Investigating Musculoskeletal Health and Wellbeing
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|ClinicalTrials.gov Identifier: NCT03696134|
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : October 4, 2018
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.
|Condition or disease||Intervention/treatment|
|Musculoskeletal Pain, Frailty, Disability||Other: questionnaire|
|Study Type :||Observational|
|Estimated Enrollment :||10000 participants|
|Official Title:||Investigating Musculoskeletal Health and Wellbeing: A Cohort Study|
|Actual Study Start Date :||June 22, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||April 30, 2023|
- Other: questionnaire
- 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.
- 1. Classification of phenotypic subgroups [ Time Frame: 5 years ]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).
- 2. Classification of comorbid conditions [ Time Frame: 5 years ]Co-morbidities will be assessed using the Charlson Comorbidity Index
- 3. Medication usage [ Time Frame: 5 years ]Participants will self-report their current medications (prescribed and over the counter).
- 4. Identification of potential research participants [ Time Frame: 5 years ]The Charlson Comorbidity Index
- Prevalence of Comorbid conditions [ Time Frame: 5 years ]the count of comorbidities
- Classification of Rheumatic Comorbid conditions [ Time Frame: 5 years ]Rheumatic Disease Comorbidity Index (RDCI).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696134
|Contact: Bonnie Millar||0115 firstname.lastname@example.org|
|University of Nottingham||Recruiting|
|Nottingham, United Kingdom, NG5 1PB|
|Contact: Bonnie Millar|
|Principal Investigator:||David Walsh||University of Nottingham|