NCT03474068

Brief 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. 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:

  1. 1.to quantify the prevalence of people contacting EMS via telephone with non-traumatic back pain
  2. 2.to describe the characteristics of people calling EMS with non-traumatic back pain
  3. 3.to describe key characteristics of the contact between the service user and EMS
  4. 4.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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,120

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

12 months

First QC Date

February 8, 2018

Last Update Submit

November 30, 2018

Conditions

Keywords

Emergency Medical Services, Stroke, Ambulances

Outcome Measures

Primary Outcomes (9)

  • Number of people calling EMS via telephone with non-traumatic back pain.

    1 year

  • Age of people calling EMS with non-traumatic back pain.

    1 year

  • Gender of people calling EMS via telephone with non-traumatic back pain.

    1 year

  • Deprivation score of people calling EMS via telephone with non-traumatic back pain.

    1 year

  • Time of calls to EMS via telephone with non-traumatic back pain.

    1 year

  • Date of calls to EMS via telephone with non-traumatic back pain.

    1 year

  • Duration of patient care of patients with non-traumatic back pain attended by EMS.

    1 year

  • Drugs given to patients with non-traumatic back pain attended by EMS.

    1 year

  • Destination of patients with non-traumatic back pain attended by EMS.

    1 year

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People contacting EMS.

You may qualify if:

  • 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).

You may not qualify if:

  • \. Below the age of 16

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Back PainStroke

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Cormac Ryan

    Teesside University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Paramedic Science

Study Record Dates

First Submitted

February 8, 2018

First Posted

March 22, 2018

Study Start

August 1, 2016

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

December 3, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share