NCT03696134 Investigating Musculoskeletal Health and Wellbeing
| NCT ID | NCT03696134 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nottingham |
| Condition | Musculoskeletal Pain, Frailty, Disability |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2018-06-22 |
| Primary Completion | 2025-04-30 |
Trial Parameters
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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.