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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
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Study Description
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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.


Condition or disease Intervention/treatment
Musculoskeletal Pain, Frailty, Disability Other: questionnaire

Study Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Groups and Cohorts
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Intervention Details:
  • Other: questionnaire
    questionnaire

Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. Presence and prevalence of pain [ Time Frame: 5 years ]
    Pain distribution will be recorded in a pain manikin.

  3. Presence and prevalence of disability [ Time Frame: 5 years ]
    Disability will be determined using the five Fried Criteria modified for questionnaire delivery.


Secondary Outcome Measures :
  1. 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. 2. Classification of comorbid conditions [ Time Frame: 5 years ]
    Co-morbidities will be assessed using the Charlson Comorbidity Index

  3. 3. Medication usage [ Time Frame: 5 years ]
    Participants will self-report their current medications (prescribed and over the counter).

  4. 4. Identification of potential research participants [ Time Frame: 5 years ]
    The Charlson Comorbidity Index

  5. Prevalence of Comorbid conditions [ Time Frame: 5 years ]
    the count of comorbidities

  6. Classification of Rheumatic Comorbid conditions [ Time Frame: 5 years ]
    Rheumatic Disease Comorbidity Index (RDCI).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Bonnie Millar 0115 8231754 bonnie.millar@nottingham.ac.uk

Locations
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United Kingdom
University of Nottingham Recruiting
Nottingham, United Kingdom, NG5 1PB
Contact: Bonnie Millar         
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: David Walsh University of Nottingham
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03696134    
Other Study ID Numbers: 17113
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Pain
Frailty
Pathologic Processes
Muscular Diseases
 Musculoskeletal Diseases
Pain
Neurologic Manifestations