Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000554763p
Ethics application status
Not yet submitted
Date submitted
29/03/2022
Date registered
11/04/2022
Date last updated
11/04/2022
Date data sharing statement initially provided
11/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An Investigation of the effect of using a conformable and wearable ice pack on pain and discomfort following sacroiliac joint injection.
Scientific title
An Investigation into the efficacy of using a conformable and wearable ice pack on pain and analgesic use following sacroiliac joint injection
Secondary ID [1] 306644 0
Nil KNown
Universal Trial Number (UTN)
U1111-1275-5831
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanical Sacroiliac joint dysfunction 325568 0
Condition category
Condition code
Musculoskeletal 322942 322942 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible subjects will be provided with a wearable and conformable gel ice pack to use post injection to the sacroiliac joint The provision of the ice pack and instructions in its use will be provided by the principal investigator, an experienced SEM Physician. The instructions for use will be provided immediatley following the injection and subjects will begin using it at this time. Following 1 hour of use a 30 minute break will be undertaken and then it will be re-applied. The ice pack will be used in this manner up to 72 hours post injection. It will be removed for sleeping.
Intervention code [1] 323085 0
Treatment: Devices
Comparator / control treatment
The control group will be those who undergo similar injection but who will not be given the ice pack device.
Control group
Active

Outcomes
Primary outcome [1] 330708 0
Pain scores on Numerical Rating Scale (NRS)
Timepoint [1] 330708 0
Baseline pre -injection, immediatley after injection, and at 24 hours post injection
Secondary outcome [1] 407273 0
Analgesic use by recording of tablets taken and at what time by the particpants
Timepoint [1] 407273 0
Baseline pre -injection, immediatley after injection, and at 4,8,12 ,24, 48 ,72and 96 ,hours post injection

Eligibility
Key inclusion criteria
over age 18 and with the capacity to provide informed consent
Patients undergoing pre-determined sacroiliac joint injection
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to understand the Patient Consent and Information Form
Prior reaction to the use of cold therapies

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)
Allocation concealment will be observed. A sealed opaque enevlope system will be used
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
the randomisation allocation concelaed in the envelope.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power study has been performed and a minimum of 38 subjects in each arm will be required.

Statistical analysis will consist of Student t-test (for normally distributed data) or Median test (for skewed data) for continuous and analysis of variance (ANOVA) for categorical variables. If we have sufficient data (ie: 38 + 38 for each study group), a Poisson or Logistic regression model to determine the predictors of pain management with ice pack vs other analgesics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2022
Actual
Date of last participant enrolment
Anticipated
28/02/2023
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22062 0
Spine and Sportsmed - Meadowbank
Recruitment postcode(s) [1] 37032 0
2114 - Meadowbank
Recruitment postcode(s) [2] 37033 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 310969 0
Self funded/Unfunded
Name [1] 310969 0
A/Prof J Saunders
Country [1] 310969 0
Australia
Primary sponsor type
University
Name
Univeristy of Notre Dame Australia
Address
School of Medicine Sydney\Darlinghurst
160 Oxford St
Darlinghurst, NSW 2010

PO Box 944 Broadway 2007
Country
Australia
Secondary sponsor category [1] 312277 0
Commercial sector/Industry
Name [1] 312277 0
RE3 Australia
Address [1] 312277 0
6/34 Wirraway Dr, Port Melbourne VIC 3207
Attention Belinda Voight
Country [1] 312277 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 310527 0
The University of Notre Dame Australia Human Research Ethics Committee
Ethics committee address [1] 310527 0
Ethics committee country [1] 310527 0
Australia
Date submitted for ethics approval [1] 310527 0
29/04/2022
Approval date [1] 310527 0
Ethics approval number [1] 310527 0

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

Contacts
Principal investigator
Name 117966 0
A/Prof Jennifer Saunders
Address 117966 0
Spine and Sportsmed
Suite 101
5 Bay Drive
Meadowbank
NSW 2114
Country 117966 0
Australia
Phone 117966 0
+61 2 95875544
Fax 117966 0
+61 2 82115247
Email 117966 0
[email protected]
Contact person for public queries
Name 117967 0
Jennifer Saunders
Address 117967 0
Spine and Sportsmed
Suite 101
5 Bay Drive
Meadowbank
NSW 2114
Country 117967 0
Australia
Phone 117967 0
+61 2 95875544
Fax 117967 0
+61 2 82115247
Email 117967 0
[email protected]
Contact person for scientific queries
Name 117968 0
Jennifer Saunders
Address 117968 0
Spine and Sportsmed
Suite 101
5 Bay Drive
Meadowbank
NSW 2114
Country 117968 0
Australia
Phone 117968 0
+61 2 95875544
Fax 117968 0
+61 2 82115247
Email 117968 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all source data ( anonymised)
When will data be available (start and end dates)?
3 months after conclusion of data collection and concluding 5 years after data collection
Available to whom?
Researcher with an academic interest
Available for what types of analyses?
Any Purpose
How or where can data be obtained?
Data can be obtained by contacting the scientific contact previously named
[email protected]


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.