Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department: a Pilot Study

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Intracutaneous sterile water injections (ISWI) group
* Other: Intracutaneous dry injections (IDI) group


Participation Criteria
=================
Eligibility Criteria
-----------------
**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study** Inclusion Criteria: Active Duty and DoD Beneficiaries aged 18 to 64 years. Presenting to the ED with a chief complaint of acute low back pain of less than 2 weeks in duration. Pain severity on presentation of greater than or equal to 5/10 on Visual Analogue Scale. Exclusion Criteria: Traumatic low back pain New weakness or neurologic deficit New loss bowel/bladder control Back pain above T12 Active cancer Currently taking anticoagulant medications Signs of infection or trauma over the injection site Non-English speaking Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracutaneous sterile water injections (ISWI) group<br> | Other: Intracutaneous sterile water injections (ISWI) group<br>* 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.<br>|
| Sham Comparator: Intracutaneous dry injections (IDI) group<br> | Other: Intracutaneous dry injections (IDI) group<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 30 minutes post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 minutes post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, sterile water injection, emergency department, sterile water, acute low back pain