Back PainNCT03474068
Characteristics of Back Pain Callers
An observational study of Back Pain, run by Teesside University.
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
- 7,120 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 contacting EMS.
Who may be able to join
- Patients having accessed EMS by contacting the North East Ambulance Service between 01-08-2016 and 31-07- 2017
- Aged 16 or over
- Initially coded as, or with a clinical impression of, non-traumatic back pain or cerebrovascular attack (CVA).
Who cannot join
- 1. Below the age of 16
About this study
Official title: An Investigation Into the Use of Emergency Medical Services by People 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 contacting EMS via telephone with non-traumatic back pain
- to describe the characteristics of people calling EMS with non-traumatic back pain
- to describe key characteristics of the contact between the service user and EMS
- to compare the call prevalence, patient characteristics and contact characteristics between people with non-traumatic back pain and a group of people for whom EMS contact is recommended as standard, in this case people presenting with cerebrovascular accident (CVA).
A secondary aim of the work is to explore what factors might predict patient outcomes such as whether the patient is transported to A/E, whether the patient receives analgesics, and whether the patient is admitted to hospital.
Read the detailed description
Purpose and Design
Back Pain is a common cause of chronic pain and disability. National Institute for Health and Clinical Excellence (NICE, 2016) identify it as affecting 1 in 10 people and causing more disability than any other condition. Whilst in most people it resolves without any healthcare input in can be distressing and debilitating. For those whose pain has not improved with non-steroidal anti-inflammatory drugs (NSAIDs) combined 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) however anecdotally many people with back pain self-refer to these services. 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 ambulance services.
This study aims to analyse anonymised data from the North East Ambulance Service NHS Trust (NEAS) to establish the prevalence of those calling with back pain. The characteristics of people presenting to the North East Ambulance Service (NEAS) over a 12-month period with back pain will be described and compared to a comparison group (people presenting with cardiovascular accident (CVA)) to identify statistically significant characteristics. The comparison group of CVA was chosen as this group is well defined, cannot be definitively treated in the community and require rapid transfer to in-patient care.
These characteristics may help target information and inform service design to meet those people with back pain not accessing specialist services that are more appropriate for their condition.
Research Methods
The study will request anonymised data from NEAS. The data will cover all people who have accessed their services in a 12-month period who were recorded as having: an initial presentation of back pain; a clinical impression of back pain; initial presentation of CVA; or clinical impression of CVA. The information include data related to the call or attendance, patient demographics, geographical location and clinical data.
Data will be analysed to establish descriptive statistics related to patients calling with back pain and comparing these to those with CVA.
Recruitment
The data being used for this study is from a currently existing NEAS database and therefore there will be no recruitment of participants.
Inclusion/exclusion All patients over the age of 16 will be included. Those aged under 16 will be excluded as they are not included in clinical guidelines.
All incidents that receive an initial coding or clinical impression of back pain or cerebrovascular accident will be included.
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 NEAS has confirmed that the data will be in non-personally identifiable 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 NEAS 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
Individual's data may be held in more than one system depending on their specific pathway of care and the best way to link these records is via the incident number. Before releasing the data NEAS will apply a mathematical function to all incident numbers, this will ensure they no longer be linked to individuals but records with the same incident number will still be linked. The nature of this function will be retained by NEAS and not disclosed to the research team.
The database contains socioeconomic data in the form of patients' postcodes. This socioeconomic data is important as it has been linked to ambulance service use. A postcode is identifiable data. To overcome this NEAS 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.
- Conditions
- Back Pain
- Keywords
- Emergency Medical Services, Stroke, Ambulances
- Medical subject headings
- Back Pain, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of people calling EMS via telephone with non-traumatic back pain.
Measured: 1 year
Age of people calling EMS with non-traumatic back pain.
Measured: 1 year
Gender of people calling EMS via telephone with non-traumatic back pain.
Measured: 1 year
Deprivation score of people calling EMS via telephone with non-traumatic back pain.
Measured: 1 year
Time of calls to EMS via telephone with non-traumatic back pain.
Measured: 1 year
Date of calls to EMS via telephone with non-traumatic back pain.
Measured: 1 year
Duration of patient care of patients with non-traumatic back pain attended by EMS.
Measured: 1 year
Drugs given to patients with non-traumatic back pain attended by EMS.
Measured: 1 year
Destination of patients with non-traumatic back pain attended by EMS.
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 posted22 Mar 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
- 7,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- North East Ambulance Service NHS Foundation Trust
- Responsible party
- Principal investigator, Matt Capsey, Teesside University
- Investigators
- Cormac Ryan, Principal investigator, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474068
- Sponsor's protocol ID
- 073/17
- Status last verified
- Nov 2018
- First submitted
- 8 Feb 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 With Back Pain
- ClinicalTrials.gov ID
- NCT03474068
- Acronym / sponsor ID
- 073/17
- Conditions
- Back Pain
- Keywords
- Emergency Medical Services, Stroke, Ambulances
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,120 participants (actual)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- North East Ambulance Service NHS Foundation Trust
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 22 Mar 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 contacting EMS via telephone with non-traumatic back pain
- to describe the characteristics of people calling EMS with non-traumatic back pain
- to describe key characteristics of the contact between the service user and EMS
- to compare the call prevalence, patient characteristics and contact characteristics between people with non-traumatic back pain and a group of people for whom EMS contact is recommended as standard, in this case people presenting with cerebrovascular accident (CVA).
A secondary aim of the work is to explore what factors might predict patient outcomes such as whether the patient is transported to A/E, whether the patient receives analgesics, and whether the patient is admitted to hospital.
Detailed description
Purpose and Design
Back Pain is a common cause of chronic pain and disability. National Institute for Health and Clinical Excellence (NICE, 2016) identify it as affecting 1 in 10 people and causing more disability than any other condition. Whilst in most people it resolves without any healthcare input in can be distressing and debilitating. For those whose pain has not improved with non-steroidal anti-inflammatory drugs (NSAIDs) combined 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) however anecdotally many people with back pain self-refer to these services. 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 ambulance services.
This study aims to analyse anonymised data from the North East Ambulance Service NHS Trust (NEAS) to establish the prevalence of those calling with back pain. The characteristics of people presenting to the North East Ambulance Service (NEAS) over a 12-month period with back pain will be described and compared to a comparison group (people presenting with cardiovascular accident (CVA)) to identify statistically significant characteristics. The comparison group of CVA was chosen as this group is well defined, cannot be definitively treated in the community and require rapid transfer to in-patient care.
These characteristics may help target information and inform service design to meet those people with back pain not accessing specialist services that are more appropriate for their condition.
Research Methods
The study will request anonymised data from NEAS. The data will cover all people who have accessed their services in a 12-month period who were recorded as having: an initial presentation of back pain; a clinical impression of back pain; initial presentation of CVA; or clinical impression of CVA. The information include data related to the call or attendance, patient demographics, geographical location and clinical data.
Data will be analysed to establish descriptive statistics related to patients calling with back pain and comparing these to those with CVA.
Recruitment
The data being used for this study is from a currently existing NEAS database and therefore there will be no recruitment of participants.
Inclusion/exclusion All patients over the age of 16 will be included. Those aged under 16 will be excluded as they are not included in clinical guidelines.
All incidents that receive an initial coding or clinical impression of back pain or cerebrovascular accident will be included.
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 NEAS has confirmed that the data will be in non-personally identifiable 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 NEAS 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
Individual's data may be held in more than one system depending on their specific pathway of care and the best way to link these records is via the incident number. Before releasing the data NEAS will apply a mathematical function to all incident numbers, this will ensure they no longer be linked to individuals but records with the same incident number will still be linked. The nature of this function will be retained by NEAS and not disclosed to the research team.
The database contains socioeconomic data in the form of patients' postcodes. This socioeconomic data is important as it has been linked to ambulance service use. A postcode is identifiable data. To overcome this NEAS 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.
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 contacting EMS.
Key inclusion criteria (3 listed)
- Patients having accessed EMS by contacting the North East Ambulance Service between 01-08-2016 and 31-07- 2017
- Aged 16 or over
- Initially coded as, or with a clinical impression of, non-traumatic back pain or cerebrovascular attack (CVA).
Key exclusion criteria (1 listed)
- 1. 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 calling EMS via telephone with non-traumatic back pain.
Time frame: 1 year
Age of people calling EMS with non-traumatic back pain.
Time frame: 1 year
Gender of people calling EMS via telephone with non-traumatic back pain.
Time frame: 1 year
Deprivation score of people calling EMS via telephone with non-traumatic back pain.
Time frame: 1 year
Time of calls to EMS via telephone with non-traumatic back pain.
Time frame: 1 year
Date of calls to EMS via telephone with non-traumatic back pain.
Time frame: 1 year
Duration of patient care of patients with non-traumatic back pain attended by EMS.
Time frame: 1 year
Drugs given to patients with non-traumatic back pain attended by EMS.
Time frame: 1 year
Destination of patients with non-traumatic back pain attended by EMS.
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 Teesside University.
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 3 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 calling EMS via telephone with non-traumatic back pain. (time frame: 1 year). The study lists 9 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.