Musculoskeletal PainNCT04244968
Satisfaction, QoL,Health Status & Clinic Outcomes for Patients Attending MSK Triage Clinics in Rheumatology
An observational study of Musculoskeletal Pain and Rheumatologic Disorder, run by Health Service Executive, Ireland at 1 site in Ireland.
Trial summary
The aim of this study is to measure the impact of musculoskeletal (MSK) complaints on the quality of life and general health of MSK Patients attending MSK triage clinics. The investigators will also record the proposed management options for patients' complaints. 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, Rheumatologic Disorder
- How many people
- 325 participants
- Where
- 1 siteIreland
- Study dates
- 22 Jun 2023to Jul 2026
- 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: Patients attending MSK Triage clinics in Rheumatology who meet the inclusion criteria outlined
Who may be able to join
- 18 years and over
- Patients who attend the musculoskeletal Triage Clinic in Rheumatology.
- Patients who can answer the study questionnaires independently.
Who cannot join
- Under 18 years
- Patients who present with red flag conditions, inflammatory disease or non-musculoskeletal conditions.
- Patients who cannot answer the study questionnaires independently.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Measure the Patient Satisfaction, Quality of Life, Health Status and Clinic Outcomes for Patients Attending MSK Triage Clinics in Rheumatology
The aim of this study is to measure the impact of musculoskeletal (MSK) complaints on the quality of life and general health of MSK Patients attending MSK triage clinics. The investigators will also record the proposed management options for patients' complaints. This will be achieved by asking patients to complete questionnaires (MSK HQ) at musculoskeletal triage clinic appointment, by undertaking a clinical assessment, by recording the proposed management plan and assessing if patients have follow up appointments for the same complaint in the following year. The investigators will also measure patient satisfaction using VSQ 9 Questionnaire. After a year the investigators will repeat the MSK HQ to assess the longterm impact of MSK Triage appointment on the MSK complaint.
Read the detailed description
At present there is no data available to describe the impact of musculoskeletal (MSK) disease on the Quality of life and General Health for patients attending Rheumatology MSK triage clinics in SUH and OHLM or in similar service around Ireland. A new questionnaire (MSK HQ) has been developed which has been validated in use with this population. This will be completed by the patient on the day of the appointment and again a year later. Their number of visits to secondary care in the year after their visit will also be captured and analysed. This information will inform the health service of the outcomes of these patients and the impact of their MSK disease on the health service. It will also help with resource allocation and planning for future services, which will ensure the best service for these patients in the future.
Alongside this, Patient satisfaction and feedback is vital to ensuring service quality and quality improvement. The VSQ 9 will be used to measure Patient Satisfaction in this study to evaluate if patients are satisfied with the service they have received on the day. The repeated MSK HQ will help identify if their triage clinic appointment was beneficial to their Quality of life.
- Conditions
- Musculoskeletal Pain, Rheumatologic Disorder
- Keywords
- Physiotherapy Triage, Musculoskeletal Pain, Patient Satisfaction VSQ 9, MSK HQ
- Medical subject headings
- Musculoskeletal Pain, Collagen Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal Health Questionnaire
Self Reported Questionnaire measuring patients health status, Score range 0 -56, with better score indicating better health status
Measured: Baseline
Secondary outcomes (2)
Visit-Specific Satisfaction Questionnaire version 9
Patient Satisfaction Questionnaire, Score range 9 - 45, with higher scores indicating lower patient satisifaction
Measured: Baseline
Change in Musculoskeletal Health Questionnaire
Self Reported Questionnaire measuring patients health status, Score range 0 -56, with better score indicating better health status
Measured: One year post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start22 Jun 2023
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health Service Executive, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Heraughty, Health Service Executive, Ireland
- Investigators
- Michelle Heraughty, MSc, Principal investigator, HSE Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244968
- Sponsor's protocol ID
- REC SUH 763
- Status last verified
- Oct 2024
- First submitted
- 22 Jan 2020
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hill JC, Kang S, Benedetto E, Myers H, Blackburn S, Smith S, Dunn KM, Hay E, Rees J, Beard D, Glyn-Jones S, Barker K, Ellis B, Fitzpatrick R, Price A. Development and initial cohort validation of the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways. BMJ Open. 2016 Aug 5;6(8):e012331. doi: 10.1136/bmjopen-2016-012331.
PubMed 27496243Kennedy DM, Robarts S, Woodhouse L. Patients are satisfied with advanced practice physiotherapists in a role traditionally performed by orthopaedic surgeons. Physiother Can. 2010 Fall;62(4):298-305. doi: 10.3138/physio.62.4.298. Epub 2010 Oct 18.
PubMed 21886368Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.
PubMed 24049221
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Measure the Patient Satisfaction, Quality of Life, Health Status and Clinic Outcomes for Patients Attending MSK Triage Clinics in Rheumatology
- ClinicalTrials.gov ID
- NCT04244968
- Acronym / sponsor ID
- REC SUH 763
- Conditions
- Musculoskeletal Pain, Rheumatologic Disorder
- Keywords
- Physiotherapy Triage, Musculoskeletal Pain, Patient Satisfaction VSQ 9, MSK HQ
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Health Service Executive, IrelandUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 28 Jan 2020 (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 is to measure the impact of musculoskeletal (MSK) complaints on the quality of life and general health of MSK Patients attending MSK triage clinics. The investigators will also record the proposed management options for patients' complaints. This will be achieved by asking patients to complete questionnaires (MSK HQ) at musculoskeletal triage clinic appointment, by undertaking a clinical assessment, by recording the proposed management plan and assessing if patients have follow up appointments for the same complaint in the following year. The investigators will also measure patient satisfaction using VSQ 9 Questionnaire. After a year the investigators will repeat the MSK HQ to assess the longterm impact of MSK Triage appointment on the MSK complaint.
Detailed description
At present there is no data available to describe the impact of musculoskeletal (MSK) disease on the Quality of life and General Health for patients attending Rheumatology MSK triage clinics in SUH and OHLM or in similar service around Ireland. A new questionnaire (MSK HQ) has been developed which has been validated in use with this population. This will be completed by the patient on the day of the appointment and again a year later. Their number of visits to secondary care in the year after their visit will also be captured and analysed. This information will inform the health service of the outcomes of these patients and the impact of their MSK disease on the health service. It will also help with resource allocation and planning for future services, which will ensure the best service for these patients in the future.
Alongside this, Patient satisfaction and feedback is vital to ensuring service quality and quality improvement. The VSQ 9 will be used to measure Patient Satisfaction in this study to evaluate if patients are satisfied with the service they have received on the day. The repeated MSK HQ will help identify if their triage clinic appointment was beneficial to their Quality of life.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending MSK Triage clinics in Rheumatology who meet the inclusion criteria outlined
Key inclusion criteria (3 listed)
- 18 years and over
- Patients who attend the musculoskeletal Triage Clinic in Rheumatology.
- Patients who can answer the study questionnaires independently.
Key exclusion criteria (3 listed)
- Under 18 years
- Patients who present with red flag conditions, inflammatory disease or non-musculoskeletal conditions.
- Patients who cannot answer the study questionnaires independently.
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
Musculoskeletal Health Questionnaire
Time frame: Baseline
Self Reported Questionnaire measuring patients health status, Score range 0 -56, with better score indicating better health status
2 secondary outcomes
Visit-Specific Satisfaction Questionnaire version 9
Time frame: Baseline
Change in Musculoskeletal Health Questionnaire
Time frame: One year post baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 27496243Hill JC, Kang S, Benedetto E, Myers H, Blackburn S, Smith S, Dunn KM, Hay E, Rees J, Beard D, Glyn-Jones S, Barker K, Ellis B, Fitzpatrick R, Price A. Development and initial cohort validation of the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways. BMJ Open. 2016 Aug 5;6(8):e012331. doi: 10.1136/bmjopen-2016-012331.
- Background: PubMed 21886368Kennedy DM, Robarts S, Woodhouse L. Patients are satisfied with advanced practice physiotherapists in a role traditionally performed by orthopaedic surgeons. Physiother Can. 2010 Fall;62(4):298-305. doi: 10.3138/physio.62.4.298. Epub 2010 Oct 18.
- Background: PubMed 24049221Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.
- 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.
Michelle Heraughty, MSc principal investigator
HSE Ireland
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 Rheumatologic Disorder, run by Health Service Executive, Ireland at 1 site in Ireland.
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 3 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 4 Oct 2024. 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 Ireland. 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?
Musculoskeletal Health Questionnaire (time frame: Baseline). 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 NCT04244968, which also lists 3 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 4 Oct 2024.