None listed
Conditions
Brief summary
Based on current medical literature, there are some suggestions that a single dose of steroid treatment may help improve back pain due to low back pain with radiculopathy. However, the research this has been based on has not been performed in the Emergency Department (ED), or do not necessarily measure important factors such as return to normal functioning, visual analogue pain scores or improvement in straight leg raise. The aim of project is to measure and compare the effect of a single dose of intravenous steroid treatment (8 mg of Dexamethasone) versus a placebo (normal saline) on visual analogue pain scores. We are also trying to measure the time to return to normal functional level, improvement in straight leg raising and improvement in Oswestry Disability Index symptom scores. The overall aim is to make a recommendation regarding management of patients with acute back pain and radiculopathy.
Interventions
In the treatment group, each participant will be given a single dose of 8 mg Dexamethasone diluted with 0.9% NaCl solution to 10ml total via intravenous route. They will be admitted for routine care in the observation ward of the emergency department until they meet discharge criteria. Routine care consists of a standardized regimen of regular analgesia (paracetamol+codeine, iburprofen, PRN Oxycodone) and physiotherapy referral/education. Discharge criteria include: mobilizing safely without ass
In the treatment group, each participant will be given a single dose of 8 mg Dexamethasone diluted with 0.9% NaCl solution to 10ml total via intravenous route. They will be admitted for routine care in the observation ward of the emergency department until they meet discharge criteria. Routine care consists of a standardized regimen of regular analgesia (paracetamol+codeine, iburprofen, PRN Oxycodone) and physiotherapy referral/education. Discharge criteria include: mobilizing safely without assistance, tolerable pain levels, self-caring
Sponsors
Dr Gerben Keijzers
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
(1) Low back pain with radiculopathy – Defined as a history of a dermatomal distribution of pain, an increase in pain on coughing, sneezing, or straining, paroxysmal pain, and predominant leg pain (2) Straight leg test positive - The straight leg raise test is deemed to be positive when there is reproduction of pain in the sciatic nerve distribution of the affected leg between 0 to 70 degrees, with the patient in the supine position with no pillow, a flat bed in 180 degrees horizontal, with the patient’s head and pelvis in the 180 degrees horizontal plane. (3) Unable to mobilize safely without assistance
Exclusion criteria
(1) Declines intravenous cannulation (2) Below 18 or over 55 (3) People with intellectual or mental impairment (4) Allergy to dexamethasone or NS (5) Red flags: fever, history of malignancy, recent significant trauma, ectopic pregnancy (6) Medical conditions were steroids are contraindicated or are being given (current asthma using oral steroids, body builders using anabolic steroids) (7) History of lower back surgery
Outcome results
None listed