Abdominal bracing for adult acute low back pain in the Emergency Department: A randomised controlled trial exploring impact on pain, function and healthcare use.

INTERVENTION: 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 Xper week and self‐reported wear time will be recorded (survey received via sms link). CONDITION: Acute Low Back Pain; ; Acute Low Back Pain Musculoskeletal ‐ Other muscular and skeletal disorders PRIMARY OUTCOME: Pain[VAS 0‐10 scale The primary outcome is pain report. It will be measured at baseline (Day 0) (at recruitment, prior to treatment); days 2, 4, 7 (week 1); days 9, 11, 14 (week 2); days 16, 18, 21 (week 3); days 23, 25, 28 (primary endpoint); day 60 (month 2 ‐ 8 weeks after commencement of treatment); and, day 90 (month 3 ‐ 12 weeks after commencement of treatment). Month 2 and 3 will be collected 1 and 2 months respectively after cessation of treatment. ] SECONDARY OUTCOME: Adverse outcomes associated with wearing brace: ; Any skin irritation or possible contact allergy which is worsening and, or not settling with standard advice (wear breaks, moisturiser application). [Patient report via sms survey. As per protocol, adverse outcomes may be reported at the 7 ‐ 10 day telephone consultation. ; Within 30 days (brace wear protocol) via sms survey responses at 2, 4, 7, 9, 11, 14, 16, 18, 21, 23, 25, 28 days. ; ] Adverse outcomes associated with wearing brace: ; Lower limb swelling which is worsening and, or not settling with standard advice (wear breaks). [Patient report via sms survey. As per protocol, adverse outcomes may be reported at the 7 ‐ 10 day telephone consultation. ; Within 30 days (brace wear protocol) via sms survey responses at 2, 4, 7, 9, 11, 14, 16, 18, 21, 23, 25, 28 days.] Analgesic use analysed as a composite measure (total number of tablets, all medication types). Type of medication and frequency will be recorded for descriptive analysis.[Patient report via SMS survey (coupled to pain reporting). Analgesic use will be measured at baseline (Day 0) (referring to days prior to recruitment); days 2, 4, 7 (week 1); days 9, 11, 14 (week 2); days 16, 18, 21 (week 3); days 23, 25, 28; day 60 (month 2 ‐ 8 weeks after commencement of treatment); and, day 90 (month 3 ‐ 12 weeks after commencement of treatment). ] Function[Oswestry Disability Inde XOswestry DI will be captured: At baseline (taken prior to commencement of treatment) and weeks 1, 2, 3, 4, 8 (2 months); 12 (3 months) after commencement of treatment. Month 2 and 3 will be collected 1 and 2 months respectively after cessation of treatment.] 1 and 2 months respectively after cessation of treatment.] Health care usage[Count of health care contacts will be captured for all recruited participants (via self‐report to SMS survey). The schedule will be anchored on recruitment (baseline) date ie day of attendance at ED. At baseline (health care contacts reported prior to commencement of treatment in ED for this instance of LBP) and then repeated question at weeks 1, 2, 3, 4, 8 (2 months after ED attendance); 12 (3 months after ED attendance) after commencement of treatment. ] Quality of Life[EQ5D‐5L EQ‐5D will be captured: At baseline (taken prior to commencement of treatment) and weeks 1, 2, 3, 4, 8 (2 months); 12 (3 months) after commencement of treatment. Month 2 and 3 will be collected 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.