on risk factors for PRMDs have been conducted so far. Therefore, the study can be considered as an opportunity to fill the gaps of current research on PRMDs and generate new knowledge in educational and employment musical contexts.
- Conditions
- Upper Limb Injury
- Keywords
- playing-related musculoskeletal disorder (PRMD), music students, pain, musculoskeletal (MSK) disorder
- Medical subject headings
- Arm Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Music students who are free of pain, PRMDs and/or MSK problems at baseline data collection | |
| Cohort 2 | Music students who aren't free of pain, PRMDs and/or MSK problems at baseline data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pain or musculoskeletal (MSK) disorder
The presence of pain and/or MSK problems will be assessed through the following question: "When did you last experience a bout of significant pain and/or musculoskeletal problem?"
Measured: up to 12 months
Presence of playing-related musculoskeletal disorders (PRMDs)
Self reported PRMDs according to the definition: "any pain and/or musculoskeletal problem interfered with students' ability to play their musical instrument at the level to which they are accustomed"
Measured: one month
Severity of pain or MSK disorder
Respondents are asked to assign a number, from zero (no pain) to ten (the worst possible pain), to the severity of their pain.
Measured: one month
Location of pain
Respondents are asked to indicate where they have pain and/or MSK disorders by clicking on the part(s) in which they have or have had their pain and/or MSK problem during the last month.
Measured: one month
Pain Disability Index
A short, self-report instrument for measuring the degree of interference with normal role functioning caused by pain. The respondent uses an 11-point scale ranging from 0 (no disability) to 10 (total disability) to rate the degree to which pain interferes with functioning in the following seven areas: family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life-support activity. The total score can range from 0 to 70.to participate in essential life activities.
Measured: one month
A 2-item short form of the Pain Self-efficacy Questionnaire (PSEQ-2)
Respondents are asked to rate how confidently they can perform work and normal life activities, despite their pain. They answer by circling a number on a 7-point Likert scale under each item, where 0 = not at all confident and 6= completely confident in the last month.
Measured: one month
Quick Dash - Performing Arts Section
This questions relate to the impact of your pain on playing students' practice. Respondents rate each item based on their experience over the preceding week on a 5-point Likert-type scale, increasing from 1 to 5 in level of difficulty/severity.
Measured: one week
Self-rated health (SRH)
The SHR is a simple measure which is usually assessed as a single-item: "In general, would you say your health is", with the response items "excellent," "very good," "good," "fair," or "poor" to assess health status.
Measured: 12 months
Secondary outcomes (5)
Standardised Nordic Questionnaire (SNQ)
A general questionnaire on 12-months prevalence of troubles in nine symptom sites being neck, shoulders, upper back, elbows, low back, wrist/hands, hips/thighs, knees and ankles/feet.
Measured: 12 months
Internation Physical Activity Questionnaire - short form (IPAQ-SF)
IPAQ-SF investigates the physical activity of four intensity levels (i.e. vigorous-intensity activity, moderate-intensity activity, walking, and sitting) in the past week.
Measured: one week
Kessler Psychological Distress Scale (K10)
A brief measure of non-specific psychological distress in the anxiety-depression spectrum. The K10 comprises ten questions about psychological distress designed to measure anxiety and depression. Each question is related to a specific emotional state and each has a five-level response scale. It is designed to quantify the frequency and severity of anxiety- and depression-related symptoms experienced in the past four weeks.
Measured: four weeks
Multidimensional Perfectionism Scale - short form (HFMPS-SF)
The HFMPS-SF is a 15-item questionnaire to measure trait perfectionism. Respondents rate each item on a 7-point Likert scale, increasing in level of agreement (from 1 "disagree" to 7 "agree"). Items are structured according to three subscales: self-oriented (SOP), other-oriented (OOP), and socially prescribed perfectionism (SPP), where higher scores on each scale, indicating higher levels of perfectionistic attitudes and behaviours.
Measured: 12 months
The Chalder Fatigue Scale (CFQ-11)
The CFQ-11 is a reliable measure (Cronbach α = 0.90) to assess the severity of tiredness among population (Chalder et al. 1993). Each of the eleven items are answered on a 4-point Likert-type, from 1 (asymptomatic) increasing to 4 as responses become more symptomatic. The respondent's global score can range from 0 to 33, where higher scores indicate greater tiredness. The global score also includes two dimensions-physical fatigue (measured by items 1-7) and psychological fatigue (measured by items 8-11).
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study startOct 2018 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Limb InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cinzia Cruder, Queen Margaret University
- Investigators
- Cinzia Cruder, MA, Principal investigator, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622190
- Sponsor's protocol ID
- REP 0177
- Acronym
- RISMUS
- Status last verified
- Aug 2018
- First submitted
- 31 Jul 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available. Even if made available, individual participant's information obtained as a result of this research project will be considered confidential and disclosure to third parties will be prohibited (unless required by law). It will only be the clinical information that will be shared.
Publications
Cruder C, Koufaki P, Barbero M, Gleeson N. A longitudinal investigation of the factors associated with increased RISk of playing-related musculoskeletal disorders in MUsic students (RISMUS): a study protocol. BMC Musculoskelet Disord. 2019 Feb 8;20(1):64. doi: 10.1186/s12891-019-2440-4.
PubMed 30736779
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Investigation of the Factors Associated With Increased Risk of Playing-related Musculoskeletal Disorders Among Music Students
- ClinicalTrials.gov ID
- NCT03622190
- Acronym / sponsor ID
- RISMUS / REP 0177
- Conditions
- Upper Limb Injury
- Keywords
- playing-related musculoskeletal disorder (PRMD), music students, pain, musculoskeletal (MSK) disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 9 Aug 2018 (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.
This observational cohort study involves repeated cross-sectional observations in order to identify those factors associated with increased risk of PRMDs among music students.
All pre-college and university-level students from several European music academies will receive an invitation to complete a web-based questionnaire survey at each of three occasions (baseline; 6-months follow-up; 12-months follow-up).
Detailed description
Professional musicians are exposed to chronic high volume of continuous and repeated physical movements, sometimes in challenging and ergonomically unfavourable anatomical body positions, in order to acquire and improve technical playing skills. As a consequence, musicians are vulnerable to developing adverse playing-related musculoskeletal disorders (PRMDs) that may affect the manner in which and the extent to which music can be practised and performed.
In order to find out effective solutions for PRMDs and to develop future preventive measures, it is fundamental to firstly identify the main risk factors that play a significant role in the development of adverse musculoskeletal (MSK) conditions and symptoms.
The longitudinal cohort study will be conducted through the following three phases:
- a baseline cross-sectional survey (i.e. web-based questionnaire) to characterise the study population and subgroups, and form the basis for the evaluation of associated factors and relationships with the development of PRMDs;
- a 6-months follow-up survey, and
- a 12-months follow-up survey.
After the first baseline data collection (Phase 1), the cohort of students will be broken down into:
- Cohort 1: music students (both pre-college and university-level) who are free of pain and PRMDs at baseline data collection
- Cohort 2: music students (both pre-college and university-level) who aren't free of pain and PRMDs at baseline data collection
Afterwards, the two cohorts will be followed and invited for reassessment at 6 months (Phase 2) and 12 months (Phase 3).
Both the follow-ups will permit longitudinal change in outcome scores to be generated and compared (longitudinal comparisons) for strength and progression of association, alongside those from absolute outcome scores at several cross-sectional analyses.
The web-based survey will include questions about any pain, PRMD and/or MSK problem they may have due to their musical practice, and different outcome measures (i.e. lifestyle and physical activity, practice habits, behaviour toward prevention and health history, level of stress, perfectionism, fatigue and disability).
The outcome measures have been selected according to the relevant findings of previous cross-sectional studies and systematic reviews among the performing arts literature.
Each outcome measure correspond to a suspected factor that may be associated with the development of a PRMD.
To the best of our knowledge, no other longitudinal studies on risk factors for PRMDs have been conducted so far. Therefore, the study can be considered as an opportunity to fill the gaps of current research on PRMDs and generate new knowledge in educational and employment musical contexts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Music students who are free of pain, PRMDs and/or MSK problems at baseline data collection |
| Cohort 2 | – | –Music students who aren't free of pain, PRMDs and/or MSK problems at baseline data collection |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All pre-college and university-level students from ten music academies, with a classical instrument as main subject (composers and conductors will be excluded) will receive an invitation to complete a web-based questionnaire survey. Pre-college will include third-year and fourth-year students (age: 18 and 19 years old). University-level will include students enrolled in the first, second and third year of the Bachelor degree course (age: between 19, 20 and 22, 23 years old), as well as students enrolled in the first, second and third year of Master degree course (age: between 22, 23 and 35 years old).
Key inclusion criteria (1 listed)
- All pre-college and university-level students from music academies, with a classical instrument as main subject.
Key exclusion criteria (2 listed)
- Music students without a classical instrument as main subject (composers and conductors)
- Positive history for neurological, rheumatic, psychological disorders or emotional distress, as well as surgery of the upper limbs and/or the spine in the last 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of pain or musculoskeletal (MSK) disorder
Time frame: up to 12 months
The presence of pain and/or MSK problems will be assessed through the following question: "When did you last experience a bout of significant pain and/or musculoskeletal problem?"
Presence of playing-related musculoskeletal disorders (PRMDs)
Time frame: one month
Self reported PRMDs according to the definition: "any pain and/or musculoskeletal problem interfered with students' ability to play their musical instrument at the level to which they are accustomed"
Severity of pain or MSK disorder
Time frame: one month
Respondents are asked to assign a number, from zero (no pain) to ten (the worst possible pain), to the severity of their pain.
Location of pain
Time frame: one month
Respondents are asked to indicate where they have pain and/or MSK disorders by clicking on the part(s) in which they have or have had their pain and/or MSK problem during the last month.
Pain Disability Index
Time frame: one month
A short, self-report instrument for measuring the degree of interference with normal role functioning caused by pain. The respondent uses an 11-point scale ranging from 0 (no disability) to 10 (total disability) to rate the degree to which pain interferes with functioning in the following seven areas: family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life-support activity. The total score can range from 0 to 70.to participate in essential life activities.
A 2-item short form of the Pain Self-efficacy Questionnaire (PSEQ-2)
Time frame: one month
Respondents are asked to rate how confidently they can perform work and normal life activities, despite their pain. They answer by circling a number on a 7-point Likert scale under each item, where 0 = not at all confident and 6= completely confident in the last month.
Quick Dash - Performing Arts Section
Time frame: one week
This questions relate to the impact of your pain on playing students' practice. Respondents rate each item based on their experience over the preceding week on a 5-point Likert-type scale, increasing from 1 to 5 in level of difficulty/severity.
Self-rated health (SRH)
Time frame: 12 months
The SHR is a simple measure which is usually assessed as a single-item: "In general, would you say your health is", with the response items "excellent," "very good," "good," "fair," or "poor" to assess health status.
5 secondary outcomes
Standardised Nordic Questionnaire (SNQ)
Time frame: 12 months
Internation Physical Activity Questionnaire - short form (IPAQ-SF)
Time frame: one week
Kessler Psychological Distress Scale (K10)
Time frame: four weeks
Multidimensional Perfectionism Scale - short form (HFMPS-SF)
Time frame: 12 months
The Chalder Fatigue Scale (CFQ-11)
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Derived from this study: PubMed 30736779Cruder C, Koufaki P, Barbero M, Gleeson N. A longitudinal investigation of the factors associated with increased RISk of playing-related musculoskeletal disorders in MUsic students (RISMUS): a study protocol. BMC Musculoskelet Disord. 2019 Feb 8;20(1):64. doi: 10.1186/s12891-019-2440-4.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available. Even if made available, individual participant's information obtained as a result of this research project will be considered confidential and disclosure to third parties will be prohibited (unless required by law). It will only be the clinical information that will be shared.
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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.
Cinzia Cruder, MA principal investigator
Queen Margaret University
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Limb Injury, run by Queen Margaret University.
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 1 inclusion and 2 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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Cinzia Cruder, MA (0041766938039, Ccruder@qmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of pain or musculoskeletal (MSK) disorder (time frame: up to 12 months). The study lists 8 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 NCT03622190, which also lists 1 linked publication.
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 9 Aug 2018.