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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240483
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Lindsey schmelzer, Mike O'Callaghan Military Hospital

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Intracutaneous sterile water injections (ISWI) group Other: Intracutaneous dry injections (IDI) group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department: a Pilot Study
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intracutaneous sterile water injections (ISWI) group 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.

Sham Comparator: Intracutaneous dry injections (IDI) group 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.




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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 Outcome Measures :
  1. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240483


Contacts
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Contact: Jill M Clark, MBA 7026533298 jill.m.clark15.ctr@mail.mil

Sponsors and Collaborators
Lindsey schmelzer
Investigators
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Study Director: Paul F Crawford, MD United States Air Force
Additional Information:
Publications:
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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Responsible Party: Lindsey schmelzer, Principal Investigator, Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT04240483    
Other Study ID Numbers: FWH20200050H
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan on sharing data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lindsey schmelzer, Mike O'Callaghan Military Hospital:
low back pain
sterile water injection
emergency department
sterile water
acute low back pain
Additional relevant MeSH terms:
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Infertility
Back Pain
Emergencies
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Disease Attributes
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female