None listed
Conditions
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.
Interventions
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
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.
Sponsors
University of Sydney
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed