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

NCT04240483 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-01-28

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

OTHER

Intracutaneous sterile water injections (ISWI) group

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.

OTHER

Intracutaneous dry injections (IDI) group

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.

Sponsors & Collaborators

  • Lindsey schmelzer

    lead FED

Principal Investigators

  • Paul F Crawford, MD · United States Air Force

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2021-02-08
Completion
2021-02-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04240483 on ClinicalTrials.gov