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Trial registered on ANZCTR
Registration number
ACTRN12618000487213
Ethics application status
Approved
Date submitted
15/03/2018
Date registered
4/04/2018
Date last updated
4/04/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
The CANBACK trial, to determine the efficacy of oral cannabidiol, when compared to placebo, as an adjunct for the treatment of acute non-traumatic low back pain.
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Scientific title
A randomized, double-blinded, placebo-controlled, clinical trial assessing the efficacy of CANnabidiol for reducing BACK pain in the emergency department (CANBACK)
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Secondary ID [1]
294314
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Nil known
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Universal Trial Number (UTN)
U1111-1210-8232
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Trial acronym
CANBACK
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Linked study record
Nil
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Health condition
Health condition(s) or problem(s) studied:
Back pain
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Condition category
Condition code
Musculoskeletal
306129
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Single dose oral syrup cannabidiol, 400mg, administered by nurse at the bedside.
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Intervention code [1]
300618
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Treatment: Drugs
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Comparator / control treatment
Single dose oral caprylic/capric triglyceride syrup, administered by nurse at the bedside.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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The primary outcome measure will be the patients' pain score, determined using a verbal numerical pain scale, range 0-10.
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Assessment method [1]
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Timepoint [1]
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2 hours after study medication administration.
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Secondary outcome [1]
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ED length of stay as assessed by hospital electronic medical records.
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Assessment method [1]
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Timepoint [1]
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Up to 24 hours post admission to ED..
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Secondary outcome [2]
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Need for rescue analgesia as documented in hospital electronic medical records.
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Assessment method [2]
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Timepoint [2]
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Up to 24 hours post admission to ED.
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Secondary outcome [3]
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Adverse events as documented on case sheet or reported by patient during 48 hour follow up phone call. Possible side effects include allergy, tiredness or lethargy (20-30%), diarrhea (10%), nausea or vomiting (10%), headache (10%).
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Assessment method [3]
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Timepoint [3]
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48 hours post admission to ED.
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Eligibility
Key inclusion criteria
Presentation with acute non-traumatic low back pain, defined as pain and discomfort localized below the costal margin and above the inferior gluteal folds for a period of less than 30 days as assessed by the treating physician. This definition will include those with a past history of low back pain.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- cannabis or cannabidiol use in previous 7 days, as reported by participant
- abnormal neurological examination
- fever (>37.6oC)
- a history of malignancy, non-musculoskeletal cause of back pain
- pregnancy - all female participants age < 60 will require a urine Beta hCG to exclude pregnancy.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
We believe that a clinically significant difference between the pain scores of the two groups at 2 hours after study medication administration would be 2 out of 10. In order to demonstrate a statistically significant difference between the groups at 2 hours, at least 47 patients are required in each group (mean pain scores in the placebo and CBD groups of 4 and 2, respectively, SD 3, alpha 0.05, 2-sided, power 0.9). As CBD has not previously been examined in the ED setting, a number of assumptions have been made in this calculation. Accordingly, we will enroll 50 patients in each study group.
The primary endpoint will be the difference in pain verbal numerical pain scores between the groups. The analysis will be conducted based on "intention to treat". Continuous variables will be summarized as median and interquartile ranges. The Mann Whitney U test will be used to analyse continuous unpaired continuous data. The Chi square test will be used to analyse unpaired categorical data.
SPSS for Windows statistical software (version 24.0, SPSS Inc., Chicago, Illinois, USA) will be employed for all analyses. Statistical significance will be recognized at 0.05.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/05/2018
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Actual
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Date of last participant enrolment
Anticipated
31/03/2019
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Actual
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Date of last data collection
Anticipated
2/04/2019
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
22047
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Austin Medical Research Foundation
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Address [1]
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145 Studley Rd, Heidelberg VIC 3084
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Country [1]
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Australia
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Funding source category [2]
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Hospital
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Name [2]
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Austin Emergency Department, Austin Hospital
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Address [2]
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145 Studley Rd, Heidelberg VIC 3084
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Country [2]
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Australia
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Primary sponsor type
Individual
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Name
Dr Bronwyn Bebee
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Address
Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
298176
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Austin Hospital
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Address [1]
298176
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145 Studley Rd, Heidelberg VIC 3084
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Country [1]
298176
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299894
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Austin Health Human Research Ethics Committee (HREC)14
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Ethics committee address [1]
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145 Studley Road, Heidelberge VIC 3084
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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09/11/2017
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Approval date [1]
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30/11/2017
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Ethics approval number [1]
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HREC/17/Austin/430
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Summary
Brief summary
Acute, non-traumatic, low back pain is one of the most common musculoskeletal complaints worldwide and affects people of all ages. Although the majority of these individuals present to a primary care provider for assessment and management of their pain, a large proportion present to the emergency department (ED), especially when conventional analgesia is not working. Research suggests that low back pain is one of the leading causes of ED visits worldwide. While simple analgesics, opioids and muscle relaxants are commonly used to provide relief, there is little evidence to support the efficacy of these treatments. Accordingly, the management of acute low back pain in the ED represents a real challenge to clinicians.
Cannabidiol (CBD), a major non-psychotropic constituent of Cannabis, has pharmacological actions as an anxiolytic, antipsychotic, antiemetic and anti-inflammatory. There are data indicating that CBD and its analogues may be beneficial for pain resulting from inflammation. In addition, CBD has considerable efficacy in managing the pain and spasm of patients with multiple sclerosis. Despite these data, no randomized, placebo-controlled trials have been undertaken to assess the utility of CBD for the treatment of acute back pain.
In this study, patients presenting to the Austin ED with a diagnosis of acute (or acute-on-chronic), non-traumatic, low back pain will be randomized to either a single dose of CBD or placebo. This will be as an adjunct to the standard ED medication regimen for this condition. A verbal numerical pain scale (range 0-10) will be used to record pain scores at triage and at 0, 30, 60 and 120 minutes post study drug administration and at ED discharge. Patients may be admitted to the short stay unit during their stay.
We hypothesize that, among patients presenting to the ED with acute, non-traumatic, low back pain, a single dose of oral CBD will result in lower pain scores on the VAS at 2 hours, with minimal adverse effects, as compared to placebo.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Bronwyn Bebee
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Address
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Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084
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Country
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Australia
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Phone
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+61 3 9496 5000
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Fax
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Email
81898
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[email protected]
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Contact person for public queries
Name
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Dr Bronwyn Bebee
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Address
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Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084
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Country
81899
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Australia
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Phone
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+61 3 9496 5000
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Fax
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Email
81899
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[email protected]
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Contact person for scientific queries
Name
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Dr Bronwyn Bebee
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Address
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Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084
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Country
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Australia
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Phone
81900
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+61 3 9496 5000
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Fax
81900
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Email
81900
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
The CANBACK trial: a randomised, controlled clinical trial of oral cannabidiol for people presenting to the emergency department with acute low back pain.
2021
https://dx.doi.org/10.5694/mja2.51014
N.B. These documents automatically identified may not have been verified by the study sponsor.
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