Low Back PainNCT04240483
Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department
A study testing Intracutaneous sterile water injections (ISWI) group and Intracutaneous dry injections (IDI) group in people with Low Back Pain, run by Lindsey schmelzer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Intracutaneous sterile water injections (ISWI) group and Intracutaneous dry injections (IDI) group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2020to 8 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Traumatic low back pain
- New weakness or neurologic deficit
- New loss bowel/bladder control
- Back pain above T12
- Active cancer
- Currently taking anticoagulant medications
Show all 9Show fewer
- Signs of infection or trauma over the injection site
- Non-English speaking
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, 89191
About this study
Official title: Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department: a Pilot Study
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Intracutaneous sterile water injections (ISWI) group, Intracutaneous dry injections (IDI) group
- Keywords
- low back pain, sterile water injection, emergency department, sterile water, acute low back pain
- Medical subject headings
- Low Back Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracutaneous sterile water injections (ISWI) groupOther
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) groupOther
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 group | Role | What they receive |
|---|---|---|
| Intracutaneous sterile water injections (ISWI) group | Experimental | Not described Receives: Other: Intracutaneous sterile water injections (ISWI) group |
| Intracutaneous dry injections (IDI) group | Sham comparator | Not described Receives: Other: Intracutaneous dry injections (IDI) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-treatment
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.
Measured: 10 minutes post treatment
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.
Measured: 30 minutes post treatment
Secondary outcomes (1)
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.
Measured: 30 minutes post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start27 Jul 2020
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindsey schmelzer
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Lindsey schmelzer, Mike O'Callaghan Military Hospital
- Investigators
- Paul F Crawford, MD, Study director, United States Air Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240483
- Sponsor's protocol ID
- FWH20200050H
- Status last verified
- Jan 2022
- First submitted
- 21 Jan 2020
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan on sharing data
Publications
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.
PubMed 8094485Cui 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.
PubMed 26840703Genc 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.
PubMed 29072177Hosseininejad 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.
PubMed 25657569Martensson 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.
PubMed 29241699S, 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracutaneous Sterile Water Injections for Acute Low Back Pain in the Emergency Department: a Pilot Study
- ClinicalTrials.gov ID
- NCT04240483
- Acronym / sponsor ID
- FWH20200050H
- Conditions
- Low Back Pain
- Keywords
- low back pain, sterile water injection, emergency department, sterile water, acute low back pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Lindsey schmelzerUS federal agency
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracutaneous sterile water injections (ISWI) group | Experimental | Other: Intracutaneous sterile water injections (ISWI) group |
| Intracutaneous dry injections (IDI) group | Sham comparator | Other: Intracutaneous dry injections (IDI) group |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- Traumatic low back pain
- New weakness or neurologic deficit
- New loss bowel/bladder control
- Back pain above T12
- Active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracutaneous sterile water injections (ISWI) groupISWI 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 sterile water injections (ISWI) group |
| Intracutaneous dry injections (IDI) groupIntracutaneous dry injections will be performed in the same manner described above, however, no sterile water or alternative solutions will be injected into the sites. | Other | Intracutaneous dry injections (IDI) group |
Primary outcome
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.
1 secondary outcome
Satisfaction score on 11-point Visual Analogue Scale (VAS)
Time frame: 30 minutes post treatment
Results and safety
The study was stopped early (reason given: Study closed at Principal Investigator's request (study initiated, but not complete). Only 6 subjects had been recruited. The same study was just published.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Background: PubMed 8094485Byrn 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.
- Background: PubMed 26840703Cui 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.
- Background: PubMed 29072177Genc 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.
- Background: PubMed 25657569Hosseininejad 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.
- Background: PubMed 29241699Martensson 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.
- BackgroundS, 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
- BackgroundSkinner, 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
- sterile water injections for pain reliefLink provided by the sponsor.
- Individual participant dataSharing planned: No. We do not plan on sharing data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul F Crawford, MD study director
United States Air Force
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracutaneous sterile water injections (ISWI) group and Intracutaneous dry injections (IDI) group in people with Low Back Pain, run by Lindsey schmelzer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study closed at Principal Investigator's request (study initiated, but not complete). Only 6 subjects had been recruited. The same study was just published.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity on 11-point Visual Analogue Scale (VAS) (time frame: pre-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04240483, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.