Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001020976
Ethics application status
Approved
Date submitted
22/09/2011
Date registered
22/09/2011
Date last updated
15/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Steroids for Emergency Department Patients with Low Back Pain and Radiculopathy
Scientific title
The Effect of a Single Dose Intravenous Dexamethasone Compared to Placebo on Visual Analogue Pain Scores in Patients with Low Back Pain and Radiculopathy Presenting to the Emergency Department
Secondary ID [1] 263090 0
Nil
Secondary ID [2] 263091 0
Nil
Universal Trial Number (UTN)
U1111-1124-7197
Trial acronym
SEBRA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lumbosacral radiculopathy 270840 0
Condition category
Condition code
Musculoskeletal 271020 271020 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 271022 271022 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the treatment group, each participant will be given a single dose of 8 mg Dexamethasone diluted with 0.9% NaCl solution to 10ml total via intravenous route. They will be admitted for routine care in the observation ward of the emergency department until they meet discharge criteria. Routine care consists of a standardized regimen of regular analgesia (paracetamol+codeine, iburprofen, PRN Oxycodone) and physiotherapy referral/education. Discharge criteria include: mobilizing safely without assistance, tolerable pain levels, self-caring
Intervention code [1] 269439 0
Treatment: Drugs
Intervention code [2] 269440 0
Rehabilitation
Comparator / control treatment
In the control group, each participant will be given a dose of 10mL of 0.9% NaCl solution via intravenous route as placebo. The patient will then be admitted for routine care in the observation ward of the emergency department. Routine care consists of regular analgesia (paracetamol+codeine, ibuprofen, PRN endone) and physiotherapy referral/education.
Control group
Placebo

Outcomes
Primary outcome [1] 279681 0
Pain scores measured using a visual analogue scale.
Timepoint [1] 279681 0
Initial presentation to the emergency department,
at discharge, 24 hours and 6 weeks post intervention,
Secondary outcome [1] 294190 0
Oswestry Disability Index scores - This is the one of the most commonly used questionnaires for assessing disability in people with low back pain.
Timepoint [1] 294190 0
Initial presentation to the emergency department, at 24 hours and 6 weeks post intervention.
Secondary outcome [2] 294191 0
Length of stay in the Emergency Department (ED LOS) in hours
Timepoint [2] 294191 0
Measured from patient's arrival to triage (triage time) to the time the patient physically leaves the department (actual discharge)
Secondary outcome [3] 294192 0
Treatment time measured in hours
Timepoint [3] 294192 0
Time from being seen by doctor (time seen) to the time when the treating medical practitioner has deemed the patient safe for discharge which does not necessarily mean they have physically left the department (ready for discharge)
Secondary outcome [4] 294193 0
Time to return to normal activities - time it takes for the patient to return to normal daily activities at the level prior to their admission to the emergency department determined using a take-home or mail-out questionnaire and/or telephone follow up
Timepoint [4] 294193 0
Measured at 24 hours and at 6 weeks
Secondary outcome [5] 294194 0
Improvement in straight leg raise testing range of motion
Timepoint [5] 294194 0
Initial presentation and at discharge
Secondary outcome [6] 294195 0
Correlation between improvement in straight leg raise testing and functional disability scores
Timepoint [6] 294195 0
Measured at initial presentation, discharge and at 24 hours
Secondary outcome [7] 294196 0
Adverse effects of 8 mg intravenous Dexamethasone based on the self-report of the patient such as allergic reaction, nausea, and vomitting.
Timepoint [7] 294196 0
Duration of treatment in the emergency department, at 24 hours and at 6 weeks
Secondary outcome [8] 294197 0
Requirement of PRN Oxycodone in milligrams - assessed by the self report of the patient as to how many 5mg Oxycodone tablets he has taken in total
Timepoint [8] 294197 0
Duration of treatment in the emergency department, at 24 hours and at 6 weeks
Secondary outcome [9] 294198 0
Admission rates to in-patient hospital bed
Timepoint [9] 294198 0
Duration of treatment in the emergency department, at 24 hours and at 6 weeks

Eligibility
Key inclusion criteria
(1) Low back pain with radiculopathy – Defined as a history of a dermatomal distribution of pain, an increase in pain on coughing, sneezing, or straining, paroxysmal pain, and predominant leg pain

(2) Straight leg test positive - The straight leg raise test is deemed to be positive when there is reproduction of pain in the sciatic nerve distribution of the affected leg between 0 to 70 degrees, with the patient in the supine position with no pillow, a flat bed in 180 degrees horizontal, with the patient’s head and pelvis in the 180 degrees horizontal plane.

(3) Unable to mobilize safely without assistance
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Declines intravenous cannulation
(2) Below 18 or over 55
(3) People with intellectual or mental impairment
(4) Allergy to dexamethasone or NS
(5) Red flags: fever, history of malignancy, recent significant trauma, ectopic pregnancy
(6) Medical conditions were steroids are contraindicated or are being given (current asthma using oral steroids, body builders using anabolic steroids)
(7) History of lower back surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
At triage, potential participants will be flagged and an assessment of the patient will be conducted by a consultant, registrar, senior house officer or research assistant to determine their eligibility for the study. Consent will then be taken from the participants prior to randomization into test or control groups.

Patients are allocated to either treatment or control group using sequentially-numbered opaque sealed envelopes. Each SNOSE will have an allocation sequence printed on a 6x10cm paper, folded half three times, then placed in each SNOSE. Each included patient will receive a sequence number which corresponds with SNOSE allocation sequence.

The SNOSE are to be opened only by an independent nurse after a patient has been consented and ready for allocation to either control or treatment group to maintain allocation concealment.

The research assistant / treating doctor / bedside nurse will hand over the SNOSE to a nurse, independent of the study, who will be the only person allowed to read the instructions to either draw up the control drug (10ml of 0.9% NaCl) or experimental drug (8mg IV Dexamethasone diluted with 0.9% NaCl to 10ml total) in a syringe labelled with the corresponding sequence number. This syringe will then be given to the RA who will give the syringe to treating nurse or doctor who will administer the medication to the patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is done by independent statistician using 6 sets of blocks of 10, stratified for each hospital. The randomisation sequence will be transferred to sequentially-numbered opaque sealed envelopes (SNOSE). The code sequence is to be kept by an independent person. The allocation sequence is printed on a 6x10cm paper, folded half three times, then placed in individual SNOSE. Each included patient will receive a sequence number which corresponds with SNOSE allocation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4522 0
4226

Funding & Sponsors
Funding source category [1] 269913 0
Hospital
Name [1] 269913 0
Emergency Department - Gold Coast Health Service District
Country [1] 269913 0
Australia
Primary sponsor type
Individual
Name
Dr Gerben Keijzers
Address
Emergency Department - Gold Coast Hospital
108 Nerang St, Southport,
QLD 4215
Country
Australia
Secondary sponsor category [1] 268924 0
Individual
Name [1] 268924 0
Dr Siegfried Perez
Address [1] 268924 0
Emergency Department - Gold Coast Hospital
108 Nerang St, Southport,
QLD 4215
Country [1] 268924 0
Australia
Other collaborator category [1] 252266 0
Individual
Name [1] 252266 0
Mr Ravi Bala
Address [1] 252266 0
Emergency Department - Gold Coast Hospital
108 Nerang St, Southport,
QLD 4215
Country [1] 252266 0
Australia
Other collaborator category [2] 252267 0
Individual
Name [2] 252267 0
Ms Isabelle Horgan
Address [2] 252267 0
Emergency Department - Gold Coast Hospital
108 Nerang St, Southport,
QLD 4215
Country [2] 252267 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271881 0
Gold Coast Health Service District Humean Research Ethics Committee
Ethics committee address [1] 271881 0
Gold Coast Hospital
108 Nerang St, Southport,
QLD 4215
Ethics committee country [1] 271881 0
Australia
Date submitted for ethics approval [1] 271881 0
07/06/2011
Approval date [1] 271881 0
04/08/2011
Ethics approval number [1] 271881 0
HREC/11/QGC/68

Summary
Brief summary
Based on current medical literature, there are some suggestions that a single dose of steroid treatment may help improve back pain due to low back pain with radiculopathy. However, the research this has been based on has not been performed in the Emergency Department (ED), or do not necessarily measure important factors such as return to normal functioning, visual analogue pain scores or improvement in straight leg raise.

The aim of project is to measure and compare the effect of a single dose of intravenous steroid treatment (8 mg of Dexamethasone) versus a placebo (normal saline) on visual analogue pain scores. We are also trying to measure the time to return to normal functional level, improvement in straight leg raising and improvement in Oswestry Disability Index symptom scores. The overall aim is to make a recommendation regarding management of patients with acute back pain and radiculopathy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33191 0
Address 33191 0
Country 33191 0
Phone 33191 0
Fax 33191 0
Email 33191 0
Contact person for public queries
Name 16438 0
Dr Siegfried Perez
Address 16438 0
Emergency Department - Gold Coast Hospital
108 Nerang St, Southport,
QLD 4215
Country 16438 0
Australia
Phone 16438 0
+61755198211
Fax 16438 0
Email 16438 0
siegfriedperez@gmail.com
Contact person for scientific queries
Name 7366 0
Dr Siegfried Perez
Address 7366 0
Emergency Department - Gold Coast Hospital
108 Nerang St, Southport,
QLD 4215
Country 7366 0
Australia
Phone 7366 0
+61755198211
Fax 7366 0
Email 7366 0
siegfriedperez@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDoes a single dose of intravenous dexamethasone reduce Symptoms in Emergency department patients with low Back pain and RAdiculopathy (SEBRA)? A double-blind randomised controlled trial.2015https://dx.doi.org/10.1136/emermed-2013-203490
N.B. These documents automatically identified may not have been verified by the study sponsor.