Musculoskeletal Pain, Frailty, DisabilityNCT03696134
Investigating Musculoskeletal Health and Wellbeing
An observational study of Musculoskeletal Pain, Frailty, Disability, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Background The progression and associations of central and peripheral musculoskeletal pain, frailty, disability and fracture risks are not well known. This study aims to characterise the development and progression of different frailty, pain and disability phenotypes and their individual associations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain, Frailty, Disability
- What is being tested?
- questionnaire
- How many people
- 10,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jun 2018to 30 Apr 2025
- 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
- Adult, Older adult
Study population: Participants will be recruited from a broad range of sources, including the community, primary and secondary care health services. Diverse recruitment pathways will enable enrichment of the cohort with participants from a range of backgrounds and suitable for a range of potential interventions aiming to reduce frailty, pain or disability. Participants may be recruited from GP surgeries, community based clinics, Musculoskeletal Pathway (Physiotherapy and occupational health clinics in primary care), hospital patient waiting lists, hospital outpatients' lists and physiotherapy services, or as participants from previous studies undertaken by the University of Nottingham or Nottingham University Hospitals NHS Trust who have expressed an interest in future research, and people who respond to online material.
Who may be able to join
- Ability to give informed consent. Aged 18 and over Frailty score of ≥ 0.12 on the eFI Have or are at risk of developing musculoskeletal frailty, pain or disability
Who cannot join
- Inadequate understanding of verbal explanations or written information in English; Special communication needs; Receiving dialysis; Receiving home oxygen; Terminal cancer; Unstable angina or heart failure; Serious mental illness; Dementia.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Nottingham
Nottingham, NG5 1PB
Bonnie Millar
About this study
Official title: Investigating Musculoskeletal Health and Wellbeing: A Cohort Study
Background The progression and associations of central and peripheral musculoskeletal pain, frailty, disability and fracture risks are not well known. This study aims to characterise the development and progression of different frailty, pain and disability phenotypes and their individual associations.
Methods A prospective cohort of 10000 people aged > 18 will be recruited from general practice surgeries, secondary care and the general public. Data collection waves will be at baseline,and then annual follow-ups for up to five years. Data will be collected using a questionnaire asking about demographic characteristics, pain severity (0-10 scales), pain distribution (a pain Mannikin), pain quality (the McGill Pain Questionnaire), central pain (the CAP-Knee Scale), fracture risks (a modified version of the FRAX instrument), frailty (the Fried Criteria and the FRAIL scale) and disability (the FRAIL scale).
Discussion Participant data will be analysed to determine phenotypic subgroups of frailty, pain and disability. Further to this, the progression of these characteristics and their influences upon health and wellbeing will be quantified.
- Being tested
- questionnaire
- Medical subject headings
- Musculoskeletal Pain, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence, severity and prevalence of frailty, as measured by response to the study questionnaire at annual intervals
Frailty will be classified using the 5-item FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, \& Loss of Weight).
Measured: 5 years
Presence and prevalence of pain
Pain distribution will be recorded in a pain manikin.
Measured: 5 years
Presence and prevalence of disability
Disability will be determined using the five Fried Criteria modified for questionnaire delivery.
Measured: 5 years
Secondary outcomes (6)
1. Classification of phenotypic subgroups
Demographic characteristics will be recorded; age at baseline, sex, race, socioeconomic position (deprivation index, urban/rural indicators will be derived from postcode data), smoking habits, weight, height and alcohol consumption. Fracture risk will be assessed using a modified version of the FRAX instrument (substituting secondary osteoporosis for self-reported osteoporosis and without using data for bone mineral density measurements).
Measured: 5 years
2. Classification of comorbid conditions
Co-morbidities will be assessed using the Charlson Comorbidity Index
Measured: 5 years
3. Medication usage
Participants will self-report their current medications (prescribed and over the counter).
Measured: 5 years
4. Identification of potential research participants
The Charlson Comorbidity Index
Measured: 5 years
Prevalence of Comorbid conditions
the count of comorbidities
Measured: 5 years
Classification of Rheumatic Comorbid conditions
Rheumatic Disease Comorbidity Index (RDCI).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start22 Jun 2018
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal Pain, Frailty, DisabilityStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Walsh, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696134
- Sponsor's protocol ID
- 17113
- Status last verified
- Jun 2024
- First submitted
- 17 Sep 2018
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Millar B, McWilliams DF, Abhishek A, Akin-Akinyosoye K, Auer DP, Chapman V, Doherty M, Ferguson E, Gladman JRF, Greenhaff P, Stocks J, Valdes AM, Walsh DA. Investigating musculoskeletal health and wellbeing; a cohort study protocol. BMC Musculoskelet Disord. 2020 Mar 21;21(1):182. doi: 10.1186/s12891-020-03195-4.
PubMed 32199451Chaplin WJ, McWilliams DF, Millar BS, Gladman JRF, Walsh DA. The bidirectional relationship between chronic joint pain and frailty: data from the Investigating Musculoskeletal Health and Wellbeing cohort. BMC Geriatr. 2023 May 5;23(1):273. doi: 10.1186/s12877-023-03949-4.
PubMed 37147635
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Musculoskeletal Health and Wellbeing: A Cohort Study
- ClinicalTrials.gov ID
- NCT03696134
- Acronym / sponsor ID
- 17113
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 4 Oct 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.
Background The progression and associations of central and peripheral musculoskeletal pain, frailty, disability and fracture risks are not well known. This study aims to characterise the development and progression of different frailty, pain and disability phenotypes and their individual associations.
Methods A prospective cohort of 10000 people aged > 18 will be recruited from general practice surgeries, secondary care and the general public. Data collection waves will be at baseline,and then annual follow-ups for up to five years. Data will be collected using a questionnaire asking about demographic characteristics, pain severity (0-10 scales), pain distribution (a pain Mannikin), pain quality (the McGill Pain Questionnaire), central pain (the CAP-Knee Scale), fracture risks (a modified version of the FRAX instrument), frailty (the Fried Criteria and the FRAIL scale) and disability (the FRAIL scale).
Discussion Participant data will be analysed to determine phenotypic subgroups of frailty, pain and disability. Further to this, the progression of these characteristics and their influences upon health and wellbeing will be quantified.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from a broad range of sources, including the community, primary and secondary care health services. Diverse recruitment pathways will enable enrichment of the cohort with participants from a range of backgrounds and suitable for a range of potential interventions aiming to reduce frailty, pain or disability. Participants may be recruited from GP surgeries, community based clinics, Musculoskeletal Pathway (Physiotherapy and occupational health clinics in primary care), hospital patient waiting lists, hospital outpatients' lists and physiotherapy services, or as participants from previous studies undertaken by the University of Nottingham or Nottingham University Hospitals NHS Trust who have expressed an interest in future research, and people who respond to online material.
Key inclusion criteria (1 listed)
- Ability to give informed consent. Aged 18 and over Frailty score of ≥ 0.12 on the eFI Have or are at risk of developing musculoskeletal frailty, pain or disability
Key exclusion criteria (1 listed)
- Inadequate understanding of verbal explanations or written information in English; Special communication needs; Receiving dialysis; Receiving home oxygen; Terminal cancer; Unstable angina or heart failure; Serious mental illness; Dementia.
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 |
|---|---|---|
| questionnairequestionnaire | Other | – |
Primary outcome
Presence, severity and prevalence of frailty, as measured by response to the study questionnaire at annual intervals
Time frame: 5 years
Frailty will be classified using the 5-item FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, \& Loss of Weight).
Presence and prevalence of pain
Time frame: 5 years
Pain distribution will be recorded in a pain manikin.
Presence and prevalence of disability
Time frame: 5 years
Disability will be determined using the five Fried Criteria modified for questionnaire delivery.
6 secondary outcomes
1. Classification of phenotypic subgroups
Time frame: 5 years
2. Classification of comorbid conditions
Time frame: 5 years
3. Medication usage
Time frame: 5 years
4. Identification of potential research participants
Time frame: 5 years
Prevalence of Comorbid conditions
Time frame: 5 years
Classification of Rheumatic Comorbid conditions
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Background: PubMed 32199451Millar B, McWilliams DF, Abhishek A, Akin-Akinyosoye K, Auer DP, Chapman V, Doherty M, Ferguson E, Gladman JRF, Greenhaff P, Stocks J, Valdes AM, Walsh DA. Investigating musculoskeletal health and wellbeing; a cohort study protocol. BMC Musculoskelet Disord. 2020 Mar 21;21(1):182. doi: 10.1186/s12891-020-03195-4.
- Derived from this study: PubMed 37147635Chaplin WJ, McWilliams DF, Millar BS, Gladman JRF, Walsh DA. The bidirectional relationship between chronic joint pain and frailty: data from the Investigating Musculoskeletal Health and Wellbeing cohort. BMC Geriatr. 2023 May 5;23(1):273. doi: 10.1186/s12877-023-03949-4.
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.
David Walsh principal investigator
University of Nottingham
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, Frailty, Disability, run by University of Nottingham at 1 site in United Kingdom.
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 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 21 Jun 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 United Kingdom. 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?
Contact Bonnie Millar (0115 8231754, bonnie.millar@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence, severity and prevalence of frailty, as measured by response to the study questionnaire at annual intervals (time frame: 5 years). The study lists 3 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 NCT03696134, which also lists 2 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 21 Jun 2024.