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

Overview

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 Title of Study: “Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department: a Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 8, 2021

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.

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.

Arms, Groups and Cohorts

  • Experimental: Intracutaneous sterile water injections (ISWI) group
  • Sham Comparator: Intracutaneous dry injections (IDI) group

Clinical Trial Outcome Measures

Primary Measures

  • Pain severity on 11-point Visual Analogue Scale (VAS)
    • Time Frame: pre-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.
  • Pain severity on 11-point Visual Analogue Scale (VAS)
    • Time Frame: 10 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.
  • 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 Measures

  • Satisfaction score 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 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.

Participating in This Clinical Trial

**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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Lindsey schmelzer
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Lindsey schmelzer, Principal Investigator – Mike O’Callaghan Military Hospital
  • Overall Official(s)
    • Paul F Crawford, MD, Study Director, United States Air Force

References

Byrn C, Olsson I, Falkheden L, Lindh M, Hösterey U, Fogelberg M, Linder LE, Bunketorp O. Subcutaneous sterile water injections for chronic neck and shoulder pain following whiplash injuries. Lancet. 1993 Feb 20;341(8843):449-52.

Cui JZ, Geng ZS, Zhang YH, Feng JY, Zhu P, Zhang XB. Effects of intracutaneous injections of sterile water in patients with acute low back pain: a randomized, controlled, clinical trial. Braz J Med Biol Res. 2016 Mar;49(3). pii: S0100-879X2016000300704. doi: 10.1590/1414-431X20155092. Epub 2016 Feb 2.

Genç Koyucu R, Demirci N, Ender Yumru A, Salman S, Ayanoğlu YT, Tosun Y, Tayfur C. Effects of Intradermal Sterile Water Injections in Women with Low Back Pain in Labor: A Randomized, Controlled, Clinical Trial. Balkan Med J. 2018 Mar 15;35(2):148-154. doi: 10.4274/balkanmedj.2016.0879. Epub 2017 Oct 26.

Hosseininejad SM, Emami Zeydi A. Can intracutaneous sterile water injection be used as a possible treatment for acute renal colic pain in the emergency department? A short literature review. Urol Ann. 2015 Jan-Mar;7(1):130-2. doi: 10.4103/0974-7796.148669.

Mårtensson LB, Hutton EK, Lee N, Kildea S, Gao Y, Bergh I. Sterile water injections for childbirth pain: An evidenced based guide to practice. Women Birth. 2018 Oct;31(5):380-385. doi: 10.1016/j.wombi.2017.12.001. Epub 2017 Dec 11.

S, Valarmathy, and Josephine Hema j. "Intracutaneous sterile water injection over sacrum for the relief of low back pain in labour." Journal of Evolution of Medical and Dental Sciences, vol. 7, no. 28, 2018, pp. 3151-54, doi:10.14260/jemds/2018/709

Skinner, Virginia, et al. "Sterile Water Injections for Relief of Back Pain in Labour – a Qualitative Study." Women and Birth, vol. 31, Oct. 2018, p. S50. ScienceDirect, doi:10.1016/j.wombi.2018.08.149

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