Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department
NCT ID: NCT04240483
Last Updated: 2022-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2020-07-27
2021-02-08
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intracutaneous sterile water injections (ISWI) group
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.
Intracutaneous dry injections (IDI) group
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
No
Sponsors
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Lindsey schmelzer
FED
Responsible Party
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Lindsey schmelzer
Principal Investigator
Principal Investigators
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Paul F Crawford, MD
Role: STUDY_DIRECTOR
United States Air Force
Locations
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Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, United States
Countries
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References
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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.
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.
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.
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.
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.
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
Provided Documents
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Document Type: Informed Consent Form
Related Links
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sterile water injections for pain relief
Other Identifiers
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FWH20200050H
Identifier Type: -
Identifier Source: org_study_id
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