Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000270213
Ethics application status
Approved
Date submitted
1/02/2018
Date registered
21/02/2018
Date last updated
4/02/2019
Date data sharing statement initially provided
4/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Heat wrap therapy for the management of acute low back pain
Scientific title
Heat wrap therapy for the management of acute low back pain: a feasibility study.
Secondary ID [1] 293937 0
None
Universal Trial Number (UTN)
Trial acronym
HEAT pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 306422 0
Condition category
Condition code
Musculoskeletal 305509 305509 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Heat wrap. The patches we are testing, FlexEze heat patches, are an external heat source that provide up to 12 hours low-level continuous heat. The patches are inserted in a pouch i.e. body wrap) that holds them in place against the low back area and allows the person to move around with the heat patch in place. The heat patches contain iron powder, charcoal and salt (natural ingredients) and are air-activated. They are designed to warm gradually and reach maximum heat (~51oC) in 30 minutes. The patches do not contain any topically (or systemically) applied/delivered medicines/ substances/rubefacients and are a TGA registered product (Australian Register of Therapeutic Goods (ARTG) # 209075 – Medical Devices Class IIa, i.e. low-medium risk device/product).

The participants will wear the heat wrap during waking hours for up to 7 consecutive days. They will be encouraged to have a 1-day break in the middle to avoid the possibility of skin irritation.

We will monitor adherence to the intervention from the participants' pain and intervention diary, which they will be asked to complete over the course of the trial.
Intervention code [1] 300200 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304642 0
Clinician perspectives on the feasibility and acceptability of heat wrap therapy for the management of acute LBP in primary care. This will be determined using semi-structured interviews.
Timepoint [1] 304642 0
1 week post commencement of heat wrap therapy
Primary outcome [2] 304760 0
Patient perspectives on the feasibility and acceptability of heat wrap therapy for the management of acute LBP in primary care. This will be determined using semi-structured interviews.
Timepoint [2] 304760 0
Single interview carried out at least one and up to 8 weeks post intervention
Secondary outcome [1] 342655 0
Evaluate the feasibility of proposed outcome measures. In order to determine the feasibility of proposed outcome measures we will look at both the results from the Research Burden Questionnaire and also consider whether there were any missing data, particularly for our clinical outcomes. The Research Burden Questionnaire we are using is an adapted version of the Treatment Satisfaction Questionnaire for Medications (Version 1).
Timepoint [1] 342655 0
1 month post commencement of heat wrap therapy. This will be determined through semi-structured interviews and a short questionnaire about the research burden of the study.
Secondary outcome [2] 343022 0
Evaluate the feasibility of planned recruitment methods. This will be determined through semi-structured interviews and a short questionnaire about the research burden of the study. Both clinicians and participants will be interviewed for their thoughts about the feasibility of the recruitment strategies used in this study. The interview scripts have been developed specifically for this trial.
We have used an adapted version of the Treatment Satisfaction Questionnaire for Medications (Version 1) to determine Research Burden. This questionnaire will be administered to patients.
Timepoint [2] 343022 0
One month post commencement of heat wrap therapy

Eligibility
Key inclusion criteria
Adult patients with acute non-specific LBP (pain duration <3 months) of at least moderate intensity (greater than or equal to 4/10 on a 11-point pain rating scale) and have not previously tried heat wrap therapy for their LBP
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
children and adolescents (less than 18 years old), adults with suspected serious spinal pathology, those scheduled for back surgery or who had back surgery in the preceding 6 months, pregnant or breast feeding women, those with insufficient understanding of the English language, or who have a skin, sensory, cognitive or neurological condition where continuous application of heat would be contraindicated or problematic.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/02/2018
Actual
26/07/2018
Date of last participant enrolment
Anticipated
20/12/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298564 0
Other Collaborative groups
Name [1] 298564 0
Sydney Musculoskeletal Bone and Joint Health Alliance
Country [1] 298564 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 297712 0
None
Name [1] 297712 0
Address [1] 297712 0
Country [1] 297712 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299531 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 299531 0
Camperdown NSW 2006
Ethics committee country [1] 299531 0
Australia
Date submitted for ethics approval [1] 299531 0
17/09/2017
Approval date [1] 299531 0
30/01/2018
Ethics approval number [1] 299531 0

Summary
Brief summary
The current study is a prospective cohort study that will test the feasibility and acceptability of heat wrap therapy as well as our ability to collect the key outcomes planned for the RCT, which are use of analgesic medications, clinical outcomes (such as pain, function), and adverse events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80746 0
Dr Christina Abdel Shaheed
Address 80746 0
Level 10 North, King George V Building, Royal Prince Alfred Hospital (C39)
PO Box 179, Missenden Road NSW 2050
Country 80746 0
Australia
Phone 80746 0
+61 2 8627 6236
Fax 80746 0
Email 80746 0
Christina.Abdelshaheed@sydney.edu.au
Contact person for public queries
Name 80747 0
Dr Christina Abdel Shaheed
Address 80747 0
Level 10 North, King George V Building, Royal Prince Alfred Hospital (C39)
PO Box 179, Missenden Road NSW 2050
Country 80747 0
Australia
Phone 80747 0
+61 2 8627 6236
Fax 80747 0
Email 80747 0
Christina.Abdelshaheed@sydney.edu.au
Contact person for scientific queries
Name 80748 0
Dr Christina Abdel Shaheed
Address 80748 0
Level 10 North, King George V Building, Royal Prince Alfred Hospital (C39)
PO Box 179, Missenden Road NSW 2050
Country 80748 0
Australia
Phone 80748 0
+61 2 8627 6236
Fax 80748 0
Email 80748 0
Christina.Abdelshaheed@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No, participant ID will at no point be identifiable


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.