None listed
Conditions
Brief summary
This study will recruit participants who attend Armadale Hospital (public) Emergency Department (ED) with acute low back pain. They will be randomized into groups, and the intervention group fitted with an abdominal brace. The hypothesis is that in people with mechanical low back pain, wearing a brace will reduce their pain (and increase activity and quality of life [QoL]). The participants will be asked to wear the brace for up to 30 days when in pain during the day and if they feel that the brace is helpful. Low back pain, function, QoL and health care usage will be tracked for 3 months from the date of attendance at ED.
Interventions
Patients in the Emergency Department will be screened (red flags) by their receiving doctor and have their medical interventions completed prior to being referred to the Senior Physiotherapist. The PT will complete the consent process and patients will then be allocated randomly to the intervention (brace + routine care) or control (routine care) group. For those allocated to the intervention group, an Aspen Horizon 627 elasticised abdominal brace, adjusted to accommodate each individual's girth
Patients in the Emergency Department will be screened (red flags) by their receiving doctor and have their medical interventions completed prior to being referred to the Senior Physiotherapist. The PT will complete the consent process and patients will then be allocated randomly to the intervention (brace + routine care) or control (routine care) group. For those allocated to the intervention group, an Aspen Horizon 627 elasticised abdominal brace, adjusted to accommodate each individual's girth will be fitted in the Emergency Department by qualified physiotherapist. The participant will be provided with all routine care around the fitting of the brace, namely reassurance, education and exercises as per the Australian National Clinical Care Standard for Low Back Pain (Sept 2022). Recruitment into the study is estimated to take 15 minutes, fitting the brace a further 15 minutes and all other routine care 30-45 minutes depending on the patient acuity, mobility and medical screen. The participant will be asked to wear the brace during the day for up to 30 days. They will complete their prescribed exercises and go about their functional and work tasks as able with the brace in situ. The adherence to the brace protocol will be surveyed 3 x per week and self-reported wear time will be recorded (survey received via sms link).
Sponsors
University of Alberta
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) aged between 18 and older; 2) ambulatory; 3) able to read and understand English; 4) living in Perth, Western Australia; and 5) presenting to the Emergency Department of the Armadale Hospital.
Exclusion criteria
1) waist circumference <61 or >175cm; 2) back pain due to systemic or specific disease such as known cancer, spinal infection, fracture, or ankylosing spondylitis; 3) pregnancy; 4) significant compression of the spinal cord/nerves; 5) previous back surgery; and 6) on-going workers’ compensation or litigation cases.
Outcome results
None listed