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

NCT04240483 | Terminated

• 1 other identifier: FWH20200050H
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

low back pain; sterile water injection; emergency department; sterile water; acute low back pain

Outcome Measures

Primary Outcomes (3)

• Pain severity on 11-point Visual Analogue Scale (VAS)

  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.

  pre-treatment

• Pain severity on 11-point Visual Analogue Scale (VAS)

  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.

  10 minutes post treatment

• Pain severity on 11-point Visual Analogue Scale (VAS)

  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.

  30 minutes post treatment

Secondary Outcomes (1)

• Satisfaction score on 11-point Visual Analogue Scale (VAS)

  30 minutes post treatment

Study Arms (2)

Intracutaneous sterile water injections (ISWI) group

EXPERIMENTAL

Other: Intracutaneous sterile water injections (ISWI) group

Intracutaneous dry injections (IDI) group

SHAM COMPARATOR

Other: Intracutaneous dry injections (IDI) group

Interventions

Intracutaneous sterile water injections (ISWI) group OTHER

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.

Intracutaneous sterile water injections (ISWI) group

Intracutaneous dry injections (IDI) group OTHER

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.

Intracutaneous dry injections (IDI) group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lindsey schmelzer: lead

Study Sites (1)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (7)

• Byrn C, Olsson I, Falkheden L, Lindh M, Hosterey 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. doi: 10.1016/0140-6736(93)90204-t.

  PMID: 8094485 BACKGROUND

• 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):e5092. doi: 10.1590/1414-431X20155092. Epub 2016 Feb 2.

  PMID: 26840703 BACKGROUND

• Genc Koyucu R, Demirci N, Ender Yumru A, Salman S, Ayanoglu 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.

  PMID: 29072177 BACKGROUND

• 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. No abstract available.

  PMID: 25657569 BACKGROUND

• Martensson 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.

  PMID: 29241699 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

Related Links

• sterile water injections for pain relief

MeSH Terms

Conditions

Low Back Pain; Emergencies

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Paul F Crawford, MD

  United States Air Force

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: July 27, 2020
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)