Subcutaneous Sterile Water Injection for Relief of Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02813330
• Other study ID #: Women Health Hospital
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: June 18, 2016
• Last updated: June 21, 2016
• Start date: February 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 336
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Subcutaneous sterile water injection
sterile water injection in two points of low back pain
• saline injection
Saline injection in two points of low back pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	the investigator spend two hours with each client to measure the effect of pain relief	two hours for each client
Primary	Women's Saisfaction	measuring pain relief within different minutes	each 15 min until 120 min