The purpose of this study is to evaluate the efficacy of intracutaneous sterile water injections (ISWI) for treatment of acute low back pain in patients presenting to the emergency department. The primary aim is to determine if ISWI provides pain relief for acute low back pain in the ED. The secondary aim is to evaluate whether ISWI provides improved patient satisfaction in the ED setting. The hypothesis is that ISWI will improve pain amongst patients presenting with acute low back pain to the ED.
The purpose of this study is to evaluate the efficacy of intracutaneous sterile water injections (ISWI) for treatment of acute low back pain in patients presenting to the emergency department. The primary aim is to determine if ISWI provides pain relief for acute low back pain in the ED. The secondary aim is to evaluate whether ISWI provides improved patient satisfaction in the ED setting. The hypothesis is that ISWI will improve pain amongst patients presenting with acute low back pain to the ED. This pilot study will use a randomized controlled trial design to compare the effects of ISWI to intracutaneous dry injections in patients presenting to the ED with acute low back pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
6
ISWI consists of 4 intracutaneous injections of 0.5 ml sterile water in the lumbosacral region while patient is in a seated position. One injection given at the posterior superior iliac spine (Point 1) on both sides and second injection at 1 cm medial, and 1-2 cm inferior to the first point on both the sides (Point 2) using an insulin needle. These points overlie the area called Michaelis' rhomboid.
Intracutaneous dry injections will be performed in the same manner described above, however, no sterile water or alternative solutions will be injected into the sites.
Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, United States
Pain severity on 11-point Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case the scale is accompanied by the Wong-Baker faces pain rating scale. Min pain score is 0, max pain score is 10. Lower scores mean a better outcome and higher scores mean greater pain severity.
Time frame: pre-treatment
Pain severity on 11-point Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case the scale is accompanied by the Wong-Baker faces pain rating scale. Min pain score is 0, max pain score is 10. Lower scores mean a better outcome and higher scores mean greater pain severity.
Time frame: 10 minutes post treatment
Pain severity on 11-point Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case the scale is accompanied by the Wong-Baker faces pain rating scale. Min pain score is 0, max pain score is 10. Lower scores mean a better outcome and higher scores mean greater pain severity.
Time frame: 30 minutes post treatment
Satisfaction score on 11-point Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. In this case the VAS is a horizontal line ranging from left to right for unsatisfied to highly satisfied. Min pain score is 0, max pain score is 10.
Time frame: 30 minutes post treatment
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