Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000750785
Ethics application status
Approved
Date submitted
30/03/2022
Date registered
25/05/2022
Date last updated
14/06/2023
Date data sharing statement initially provided
25/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient-Reported Outcomes to Evaluate Three Pharmaceutical Grade Medicinal Cannabis Oils in Patients with Chronic Pain of Musculoskeletal Origin
Scientific title
Patient-Reported Outcomes to Evaluate Three Pharmaceutical Grade Medicinal Cannabis Oils in Patients with Chronic Pain of Musculoskeletal Origin
Secondary ID [1] 306761 0
MC MSK Pain Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain of musculoskeletal origin 325772 0
Condition category
Condition code
Musculoskeletal 323107 323107 0 0
Osteoarthritis
Musculoskeletal 323108 323108 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 323110 323110 0 0
Rheumatoid arthritis
Anaesthesiology 323111 323111 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This observational study aims to conclude whether one of three medications change or improve chronic pain originating from Musculoskeletal conditions, and other quality of life measures, as observed and reported by each participant's own experience. There will be 1 of 3 products, either Levin Health CBD+, Levin Health Balance, or Levin health THC+, that the Principal Investigator will choose to prescribe for each participant, according to clinical discretion. The treatment medication itself is an exposure that is beyond the scope of this study. Standardized and validated electronic, web-based Patient Reported Outcome Measures (PROMs) will be completed by 100 participants, using their own home computers or devices on a weekly basis, whilst they are using a pharmaceutical oral formulation of medicinal cannabis (MC) oil to treat Musculoskeletal (MSK) chronic pain. Measures will be compared with those taken at baseline. PROMs will take around 10-15 minutes per week to complete.
Any adverse events will also be reported and monitored via a PROM, as well as during study defined in-clinic or Telehealth consultations with the Principal Investigator, who is also a Medicinal Cannabis prescribing General Practitioner. The observed period will be 12-weeks, or until medication is ceased. The 3 different medications will not be compared to each other during data analysis.
Intervention code [1] 323212 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330879 0
Change in pain intensity and pain interference as a composite outcome, as reported via Patient Reported Outcome Measure (PROM) tools. Items in the Brief Pain Inventory Short Form, PROMIS® –57 Profile v2.1, and the Musculoskeletal Health Questionnaire (MSK-HQ) will be used to assess this.
Timepoint [1] 330879 0
PROMs collected at baseline, and then weekly for a 12 week period post-enrolment.
Secondary outcome [1] 407899 0
Incidence, frequency and severity of medication adverse events observation via TSQMII PROM and via clinic consultations. Adverse events may include:
Very common (affecting more than 1 in 10 people)
• feeling dizzy or tired
• feeling hungry
• problems with their memory or having trouble concentrating
• changed sense of taste or a dry mouth

Common (affecting less than 1 in 10 people)
• lack of energy or feeling weak or generally unwell
• problems with their memory or having trouble concentrating
• feeling abnormal or drunk
• feeling sleepy or drowsy
• blurred vision
• constipation or diarrhoea
• feeling nauseous or vomiting
• loss of balance or falling over
• feeling depressed or disorientated
• feeling over-excited or losing touch with reality
• difficulty speaking
• seeing or hearing things that are not there (hallucinations)

Uncommon (affecting less than 1 in 100 people)
• stomach pain
• delusional thoughts
• paranoid thoughts / feeling that other people are against them
• fast or irregular heartbeats, also called palpitations
• fainting
Timepoint [1] 407899 0
PROM collected on a weekly basis, for a 12 week period post-enrolment. Also, clinician reported data at 4 weeks, 8 weeks, and 12 weeks (observation termination) post-enrolment.
Secondary outcome [2] 407900 0
Change in anxiety and depression levels as a composite outcome, observed via Musculoskeletal Health Questionnaire (MSK-HQ) and PROMIS-57 Profile v2.1 PROMs.
Timepoint [2] 407900 0
PROMs collected at baseline, and then weekly for a 12 week period post-enrolment.
Secondary outcome [3] 407902 0
Change in fatigue and sleep quality as a composite outcome, observed via the Musculoskeletal Health Questionnaire (MSK-HQ) and PROMIS-57 Profile v2.1 PROMs.
Timepoint [3] 407902 0
PROMs collected at baseline, and then weekly for a 12 week period post-enrolment.
Secondary outcome [4] 407903 0
Other Quality of Life measure changes, reported via Musculoskeletal Health Questionnaire (MSK-HQ) and PROMIS-57 Prolfile v2.1, PROMs.
Timepoint [4] 407903 0
PROMs collected at baseline, and then weekly for a 12 week period post-enrolment.
Secondary outcome [5] 407904 0
Participant belief about the efficacy of the medication and their overall improvement. The Patients' Global Impression of Change (PGIC) scale PROM will be used at the conclusion of the study.
Timepoint [5] 407904 0
PROM collected at week 4, 8 and week 12 (observation termination) post-enrolment.
Secondary outcome [6] 421952 0
Changes in medication. A participant diary designed to record any changes in concomitant medications.
Timepoint [6] 421952 0
Changes in medication will be recorded daily by the participant

Eligibility
Key inclusion criteria
• Aged over 18 years
• A diagnosis of treatment resistant chronic pain of musculoskeletal origin
• Ability to give informed consent
• Willing and able to follow study instructions and likely to complete all PROM requirements via study website
• Able to provide informed consent
• Have a life-expectancy of >3 months
• Understand that there is a risk of prosecution if driving a car while under treatment
• Patient has been identified as eligible to receive medicinal cannabis under the TGA Special Access Scheme/Authorised by the Principal Investigator for chronic pain
• Participants must have been lawfully prescribed Levin Balance, Levin CBD+ or Levin THC+ by the Principal Investigator
• Participants agree to abstain from using another cannabis product other than their Levin Health product for the duration of their enrolment in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• have cognitive impairment
• are pregnant
• are unable to speak, read and/or write in English
• are unable to provide informed consent
• are unable to provide an email address
• have received prescription medicinal cannabis within the last 4 weeks
• are using illicit cannabis

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
1/06/2024
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
100
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311100 0
Commercial sector/Industry
Name [1] 311100 0
Levin Health Limited
Country [1] 311100 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Levin Health Limited
Address
Levin House
Carlow House
Suite 2-3, Level 6, 289 Flinders Lane
Melbourne, Victoria 3000
Country
Australia
Secondary sponsor category [1] 312480 0
None
Name [1] 312480 0
Address [1] 312480 0
Country [1] 312480 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310633 0
National Institute of Integrative Medicine Human Research Ethics Committee (EC00436)
Ethics committee address [1] 310633 0
National Institute of Integrative Medicine
11-23 Burwood Rd Hawthorn VIC 3122
Ethics committee country [1] 310633 0
Australia
Date submitted for ethics approval [1] 310633 0
08/11/2021
Approval date [1] 310633 0
04/04/2023
Ethics approval number [1] 310633 0
0095E_2021

Summary
Brief summary
The objective of this observational study is to examine whether there is a change or improvement in standardised and validated patient reported outcome measures, whilst using a standardized and pharmaceutical oral formulation of medicinal cannabis (MC) oil to treat Musculoskeletal (MSK) chronic pain over a 12-week period, or until they cease taking the medication. The study will also record any adverse outcomes that result whilst taking the medication. It is hoped conclusions will be drawn as to whether or not this particular medication warrants further and more rigorous clinical trial investigation as an interventional treatment for chronic pain, in this patient cohort.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118334 0
Dr Matthew Moore MD FAAFP FACRRM EM Cert
Address 118334 0
Mode Healthcare Pty Ltd
4/7 Clarke Street, Dunsborough WA 6281
Country 118334 0
Australia
Phone 118334 0
+61413 249 939
Fax 118334 0
Email 118334 0
matty@modehealthcare.com.au
Contact person for public queries
Name 118335 0
Mrs Sharlene Mavor
Address 118335 0
New Frontier Pty Ltd
Country 118335 0
Australia
Phone 118335 0
+61418939062
Fax 118335 0
Email 118335 0
sharlene@mavor.com.au
Contact person for scientific queries
Name 118336 0
Ms Rachel Jaros
Address 118336 0
New person handling scientific enquiries
Country 118336 0
Australia
Phone 118336 0
+61 435410750
Fax 118336 0
Email 118336 0
rachel.jaros@tsano.co

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data will not be available, only aggregate data will be available through peer-reviewed publications. The Sponsoring company will have access to raw data as it pertains to their medicinal cannabis product.


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
No additional documents have been identified.