Clinical trial NCT04240483: Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department
Official title: Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department: a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
sterile water injection
emergency department
sterile water
acute low back pain
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2020-01-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Pain severity on 11-point Visual Analogue Scale (VAS)
timeFrame: pre-treatment
measure: Pain severity on 11-point Visual Analogue Scale (VAS)
timeFrame: 10 minutes post treatment
measure: Pain severity on 11-point Visual Analogue Scale (VAS)
timeFrame: 30 minutes post treatment
Secondary outcomes:
measure: Satisfaction score on 11-point Visual Analogue Scale (VAS)
timeFrame: 30 minutes post treatment
Other outcomes:
Locations:
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Military Medical Center
state: Nevada
Study officials:
affiliation: United States Air Force
name: Paul F Crawford, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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