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Investigating Musculoskeletal Health and Wellbeing

Investigating Musculoskeletal Health and Wellbeing: A Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03696134
Enrollment
10000
Registered
2018-10-04
Start date
2018-06-22
Completion date
2025-04-30
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Pain, Frailty, Disability

Brief 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. 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.

Interventions

OTHERquestionnaire

questionnaire

Sponsors

University of Nottingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

\- 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

Exclusion criteria

\- 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.

Design outcomes

Primary

MeasureTime frameDescription
Presence, severity and prevalence of frailty, as measured by response to the study questionnaire at annual intervals5 yearsFrailty will be classified using the 5-item FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight).
Presence and prevalence of pain5 yearsPain distribution will be recorded in a pain manikin.
Presence and prevalence of disability5 yearsDisability will be determined using the five Fried Criteria modified for questionnaire delivery.

Secondary

MeasureTime frameDescription
4. Identification of potential research participants5 yearsThe Charlson Comorbidity Index
1. Classification of phenotypic subgroups5 yearsDemographic 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).
Classification of Rheumatic Comorbid conditions5 yearsRheumatic Disease Comorbidity Index (RDCI).
Prevalence of Comorbid conditions5 yearsthe count of comorbidities
2. Classification of comorbid conditions5 yearsCo-morbidities will be assessed using the Charlson Comorbidity Index
3. Medication usage5 yearsParticipants will self-report their current medications (prescribed and over the counter).

Countries

United Kingdom

Contacts

Primary ContactBonnie Millar
bonnie.millar@nottingham.ac.uk0115 8231754

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026