TENS for Postpartum Uterine Pain During Breastfeeding

Официальное название

Transcutaneous Electrical Nerve Stimulation for Treating Postpartum Uterine Pain During Breastfeeding in Multiparous Women: a Randomized Controlled Trial

Обзор

This clinical study is designed to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) is an effective, non-drug method to relieve postpartum uterine pain during breastfeeding in multiparous women (women who have given birth multiple times). Breastfeeding in the first 48 hours after delivery often triggers strong, painful uterine contractions due to the natural release of oxytocin. While standard care typically relies on pain-relief medications, this study investigates if TENS, a safe, low-cost device that sends gentle electrical impulses through small skin patches, can significantly reduce this pain and decrease the need for systemic medications. Participants will be randomly assigned to either receive standard postpartum pain medications or use a TENS device during two consecutive breastfeeding sessions. Researchers will measure and compare the peak pain levels between both groups using a standard 0 to 10 pain scale. The aim is examining whether TENS will significantly reduce postpartum uterine pain during breastfeeding and decrease medication use compared with standard care.

Подробное описание

This randomized, controlled, parallel-group clinical trial will evaluate the efficacy and safety of Transcutaneous Electrical Nerve Stimulation (TENS) as a non-pharmacological intervention for reducing oxytocin-induced postpartum uterine contractions during breastfeeding. The study cohort consists of 124 eligible multiparous women (2 or more previous births) admitted to the Department of Obstetrics and Gynecology at Holy Family Hospital in Nazareth, Israel, within 48 hours following a term, singleton, vaginal delivery. Following the acquisition of written informed consent, participants will be randomized at a 1:1 ratio into either the TENS study group or the standard care control group. The experimental protocol will be integrated into two consecutive breastfeeding sessions. Body positioning will be strictly standardized across both cohorts. TENS Study Group (Intervention): Prior to the second consecutive breastfeeding session, four conductive gel electrodes will be affixed to the participant. Two electrodes will be positioned bilaterally over the lower abdomen, directly overlying the uterus. The remaining two electrodes will be placed in parallel in the S2-S4 dermatomal region to target the spinal nerve pathways receiving nociceptive afferent input from the uterus and cervix. Active stimulation will commence a few minutes prior to breastfeeding and continue for the entire duration of the feed. The TENS device will deliver a 100-Hz current and 75 msec pulse for 40 min, using 20-60 milliamps of intensity.

To establish a baseline pain score, the first evaluated breastfeeding session for this group will be conducted without TENS application, followed by active TENS during the second session. Control Group Protocol: Participants assigned to the control group will receive standard postpartum care and will undergo the identical data collection schedule across two consecutive breastfeeding sessions, but without any TENS electrode placement or electrical stimulation.

For both study arms, pharmacological analgesia will remain accessible as needed per existing institutional department protocols, and all instances of medication administration (including specific agent, timing, and dosage) will be precisely documented. Uterine pain scores will be captured across both groups at three identical time points during each of the two consecutive breastfeeding sessions: Maternal discomfort associated directly with the physical application or sensation of the TENS unit will be separately quantified.

Вмешательства

• Устройство Transcutaneous Electrical Nerve Stimulation (TENS)
  Bilateral application of four skin electrodes using conductive gel. Two electrodes will be placed on the lower abdomen over the uterus, and two will be placed in parallel in the S2-S4 sacral region. The digital sensory-motor TENS device will be programmed to generate a 100-Hz current and 75 msec pulse for 40 min, using 20-60 mA of intensity. Stimulation begins a few minutes before breastfeeding and continues throughout the 40-minute session.

Первичные конечные точки

• Peak VAS pain score during breastfeeding in the second session [Срок оценки: During the second breastfeeding session, within the first 48 hours postpartum]

Вторичные конечные точки (6)

• Consumption of Pharmacological Analgesics [Срок оценки: First 48 hours postpartum]
• Peak VAS pain score during breastfeeding in the second compared with the first sessions. [Срок оценки: During two consecutive breastfeeding sessions within the first 48 hours postpartum]
• Duration of breastfeeding sessions. [Срок оценки: In the two consecutive breastfeeding sessions within the first 48 hours postpartum]
• Adverse effects related to TENS use [Срок оценки: During the second session, within the first 48 hours postpartum]
• Maternal discomfort [Срок оценки: First 48 hours postpartum]
• Formula use [Срок оценки: First 48 hours postpartum]

Критерии участия

Критерии включения

• Maternal Age above 18
• Term delivery (37 weeks or more)
• Vaginal delivery within the past 48 hours.
• Multiparous women (2 or more previous births)
• Delivery of a singleton
• Have the well to breastfeed

Критерии исключения

• Contraindication to TENS (pacemaker, epilepsy, active infection, uncontrolled hyper / hypotension.)
• Chronic analgesia use
• Severe complications requiring intervention (severe PPH) or intensive care
• Skin lesions, infections, or scars at proposed electrode sites
• Neonatal intensive care unit admission

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Израиль · 1 центр

• Holy Family Hospital — Nazareth

Публикации

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• Alswied A, Chen LN, West-Mitchell KA. Longitudinal assessment of erythrogram parameters in response to granulocytapheresis frequency: A sex-based analysis. Vox Sang. 2025 Mar;120(3):268-276. doi: 10.1111/vox.13788. Epub 2025 Jan 1. PMID 39743343
• Vera Pingitore E, Hebert EM, Sesma F, Nader-Macias ME. Influence of vitamins and osmolites on growth and bacteriocin production by Lactobacillus salivarius CRL 1328 in a chemically defined medium. Can J Microbiol. 2009 Mar;55(3):304-10. doi: 10.1139/w08-092. PMID 19370073
• Kahila H, Saisto T, Kivitie-Kallio S, Haukkamaa M, Halmesmaki E. A prospective study on buprenorphine use during pregnancy: effects on maternal and neonatal outcome. Acta Obstet Gynecol Scand. 2007;86(2):185-90. doi: 10.1080/00016340601110770. PMID 17364281
• Radhakrishnan R, Moore SA, Sluka KA. Unilateral carrageenan injection into muscle or joint induces chronic bilateral hyperalgesia in rats. Pain. 2003 Aug;104(3):567-577. doi: 10.1016/S0304-3959(03)00114-3. PMID 12927629
• Silbert BI, Lam SJ, Henderson RD, Lake FR. Students as teachers. Med J Aust. 2013 Dec 16;199(11):757. doi: 10.5694/mja13.11353. No abstract available. PMID 24329649

Идентификаторы

NCT: NCT07703917 · HFH-321/2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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