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

Not Applicable

Terminated

• Conditions: Low Back Pain
• Interventions: Other: Intracutaneous sterile water injections (ISWI) group; Other: Intracutaneous dry injections (IDI) group

• Registration Number: NCT04240483
• Lead Sponsor: Lindsey schmelzer

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 Timeline

• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Study Start: 2020-07-27
• Primary Completion: 2021-02-08
• Study Completion: 2021-02-08
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracutaneous sterile water injections (ISWI) group	Intracutaneous sterile water injections (ISWI) group	-
Intracutaneous dry injections (IDI) group	Intracutaneous dry injections (IDI) group	-

Primary Outcome Measures

Name	Time	Method
Pain severity on 11-point Visual Analogue Scale (VAS)	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 Outcome Measures

Name	Time	Method
Satisfaction score on 11-point Visual Analogue Scale (VAS)	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 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.

Trial Locations

Locations (1)

Mike O'Callaghan Military Medical Center; 🇺🇸 Nellis Air Force Base, Nevada, United States