Musculoskeletal Pain, Frailty, Disability Clinical Trial
Official title:
Investigating Musculoskeletal Health and Wellbeing: A Cohort Study
| NCT number | NCT03696134 |
| Other study ID # | 17113 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 22, 2018 |
| Est. completion date | April 30, 2025 |
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.
| Status | Recruiting |
| Enrollment | 10000 |
| Est. completion date | April 30, 2025 |
| Est. primary completion date | April 30, 2025 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University of Nottingham | Nottingham |
| Lead Sponsor | Collaborator |
|---|---|
| University of Nottingham |
United Kingdom,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | 5 years | |
| Primary | Presence and prevalence of pain | Pain distribution will be recorded in a pain manikin. | 5 years | |
| Primary | Presence and prevalence of disability | Disability will be determined using the five Fried Criteria modified for questionnaire delivery. | 5 years | |
| Secondary | 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). | 5 years | |
| Secondary | 2. Classification of comorbid conditions | Co-morbidities will be assessed using the Charlson Comorbidity Index | 5 years | |
| Secondary | 3. Medication usage | Participants will self-report their current medications (prescribed and over the counter). | 5 years | |
| Secondary | 4. Identification of potential research participants | The Charlson Comorbidity Index | 5 years | |
| Secondary | Prevalence of Comorbid conditions | the count of comorbidities | 5 years | |
| Secondary | Classification of Rheumatic Comorbid conditions | Rheumatic Disease Comorbidity Index (RDCI). | 5 years |