Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department: a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Pain severity on 11-point Visual Analogue Scale (VAS)
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Outcomes
Primary Outcomes
Pain severity on 11-point Visual Analogue Scale (VAS)
Time Frame: 30 minutes post treatment
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.
Secondary Outcomes
- Satisfaction score on 11-point Visual Analogue Scale (VAS)(30 minutes post treatment)
Investigators
Lindsey schmelzer
Principal Investigator
Mike O'Callaghan Military Hospital