Low Back PainOPALNCT02820571
The Oxford Pain, Activity and Lifestyle (OPAL) Cohort Study
An observational study of Low Back Pain, run by University of Oxford at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- How many people
- 5,409 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2016to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Participants in the OPAL cohort study will be community dwelling adults, aged 65 years and over, registered with a primary care practice
Who may be able to join
- Registered with a primary care practice.
- 65 years and over.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Oxford, Botnar Research Centre
Oxford, Oxfordshire, OX3 7LD
About this study
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.
Read the detailed 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.
- Conditions
- Low Back Pain
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
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.
Measured: 5 years
EQ-5D-5L
Disability and health-related quality of life is measured by the EQ-5D-5L
Measured: 5 years
Tilburg Frailty Indicator
Measured: 5 years
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).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start4 Oct 2016
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,409 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Lamb, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820571
- Sponsor's protocol ID
- IRAS ID: 196643
- Acronym
- OPAL
- Status last verified
- Apr 2021
- First submitted
- 23 Jun 2016
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27216498
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Oxford Pain, Activity and Lifestyle (OPAL) Cohort Study
- ClinicalTrials.gov ID
- NCT02820571
- Acronym / sponsor ID
- OPAL / IRAS ID: 196643
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,409 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 4 Oct 2016 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Participants in the OPAL cohort study will be community dwelling adults, aged 65 years and over, registered with a primary care practice
Key inclusion criteria (2 listed)
- Registered with a primary care practice.
- 65 years and over.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Life-Space assessment
Time frame: 5 years
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.
Self-reported falls
Time frame: 5 years
The investigators will use the definitions of the Prevention of Falls Network Europe consensus on core outcomes which provides standard definitions of falls.
EQ-5D-5L
Time frame: 5 years
Disability and health-related quality of life is measured by the EQ-5D-5L
Tilburg Frailty Indicator
Time frame: 5 years
Health Resource Use
Time frame: 5 years
Health resource use will be captured through routine health service data collection systems (Hospital Episode Statistics: inpatient, accident and emergency and diagnostic imaging datasets).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Background: PubMed 27216498Lyle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Lamb principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life-Space assessment (time frame: 5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820571, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.