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

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intracutaneous sterile water injections (ISWI) group

Intracutaneous dry injections (IDI) group

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, sterile water injection, emergency department, sterile water, acute low back pain

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

**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

Sites / Locations

Mike O'Callaghan Military Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intracutaneous sterile water injections (ISWI) group

Intracutaneous dry injections (IDI) group

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Satisfaction score 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 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.

Full Information

NCT ID

NCT04240483

First Posted

January 21, 2020

Last Updated

January 13, 2022

Sponsor

Lindsey schmelzer

1. Study Identification

Unique Protocol Identification Number

NCT04240483

Brief Title

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

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Terminated

Why Stopped

Study closed at Principal Investigator's request (study initiated, but not complete). Only 6 subjects had been recruited. The same study was just published.

Study Start Date

July 27, 2020 (Actual)

Primary Completion Date

February 8, 2021 (Actual)

Study Completion Date

February 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lindsey schmelzer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intracutaneous sterile water injections (ISWI) group

Arm Type

Experimental

Arm Title

Intracutaneous dry injections (IDI) group

Arm Type

Sham Comparator

Intervention Type

Other

Intervention Name(s)

Intracutaneous sterile water injections (ISWI) group

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Intracutaneous dry injections (IDI) group

Intervention Description

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 Measure Information:

Title

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

Description

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.

Time Frame

pre-treatment

Title

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

Description

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.

Time Frame

10 minutes post treatment

Title

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

Description

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.

Time Frame

30 minutes post treatment

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

30 minutes post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul F Crawford, MD

Organizational Affiliation

United States Air Force

Official's Role

Study Director

Facility Information:

Facility Name

Mike O'Callaghan Military Medical Center

City

Nellis Air Force Base

State/Province

Nevada

ZIP/Postal Code

89191

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

IPD Sharing Plan Description

We do not plan on sharing data

Citations:

PubMed Identifier

8094485

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.

Results Reference

background

PubMed Identifier

26840703

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.

Results Reference

background

PubMed Identifier

29072177

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.

Results Reference

background

PubMed Identifier

25657569

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.

Results Reference

background

PubMed Identifier

29241699

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.

Results Reference

background

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

Results Reference

background

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

Results Reference

background

Links:

URL

https://sciencebasedmedicine.org/sterile-water-injections-for-pain-relief/

Description

sterile water injections for pain relief

Low Back Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial