Back PainNCT03762174
Characteristics of Back Pain Attendances at ED
An observational study of Back Pain, run by Matt Capsey.
Trial summary
Back pain is experienced by approximately 80% of the population during their life. However, only a small minority (<1%) will have a medical condition (such as Cauda Equina Syndrome) which requires immediate medical intervention. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- How many people
- 62,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 31 Jul 2017
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: People attending ED
Who may be able to join
- Patients who have attended Darlington Memorial Hospital between 01-08-2016 and 31-07-2017
- Aged 16 or over
Who cannot join
- Below the age of 16
About this study
Official title: An Investigation Into the Use of Emergency Medical Services by People Attending the Emergency Department With Back Pain
Back pain is experienced by approximately 80% of the population during their life. However, only a small minority (<1%) will have a medical condition (such as Cauda Equina Syndrome) which requires immediate medical intervention.
Currently, it is not known how many people access Emergency Medical Services (EMS) in an attempt to meet their needs for their back pain. The demand on EMS is increasing and many of these patients could be better managed by other services. Additionally, little is known about the characteristics of those accessing EMS due to back pain, or the nature of the contacts regarding issues such as outcome of the patient contact. The aims of this study are:
Read more
- to quantify the prevalence of people accessing EMS via attendance at an Emergency Department (ED)
- to describe the characteristics of people attending ED with non-traumatic back pain
- to describe key characteristics of the contact between the service user and EMS
- to compare the prevalence of attendance, patient characteristics and contact characteristics between people with non-traumatic back pain and the general population of those attending ED.
A secondary aim of the work is to explore what factors might predict patient outcomes such as whether the patient self presents or is referred to ED by another service, whether the patient receives analgesics, whether the patient receives a diagnostic scan and whether the patient is admitted to hospital.
Read the detailed description
Purpose and Design
Back Pain is a common cause of pain and disability. The National Institute for Clinical Excellent [NICE] (2016) identify back pain as affecting 1 in 10 people and causing more disability than any other condition. In most people back pain resolves within a number of weeks without any healthcare input. For those whose pain does not improve physical and psychological treatments are recommended. These are provided by specialist services and are not available in Emergency Departments or via Ambulance Services (collectively referred to as Emergency Medical Services [EMS]). Thus, arguably only a very small minority of patients with back pain, where a severe medical pathology is indicated (e.g. cauda equina syndrome) should need to access EMS. However, anecdotally many people with back pain self-refer to EMS. The prevalence of people self-referring and their characteristics are currently unknown as these figures are not routinely reported although the information exists within the data collected by many trusts.
This study aims to analyse anonymised data from the Darlington Memorial Hospital (DMH) Emergency Department (ED) to establish the prevalence of those attending with back pain. The characteristics of people presenting over a 12-month period with back pain, along with characteristics of their contact (e.g.
administration of analgesia and the use of diagnostic imaging) will be described and compared to the general characteristics of those attending ED.
These characteristics may help to inform healthcare service design, both EMS and non-EMS, to better meet the needs of this patient group.
Research Methods
This study will be a secondary analysis of an existing NHS database. The study will request anonymised data from DMH ED. The data will cover all adults who have accessed their services in a 12-month period. The information requested will include data related to the attendance, patient demographics/characteristics, geographical location and clinical data.
Recruitment
The data being used for this study is from a currently existing Trust database and therefore there will be no recruitment of participants.
Inclusion/exclusion All individuals over the age of 16 will be included. Those aged under 16 will be excluded as they are not included in clinical guidelines.
Risks, Burdens and Benefits
The data has been collected for clinical care and not for research purposes. Therefore patients will not have explicitly consented for their information to be used for research. The Information Governance Officer at DMH has confirmed that the data will be in non-personally identifiable form when it is released to the research team and is compliant with Section 33 of the Data Protection Act 1998.
The main risk to patients is that their clinical data is being used for research purposes. However identifiable data will only be available to the usual clinical team. Anonymised information will be extracted by a DMH member of staff before it is securely transferred to the team at Teesside University where it will be analysed. Names and addresses will be completely removed from the database before it leaves the NHS.
Some publications require raw data to be supplied. This would be supplied but it will be a non-personally identifiable dataset.
Confidentiality
The Caldicott Principles will be followed:
- Justify the purpose(s) of obtaining the information
- Don't use person-identifiable information unless it is absolutely necessary
- Use the minimum necessary person-identifiable information
- Access to person-identifiable information should be on a strict need-to-know basis
- Everyone with access to person-identifiable information should be aware of their responsibilities
- Understand and comply with the law
Problems arising from the processing of identifiable data and how they will be handled
The database contains socioeconomic data in the form of patients' postcodes. This socioeconomic data is important as it has been linked to emergency medical service use. A postcode is identifiable data. To overcome this DMH will supply only the first four digits which covers a sufficiently large geographical area that this will no longer be identifiable data. The first four digits will be sufficient to identify a Lower Layer Super Output Area code (LSOA code) which is the equivalent index of socioeconomic status.
As the dataset will include all adults attending ED it will inevitably include members of vulnerable groups or others who would usually require additional ethical approval for inclusion in research (for example offenders) however this will not be known to the research team or be apparent in the non-personally identifiable data requested.
- Conditions
- Back Pain
- Keywords
- Emergency Medical Services, Emergency Department, Back Pain
- Medical subject headings
- Back Pain, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of people attending ED with back pain
Measured: 1 year
Age of people attending ED with back pain
Measured: 1 year
Gender of people attending ED with back pain
Measured: 1 year
Deprivation score of people attending ED with back pain
Measured: 1 year
Time of attendance of people attending ED with back pain
Measured: 1 year
Date of attendance of people attending ED with back pain
Measured: 1 year
Duration of attendance of people attending ED with back pain
Measured: 1 year
Drugs given to people attending ED with back pain
Measured: 1 year
Diagnostic tests used with people attending ED with back pain
Measured: 1 year
Disposal of people attending ED with back pain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 Aug 2016
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 62,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matt Capsey
- Sponsor type
- University, hospital or other
- Collaborators
- County Durham and Darlington NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Matt Capsey, Teesside University
- Investigators
- Cormac Ryan, Principal investigator, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762174
- Sponsor's protocol ID
- 147/17
- Status last verified
- Nov 2018
- First submitted
- 30 Nov 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Use of Emergency Medical Services by People Attending the Emergency Department With Back Pain
- ClinicalTrials.gov ID
- NCT03762174
- Acronym / sponsor ID
- 147/17
- Conditions
- Back Pain
- Keywords
- Emergency Medical Services, Emergency Department, Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62,000 participants (actual)
- Lead sponsor
- Matt CapseyUniversity, hospital or other
- Collaborators
- County Durham and Darlington NHS Foundation Trust
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 3 Dec 2018 (actual)
- 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.
Back pain is experienced by approximately 80% of the population during their life. However, only a small minority (<1%) will have a medical condition (such as Cauda Equina Syndrome) which requires immediate medical intervention.
Currently, it is not known how many people access Emergency Medical Services (EMS) in an attempt to meet their needs for their back pain. The demand on EMS is increasing and many of these patients could be better managed by other services. Additionally, little is known about the characteristics of those accessing EMS due to back pain, or the nature of the contacts regarding issues such as outcome of the patient contact. The aims of this study are:
- to quantify the prevalence of people accessing EMS via attendance at an Emergency Department (ED)
- to describe the characteristics of people attending ED with non-traumatic back pain
- to describe key characteristics of the contact between the service user and EMS
- to compare the prevalence of attendance, patient characteristics and contact characteristics between people with non-traumatic back pain and the general population of those attending ED.
A secondary aim of the work is to explore what factors might predict patient outcomes such as whether the patient self presents or is referred to ED by another service, whether the patient receives analgesics, whether the patient receives a diagnostic scan and whether the patient is admitted to hospital.
Detailed description
Purpose and Design
Back Pain is a common cause of pain and disability. The National Institute for Clinical Excellent [NICE] (2016) identify back pain as affecting 1 in 10 people and causing more disability than any other condition. In most people back pain resolves within a number of weeks without any healthcare input. For those whose pain does not improve physical and psychological treatments are recommended. These are provided by specialist services and are not available in Emergency Departments or via Ambulance Services (collectively referred to as Emergency Medical Services [EMS]). Thus, arguably only a very small minority of patients with back pain, where a severe medical pathology is indicated (e.g. cauda equina syndrome) should need to access EMS. However, anecdotally many people with back pain self-refer to EMS. The prevalence of people self-referring and their characteristics are currently unknown as these figures are not routinely reported although the information exists within the data collected by many trusts.
This study aims to analyse anonymised data from the Darlington Memorial Hospital (DMH) Emergency Department (ED) to establish the prevalence of those attending with back pain. The characteristics of people presenting over a 12-month period with back pain, along with characteristics of their contact (e.g.
administration of analgesia and the use of diagnostic imaging) will be described and compared to the general characteristics of those attending ED.
These characteristics may help to inform healthcare service design, both EMS and non-EMS, to better meet the needs of this patient group.
Research Methods
This study will be a secondary analysis of an existing NHS database. The study will request anonymised data from DMH ED. The data will cover all adults who have accessed their services in a 12-month period. The information requested will include data related to the attendance, patient demographics/characteristics, geographical location and clinical data.
Recruitment
The data being used for this study is from a currently existing Trust database and therefore there will be no recruitment of participants.
Inclusion/exclusion All individuals over the age of 16 will be included. Those aged under 16 will be excluded as they are not included in clinical guidelines.
Risks, Burdens and Benefits
The data has been collected for clinical care and not for research purposes. Therefore patients will not have explicitly consented for their information to be used for research. The Information Governance Officer at DMH has confirmed that the data will be in non-personally identifiable form when it is released to the research team and is compliant with Section 33 of the Data Protection Act 1998.
The main risk to patients is that their clinical data is being used for research purposes. However identifiable data will only be available to the usual clinical team. Anonymised information will be extracted by a DMH member of staff before it is securely transferred to the team at Teesside University where it will be analysed. Names and addresses will be completely removed from the database before it leaves the NHS.
Some publications require raw data to be supplied. This would be supplied but it will be a non-personally identifiable dataset.
Confidentiality
The Caldicott Principles will be followed:
- Justify the purpose(s) of obtaining the information
- Don't use person-identifiable information unless it is absolutely necessary
- Use the minimum necessary person-identifiable information
- Access to person-identifiable information should be on a strict need-to-know basis
- Everyone with access to person-identifiable information should be aware of their responsibilities
- Understand and comply with the law
Problems arising from the processing of identifiable data and how they will be handled
The database contains socioeconomic data in the form of patients' postcodes. This socioeconomic data is important as it has been linked to emergency medical service use. A postcode is identifiable data. To overcome this DMH will supply only the first four digits which covers a sufficiently large geographical area that this will no longer be identifiable data. The first four digits will be sufficient to identify a Lower Layer Super Output Area code (LSOA code) which is the equivalent index of socioeconomic status.
As the dataset will include all adults attending ED it will inevitably include members of vulnerable groups or others who would usually require additional ethical approval for inclusion in research (for example offenders) however this will not be known to the research team or be apparent in the non-personally identifiable data requested.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People attending ED
Key inclusion criteria (2 listed)
- Patients who have attended Darlington Memorial Hospital between 01-08-2016 and 31-07-2017
- Aged 16 or over
Key exclusion criteria (1 listed)
- Below the age of 16
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
Number of people attending ED with back pain
Time frame: 1 year
Age of people attending ED with back pain
Time frame: 1 year
Gender of people attending ED with back pain
Time frame: 1 year
Deprivation score of people attending ED with back pain
Time frame: 1 year
Time of attendance of people attending ED with back pain
Time frame: 1 year
Date of attendance of people attending ED with back pain
Time frame: 1 year
Duration of attendance of people attending ED with back pain
Time frame: 1 year
Drugs given to people attending ED with back pain
Time frame: 1 year
Diagnostic tests used with people attending ED with back pain
Time frame: 1 year
Disposal of people attending ED with back pain
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Cormac Ryan principal investigator
Teesside University
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain, run by Matt Capsey.
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 1 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: finished, as of the sponsor's last update on 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of people attending ED with back pain (time frame: 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2018.