Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000721505p
Ethics application status
Submitted, not yet approved
Date submitted
28/05/2024
Date registered
12/06/2024
Date last updated
12/06/2024
Date data sharing statement initially provided
12/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of cannabidiol (CBD) on muscle recovery and pain in healthy males.
Scientific title
The effect of cannabidiol (CBD) on recovery of muscle function, muscle activation and pain following contusion injury in healthy males
Secondary ID [1] 312232 0
NIL known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contusion injury 333933 0
Soft tissue injury 333934 0
Condition category
Condition code
Musculoskeletal 330604 330604 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 330605 330605 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 330606 330606 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following baseline measures of muscle function, activation and pain, participants will be asked to lie on a padded bed with one leg outstretched. Using a previously established method to induce a contusion injury, a custom-made implement, weighing 7.2kg, will be dropped once down a guide tube from 67cm onto the contracted vastus lateralis (lateral side of the thigh) of one leg. Taking less than half a second, this impact has been shown to produce a force similar to that occurring in contact sports and induces a change in muscle function, soreness and swelling for up to 72-hours after impact.

Measures of muscle function, activation and pain will be repeated 30 minutes after injury, after which participants will take 1mL of CBD oil or the placebo (medium triglyceride (MCT) oil) sublingually. The treatment will be taken three times daily (morning, midday and evening) over the following three days - up to 72 hours post injury. Each 1mL of CBD oil will provide 120mg of CBD. Participants will be asked to bring the dropper bottle to each visit (24, 48 and 72 hours) so that the volume can be monitored for adherence. Participants will also be asked to report the number of times they took the oil each day.

At least two-weeks after the last measures are made for the first trial, the same procedures will be repeated using the other leg and treatment.
Intervention code [1] 328683 0
Treatment: Drugs
Intervention code [2] 328684 0
Rehabilitation
Intervention code [3] 328685 0
Lifestyle
Comparator / control treatment
Participants will take 1ml of MCT oil sublingually immediately after injury and then three times daily (morning, midday and evening) for three days.
Control group
Placebo

Outcomes
Primary outcome [1] 338352 0
Muscle function
Timepoint [1] 338352 0
Pre-injury, 30 minutes post-injury and 24, 48 and 72 hours post-injury
Primary outcome [2] 338353 0
Muscle soreness
Timepoint [2] 338353 0
Pre-injury, 30 minutes post-injury, 24, 48 and 72 hours post-injury
Primary outcome [3] 338354 0
Muscle activation
Timepoint [3] 338354 0
Pre-injury, 30 minutes post-injury and 24, 48 and 72 hours post-injury.
Secondary outcome [1] 435582 0
Swelling
Timepoint [1] 435582 0
Pre-injury, 30 minutes post-injury and 24, 48 and 72 hours post-injury
Secondary outcome [2] 435583 0
Sleep quality and quantity (composite outcome)
Timepoint [2] 435583 0
Three nights prior to injury and three nights during each trial (night of injury, and two subsequent nights after injury).
Secondary outcome [3] 435584 0
Injury related complications
Timepoint [3] 435584 0
24 hours post-injury
Secondary outcome [4] 436016 0
Pressure pain threshold test
Timepoint [4] 436016 0
Pre-injury, 30 minutes, 24, 48 and 72 hours post injury.

Eligibility
Key inclusion criteria
Healthy males, aged 18-40 years, who have previously experienced a contusion injury without complication.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
• do not have the normal genotype for CBD metabolism
• have any current or previous injury to your legs
• have had an injury or medical condition that you think may affect your ability to sense pain or discomfort
• are taking prescribed medication that may alter your recovery to contusion injury
• are taking prescribed medication that may be altered by taking CBD
• have an illness that affects your liver
• have any disorder of bleeding or clotting of the blood
• have any family history of a bleeding disorder such as von Willebrand disease or haemophilia
• have had excessive bleeding from trivial wounds that lasted more than 15 minutes or that was recurring spontaneously during the 7 days after the injury
• have had a history of prolonged bleeding after a surgical procedure or dental extraction
• have had bruising with no apparent or minimal trauma, especially if a lump was felt with the bruise
• have had spontaneous nose bleeds that last more than 10 minutes or that required medical attention
• have had blood in your stool that was unexplained by diagnosis of a specific condition (eg. Stomach ulcer, polyp in the colon etc) that needed medical attention
• have a history of anaemia requiring treatment
• have received a blood transfusion
• have experienced medical complications as a result of soft tissue/contusion injury in the past
• have current bruising to the intended site of contusion

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)
Treatments will be provided to the researcher by the manufacturer in opaque dropper bottles labeled A or B. The contents of the bottles will be revealed once data has been collected and analysed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To date, the effects of CBD on contusion injury have not been investigated, and therefore it is unclear how many participants will be needed to identify whether there is a beneficial effect. Therefore, a power analysis for a repeated measures design was performed in G*Power software version 3.1.97 using effect sizes from an exercise-based trial. Based on effect sizes (d = 0.37) reported by Isenmann et al. (2022), for effects of CBD on recovery from muscle damaging exercise, and power = 0.80 and alpha = 0.05, a sample size of n = 12 was determined.
Additionally, using eight participants, Barnes et al. (2022) found large effect sizes for pain, loss of muscle function and swelling in response to the experimental model of contusion injury that will be used in this study.
Data will be analysed using a two way repeated measures ANOVA to identify differences between treatments over time. Where a significant main or interaction effect is found, post hoc analysis will be performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
19/12/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 26346 0
New Zealand
State/province [1] 26346 0
Manawatu

Funding & Sponsors
Funding source category [1] 316609 0
Commercial sector/Industry
Name [1] 316609 0
Eqalis Pharmacueticals Ltd
Country [1] 316609 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Country
New Zealand
Secondary sponsor category [1] 318793 0
None
Name [1] 318793 0
Address [1] 318793 0
Country [1] 318793 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315395 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 315395 0
Ethics committee country [1] 315395 0
New Zealand
Date submitted for ethics approval [1] 315395 0
26/03/2024
Approval date [1] 315395 0
Ethics approval number [1] 315395 0
2024 FULL 17987

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134566 0
A/Prof Matthew J Barnes
Address 134566 0
Massey University, Private Bag 11222, Palmerston North 4410
Country 134566 0
New Zealand
Phone 134566 0
+64 69516822
Fax 134566 0
Email 134566 0
[email protected]
Contact person for public queries
Name 134567 0
Matthew J Barnes
Address 134567 0
Massey University, Private Bag 11222, Palmerston North 4410
Country 134567 0
New Zealand
Phone 134567 0
+64 69516822
Fax 134567 0
Email 134567 0
[email protected]
Contact person for scientific queries
Name 134568 0
Matthew J Barnes
Address 134568 0
Massey University, Private Bag 11222, Palmerston North 4410
Country 134568 0
New Zealand
Phone 134568 0
+64 69516822
Fax 134568 0
Email 134568 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be analysed and published as means and standard deviations. No individual data will be made available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23788Study protocol  [email protected] Contact lead researcher
23789Informed consent form  [email protected] Contact lead researcher
23790Ethical approval  [email protected] Contact lead researcher



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.