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NCT02820571 Clinical Trial

The Oxford Pain, Activity and Lifestyle (OPAL) Cohort Study

Low Back Pain Clinical Trial

— OPAL  

Official title:
The Oxford Pain, Activity and Lifestyle (OPAL) Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02820571
Other study ID # IRAS ID: 196643
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 4, 2016
Est. completion date March 2023

Study information
Verified date April 2021
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The OPAL study is about health outcomes in older adults. The investigators are surveying 4,000 adults across England to see how health and physical activity change over time. The information that is collected will help the investigators to understand how a person's health, including conditions such as back pain, affect their mobility as they age, and provide insight into improving the management of health in older adults.

Description:

The Oxford Pain, Activity and Lifestyle (OPAL) study is a large cohort study of community dwelling adults (n=4000) aged 65 years and over. This cohort data will allow the investigators to describe the prevalence, severity, course and prognosis a range of musculoskeletal problems in older people. The initial focus is to evaluate the impact of back pain on important health outcomes for older people (quality of life, mobility, falls and fractures). In order to do this, the investigators will study people with and without back pain at the inception of the cohort. The OPAL cohort will be followed for 5 years in the first instance and the investigators will study a range of factors hypothesised to moderate and mediate the effects of back and other musculoskeletal pain for example, co-morbidities. The OPAL cohort will be sampled from older people registered with primary care practices. The investigators aim to develop a prognostic tool using the cohort data that will help older people, GPs and other health professionals identify when LBP is a risk factor for disability, functional limitation and loss of mobility, and when LBP should be prioritised as a treatment target.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 5409
Est. completion date March 2023
Est. primary completion date March 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Registered with a primary care practice. - 65 years and over. Exclusion Criteria: - Living in a residential care or nursing home. - Has a terminal condition with a life expectancy of less than 6 months. - Any substantial health or social concern that, in the opinion of the patient's GP, would place the patient at increased risk or inability to participate including known inability to provide informed consent e.g. Dementia.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom University of Oxford, Botnar Research Centre Oxford Oxfordshire

Sponsors (1)
Lead Sponsor Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Lyle S, Williamson E, Darton F, Griffiths F, Lamb SE. A qualitative study of older people's experience of living with neurogenic claudication to inform the development of a physiotherapy intervention. Disabil Rehabil. 2017 May;39(10):1009-1017. doi: 10.1080/09638288.2016.1177611. Epub 2016 May 23. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Life-Space assessment Life-Space Assessment measures mobility in terms of the spatial extent of a person's life. The purpose of the Life-Space Assessment is to determine a person's usual pattern of mobility during the month preceding the assessment. Life-space is defined based upon the distance a person routinely travels to perform activities over this time frame. This includes determining how far and how often the person leaves his or her place of residence and the degree of independence the person has. 5 years
Primary Self-reported falls The investigators will use the definitions of the Prevention of Falls Network Europe consensus on core outcomes which provides standard definitions of falls. 5 years
Primary EQ-5D-5L Disability and health-related quality of life is measured by the EQ-5D-5L 5 years
Primary Tilburg Frailty Indicator 5 years
Primary Health Resource Use Health resource use will be captured through routine health service data collection systems (Hospital Episode Statistics: inpatient, accident and emergency and diagnostic imaging datasets). 5 years
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