A RESEARCH STUDY COMPARING REDUCTION OF LOW BACK PAIN DURING CHILDBIRTH IN WOMEN RECEIVING STERILE WATER INJECTIONS INTO THE SKIN VERSUS ONLY PRICKING

ANALGESIC EFFICACY OF INTRADERMAL STERILE WATER INJECTION FOR LOW BACK PAIN DURING LABOUR A RANDOMISED SINGLE BLINDED PLACEBO CONTROLLED TRIAL - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/109240

Enrollment

Registered

2026-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: sterile water: 0.1 ml of sterile water injection intradermally at 4 points over sacral area corresponding to Michaelis rhomboid area Intervention2: sterile water: 0.1 ml of sterile wate

Eligibility

Inclusion criteria

Inclusion criteria: Singleton pregnancy 37 to 42 weeks of gestation Cephalic presentation with Vertex presenting part Active labour which includes more than 4cm cervical dilatation Planned for vaginal delivery Moderate to severe low back pain Age between 18 and 35 years Willingness to participate and provide informed consent

Exclusion criteria

Exclusion criteria: High risk pregnancy eg preeclampsia antepartum haemorrhage Use of systemic analgesia within the past 4 hours Skin lesions or infection at injection site Women who request or have received epidural analgesia

Design outcomes

Primary

Measure	Time frame
To evaluate the effectiveness of intradermal sterile water injections in reducing low back pain during the first stage of labour when compared to the placebo which is dry injection without fluidTimepoint: VAS scores will be recorded at the following intervals Baseline preinjection At 10 minutes postinjection At 30 minutes postinjection At 60 minutes postinjection At 90 minutes postinjection At 120 minutes postinjection Patient will continue to be in the study irrespective of the final mode of delivery provided that delivery is at least 90 minutes after the injection Maternal satisfaction with pain relief will also be evaluated with a questionnaire within 24 hours of delivery	—

Measure

Time frame

To evaluate the effectiveness of intradermal sterile water injections in reducing low back pain during the first stage of labour when compared to the placebo which is dry injection without fluidTimepoint: VAS scores will be recorded at the following intervals Baseline preinjection At 10 minutes postinjection At 30 minutes postinjection At 60 minutes postinjection At 90 minutes postinjection At 120 minutes postinjection Patient will continue to be in the study irrespective of the final mode of delivery provided that delivery is at least 90 minutes after the injection Maternal satisfaction with pain relief will also be evaluated with a questionnaire within 24 hours of delivery

—

Secondary

Measure	Time frame
To assess maternal satisfaction with the intervention To assess the duration of pain relief with the intervention Timepoint: within 24 hours of delivery	—

Countries

India

Contacts

Public ContactSamskruthi G S

S NIJALINGAPPA MEDICAL COLLEGE

katagerigm@gmail.com9448776044

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026