Clinical trial NCT03696134: Investigating Musculoskeletal Health and Wellbeing
Official title: Investigating Musculoskeletal Health and Wellbeing: A Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Musculoskeletal Pain, Frailty, Disability
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Presence, severity and prevalence of frailty, as measured by response to the study questionnaire at annual intervals
timeFrame: 5 years
measure: Presence and prevalence of pain
timeFrame: 5 years
measure: Presence and prevalence of disability
timeFrame: 5 years
Secondary outcomes:
measure: 1. Classification of phenotypic subgroups
timeFrame: 5 years
measure: 2. Classification of comorbid conditions
timeFrame: 5 years
measure: 3. Medication usage
timeFrame: 5 years
measure: 4. Identification of potential research participants
timeFrame: 5 years
measure: Prevalence of Comorbid conditions
timeFrame: 5 years
measure: Classification of Rheumatic Comorbid conditions
timeFrame: 5 years
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
affiliation: University of Nottingham
name: David Walsh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.