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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 : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Lindsey schmelzer, Mike O'Callaghan Military Hospital

Tracking Information
First Submitted Date  ICMJE January 21, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date May 6, 2020
Estimated Study Start Date  ICMJE May 2020
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
  • 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.
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department
Official Title  ICMJE Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department: a Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Intracutaneous sterile water injections (ISWI) group
    Intervention: Other: Intracutaneous sterile water injections (ISWI) group
  • Sham Comparator: Intracutaneous dry injections (IDI) group
    Intervention: Other: Intracutaneous dry injections (IDI) group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

**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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jill M Clark, MBA 7026533298 jill.m.clark15.ctr@mail.mil
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04240483
Other Study ID Numbers  ICMJE FWH20200050H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We do not plan on sharing data
Responsible Party Lindsey schmelzer, Mike O'Callaghan Military Hospital
Study Sponsor  ICMJE Lindsey schmelzer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Paul F Crawford, MD United States Air Force
PRS Account Mike O'Callaghan Military Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP