Musculoskeletal PainNCT05903300
Validation of the Polish Version of the MPIIQM Questionnaire for Musicians
An observational study of Musculoskeletal Pain and Questionnaire, run by Anna Cygańska at 1 site in Poland.
Trial summary
The aim of this study, originally named "Cross-Cultural Adaptation and Validation of the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians of the Polish Population (MPIIQM-P)" is the enlargement of validation of the Polish questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Questionnaire
- What is being tested?
- Surveys and Questionnaires
- How many people
- 182 participants
- Where
- 1 sitePoland
- Study dates
- 17 Apr 2023to 1 Dec 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study group consists of adult, professionally active people (women and men) who are professional orchestra musicians. The mother tongue of the respondents must be Polish.
Who may be able to join
- permanent musician in an orchestra
- Polish as a native language
Who cannot join
- freelance musician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Polish Version of the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians (MPIIQM-P)
The aim of this study, originally named "Cross-Cultural Adaptation and Validation of the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians of the Polish Population (MPIIQM-P)" is the enlargement of validation of the Polish questionnaire.
Read the detailed description
The aim is to determine the following psychometric properties: convergent and divergent validity, two-time reliability analysis, and exploratory factor analysis according to the recommended number of subjects of ≥45 subjects. In addition, the aim of the study is to assess the psychometric properties of the MPIIQM-P questionnaire in the online version and to compare these results with the results for the paper version obtained by Cygańska et al., 2021.
- Conditions
- Musculoskeletal Pain, Questionnaire
- Being tested
- Surveys and Questionnaires
- Keywords
- Occupational Diseases, Musculoskeletal Pain, Questionnaires, Validation Studies, Pain Measurement
- Medical subject headings
- Musculoskeletal Pain, Occupational Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surveys and QuestionnairesOther
The intervention consists of completing the MIPIM-P, QuickDash, and Brief Pain Inventory questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Professional orchestra musicians | The study group consists of adult, professionally active people (women and men) who are professional orchestra musicians. The mother tongue of the respondents must be Polish. Receives: Other: Surveys and Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity MPIQIM
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P); The pain intensity score can be defined as the sum of the four pain intensity items (0-40, the higher the score, the greater the pain intensity) or the mean of pain intensity score (0-10, the higher the score, the greater the pain intensity).
Measured: Baseline and change between baseline and after few (3/4) days
Pain Intensity BPI
In Brief Pain Inventory, subjects rates their pain intensity on a numeric rating scale from 0 to 10, the higher the score, the greater the pain intensity. The pain intensity score can be defined as the sum of the four pain intensity items (0-40, the higher the score, the greater the pain intensity). In the inventory, a score of 1-4 is defined as mild pain, a score of 5-6 as moderate pain, and a score of 7-10 as severe pain.
Measured: Baseline and change between baseline and after few (3/4) days
Pain Interference MPIQIM
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P); The pain interference score can be defined as the sum of the four pain interference items (0-50, the higher the score, the greater the pain interference) or the mean of pain interference score (0-10, the higher the score, the greater the pain interference).
Measured: Baseline
Pain Interference BPI
In Brief Pain Inventory, subjects rate their pain interference on a numeric rating scale from 0 to 10, the higher the score, the greater the pain interference. The pain interference score can be defined as the sum of the four pain interference items (0-70, the higher the score, the greater the pain intensity) or the mean of the pain interference score (0-10, the higher the score, the greater the pain interference).
Measured: Baseline
Pain Interference
In Quick Dash Questionaire, subjects rate their pain interference on a numeric rating scale from 0 to 5, the higher the score, the greater the pain interference. The pain interference score can be defined as the sum of the selected answers, divided by 4 (i.e. number of questions), subtracting 1, and multiply by 25.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start17 Apr 2023
- Primary completion28 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anna Cygańska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Cygańska, Józef Piłsudski University of Physical Education
- Investigators
- Anna K. Cygańska, Cygańska, Principal investigator, Józef Piłsudski University of Physical Education in Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903300
- Sponsor's protocol ID
- SKE 01-01/2023
- Status last verified
- Jul 2023
- First submitted
- 5 Jun 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Polish Version of the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians (MPIIQM-P)
- ClinicalTrials.gov ID
- NCT05903300
- Acronym / sponsor ID
- SKE 01-01/2023
- Conditions
- Musculoskeletal Pain, Questionnaire
- Keywords
- Occupational Diseases, Musculoskeletal Pain, Questionnaires, Validation Studies, Pain Measurement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Anna CygańskaUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 28 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 15 Jun 2023 (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.
The aim of this study, originally named "Cross-Cultural Adaptation and Validation of the Musculoskeletal Pain Intensity and Interference Questionnaire for Musicians of the Polish Population (MPIIQM-P)" is the enlargement of validation of the Polish questionnaire.
Detailed description
The aim is to determine the following psychometric properties: convergent and divergent validity, two-time reliability analysis, and exploratory factor analysis according to the recommended number of subjects of ≥45 subjects. In addition, the aim of the study is to assess the psychometric properties of the MPIIQM-P questionnaire in the online version and to compare these results with the results for the paper version obtained by Cygańska et al., 2021.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Professional orchestra musicians | – | Other: Surveys and QuestionnairesThe study group consists of adult, professionally active people (women and men) who are professional orchestra musicians. The mother tongue of the respondents must be Polish. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study group consists of adult, professionally active people (women and men) who are professional orchestra musicians. The mother tongue of the respondents must be Polish.
Key inclusion criteria (2 listed)
- permanent musician in an orchestra
- Polish as a native language
Key exclusion criteria (1 listed)
- freelance musician
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 |
|---|---|---|
| Surveys and QuestionnairesThe intervention consists of completing the MIPIM-P, QuickDash, and Brief Pain Inventory questionnaires. | Other | Professional orchestra musicians |
Primary outcome
Pain Intensity MPIQIM
Time frame: Baseline and change between baseline and after few (3/4) days
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P); The pain intensity score can be defined as the sum of the four pain intensity items (0-40, the higher the score, the greater the pain intensity) or the mean of pain intensity score (0-10, the higher the score, the greater the pain intensity).
Pain Intensity BPI
Time frame: Baseline and change between baseline and after few (3/4) days
In Brief Pain Inventory, subjects rates their pain intensity on a numeric rating scale from 0 to 10, the higher the score, the greater the pain intensity. The pain intensity score can be defined as the sum of the four pain intensity items (0-40, the higher the score, the greater the pain intensity). In the inventory, a score of 1-4 is defined as mild pain, a score of 5-6 as moderate pain, and a score of 7-10 as severe pain.
Pain Interference MPIQIM
Time frame: Baseline
The Musculoskeletal Pain Intensity and Interference Questionnaire for professional orchestra Musicians of the Polish Population (MPIIQM-P); The pain interference score can be defined as the sum of the four pain interference items (0-50, the higher the score, the greater the pain interference) or the mean of pain interference score (0-10, the higher the score, the greater the pain interference).
Pain Interference BPI
Time frame: Baseline
In Brief Pain Inventory, subjects rate their pain interference on a numeric rating scale from 0 to 10, the higher the score, the greater the pain interference. The pain interference score can be defined as the sum of the four pain interference items (0-70, the higher the score, the greater the pain intensity) or the mean of the pain interference score (0-10, the higher the score, the greater the pain interference).
Pain Interference
Time frame: Baseline
In Quick Dash Questionaire, subjects rate their pain interference on a numeric rating scale from 0 to 5, the higher the score, the greater the pain interference. The pain interference score can be defined as the sum of the selected answers, divided by 4 (i.e. number of questions), subtracting 1, and multiply by 25.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- 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.
Anna K. Cygańska, Cygańska principal investigator
Józef Piłsudski University of Physical Education in Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain and Questionnaire, run by Anna Cygańska at 1 site in Poland.
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 1 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 25 Jul 2023. 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 Poland. 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?
Pain Intensity MPIQIM (time frame: Baseline and change between baseline and after few (3/4) days). 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?
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 25 Jul 2023.