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Subcutaneous Sterile Water Injection for Relief of Low Back Pain

Subcutaneous Sterile Water Injection for Relief of Low Back Pain During Normal Labor: Randomized Controlled Study

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02813330
Enrollment
336
Registered
2016-06-27
Start date
2015-02-28
Completion date
2016-06-30
Last updated
2016-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Women, severe, low back ache, labor

Brief summary

To compare the effect of subcutenous sterile water injection technique with the subcutaneous saline injection technique in the degree and duration of low back pain-relieving during childbirth

Detailed description

Study sample: The convenience sample will be recruited randomly on the basic of odd number will have saline injection and even number will be given a placebo (Sterile water injection) Setting: Labor ward in Women's health center at Assiut university hospital Study design: Experimental Randomized control study Sample size: The sample size was calculated using the formula N= (Zα+Zβ)2 x 2p(1-p)÷d2 ,taking the level of significance as 5%, Zα=1.96 and power of the test as 80%, Zβ=0.84. p=0.113. A sample size of 165 in each group was calculated. Total of 330 women will be studied (165 in each arm) Inclusion criteria * In labour (spontaneous or induced * During first stageof labour * Primary and multiparous women * A term singleton pregnancy (between 37 + 0 and 41 weeks) * Have a fetus in a cephalic presentation * Experience back pain assessed by visual analogue scale VAS and Face pain analogue ( Warden V, Hurley AC, Volicer L.2003) * Provide informed consent. Exclusion criteria * Multiple pregnancy * Malpresentation (breech, transverse, shoulder) * Previous CS * Infection or inflammation at the injection sites or complications that could cause bleeding at injection site eg. Thrombocytopenia. Study Tools: 1. Personal data questionnaire 2. Visual Analogue Scale and Face analogue scale 3. Satisfaction scale

Interventions

OTHERSubcutaneous sterile water injection

sterile water injection in two points of low back pain

OTHERsaline injection

Saline injection in two points of low back pain

Sponsors

Woman's Health University Hospital, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* In labour (spontaneous or induced record * During first stage of labour * Primary and multiparous women * A term singleton pregnancy (between 37 + 0 and 41 weeks) * Have a fetus in a cephalic presentation * Experience back pain assessed by visual analogue scale VAS and Face pain analogue * Provide informed consent.

Exclusion criteria

* Women with chronic disease * Medical condition associated with pregnancy ( Pre-eclampsia- Eclampsia- Diabetic pregnancy.... etc) * Complicated labor process ( obstructed, preterm labor, twins)

Design outcomes

Primary

MeasureTime frameDescription
Pain relieftwo hours for each clientthe investigator spend two hours with each client to measure the effect of pain relief
Women's Saisfactioneach 15 min until 120 minmeasuring pain relief within different minutes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026