Investigating Musculoskeletal Health and Wellbeing

Recruiting

• Conditions: Musculoskeletal Pain, Frailty, Disability

• Registration Number: NCT03696134
• Lead Sponsor: University of Nottingham

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-22
• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence, severity and prevalence of frailty, as measured by response to the study questionnaire at annual intervals	5 years	Frailty will be classified using the 5-item FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, \& Loss of Weight).
Presence and prevalence of disability	5 years	Disability will be determined using the five Fried Criteria modified for questionnaire delivery.
Presence and prevalence of pain	5 years	Pain distribution will be recorded in a pain manikin.

Secondary Outcome Measures

Name	Time	Method
1. Classification of phenotypic subgroups	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	5 years	Co-morbidities will be assessed using the Charlson Comorbidity Index
3. Medication usage	5 years	Participants will self-report their current medications (prescribed and over the counter).
4. Identification of potential research participants	5 years	The Charlson Comorbidity Index
Prevalence of Comorbid conditions	5 years	the count of comorbidities
Classification of Rheumatic Comorbid conditions	5 years	Rheumatic Disease Comorbidity Index (RDCI).

Trial Locations

Locations (1)

University of Nottingham; 🇬🇧 Nottingham, United Kingdom