Investigating Musculoskeletal Health and Wellbeing

Investigating Musculoskeletal Health and Wellbeing: A Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Musculoskeletal Pain, Frailty, Disability
• Intervention / Treatment: Other: questionnaire

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Bonnie Millar; Phone Number: 0115 8231754; Email: bonnie.millar@nottingham.ac.uk

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG5 1PB
    • Recruiting
    • University of Nottingham
    • Contact: Bonnie Millar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Presence and prevalence of pain	Pain distribution will be recorded in a pain manikin.	5 years
Presence and prevalence of disability	Disability will be determined using the five Fried Criteria modified for questionnaire delivery.	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: David Walsh, University of Nottingham

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2018
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 18, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Frailty; Musculoskeletal Pain
• Other Study ID Numbers: 17113

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No