NCT02813330

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Woman's Health University Hospital, Egypt · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	Subcutaneous sterile water injection	sterile water injection in two points of low back pain
OTHER	saline injection	Saline injection in two points of low back pain

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-06-27
• Last updated: 2016-06-27