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

Lindsey schmelzer

Status: Terminated

Conditions: Low Back Pain

Treatments: Other: Intracutaneous sterile water injections (ISWI) group; Other: Intracutaneous dry injections (IDI) group

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04240483

FWH20200050H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups

Intracutaneous sterile water injections (ISWI) group

Experimental group

Treatment:

Other: Intracutaneous sterile water injections (ISWI) group

Intracutaneous dry injections (IDI) group

Sham Comparator group

Treatment:

Other: Intracutaneous dry injections (IDI) group