ANZCTR - Registration

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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.

Scientific title

A randomized, double-blinded, placebo-controlled, clinical trial assessing the efficacy of CANnabidiol for reducing BACK pain in the emergency department (CANBACK)

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1210-8232

Trial acronym

CANBACK

Linked study record

Nil

Health condition

Health condition(s) or problem(s) studied:

Back pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Single dose oral syrup cannabidiol, 400mg, administered by nurse at the bedside.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Single dose oral caprylic/capric triglyceride syrup, administered by nurse at the bedside.

Control group

Placebo

Outcomes

Primary outcome [1]

The primary outcome measure will be the patients' pain score, determined using a verbal numerical pain scale, range 0-10.

Timepoint [1]

2 hours after study medication administration.

Secondary outcome [1]

ED length of stay as assessed by hospital electronic medical records.

Timepoint [1]

Up to 24 hours post admission to ED..

Secondary outcome [2]

Need for rescue analgesia as documented in hospital electronic medical records.

Timepoint [2]

Up to 24 hours post admission to ED.

Secondary outcome [3]

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%).

Timepoint [3]

48 hours post admission to ED.

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.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

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.

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)

Numbered containers.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software.

Masking / blinding

Blinded (masking used)

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

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Safety/efficacy

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.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/05/2018

Actual

Date of last participant enrolment

Anticipated

31/03/2019

Actual

Date of last data collection

Anticipated

2/04/2019

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Austin Medical Research Foundation

Address [1]

145 Studley Rd, Heidelberg VIC 3084

Country [1]

Australia

Funding source category [2]

Hospital

Name [2]

Austin Emergency Department, Austin Hospital

Address [2]

145 Studley Rd, Heidelberg VIC 3084

Country [2]

Australia

Primary sponsor type

Individual

Name

Dr Bronwyn Bebee

Address

Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Austin Hospital

Address [1]

145 Studley Rd, Heidelberg VIC 3084

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee (HREC)14

Ethics committee address [1]

145 Studley Road, Heidelberge VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/11/2017

Approval date [1]

30/11/2017

Ethics approval number [1]

HREC/17/Austin/430

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Bronwyn Bebee

Address

Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 5000

Fax

bronwyn.bebee@austin.org.au

Contact person for public queries

Name

Bronwyn Bebee

Address

Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 5000

Fax

bronwyn.bebee@austin.org.au

Contact person for scientific queries

Name

Bronwyn Bebee

Address

Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084

Country

Australia

Phone

+61 3 9496 5000

Fax

bronwyn.bebee@austin.org.au

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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Documents added manually

Documents added automatically