Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) Versus Placebo During the First Stage of Labor

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Status: Unknown

Conditions: Labor Pain; Transcutaneous Electric Nerve Stimulation

Treatments: Device: TENS Placebo; Device: TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT03990441

SOS1

Details and patient eligibility

About

This study seeks to verify the analgesic efficacy of TENS during the first stage of labor applying TENS parameters that, according to with the evidence, can be effective for this application and discarding the placebo effect according to the methodological recommendations.

Full description

TENS is a non-pharmacological alternative for pain control during labor. Although it's a method that has been used for decades, there is not enough evidence on its efficacy, so it's considered ineffective in the Spanish and British guidelines of clinical practice. The present study seeks to verify the analgesic efficacy of TENS by applying the electrodes in the spinal nerve roots associated with labor pain and using conventional TENS with parameters that, according to the evidence, may be effective for this application.

Enrollment: 46 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women attending routinary fetal monitoring before labor

Exclusion criteria

• Multiparous
• Scheduled cesarean
• Implantable Cardioverter Defibrillator (ICD) or pacemaker
• Epilepsy
• Fetal malformation
• Language barrier

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

46 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

TENS application using the TensMed S82 (Enraf Nonius). Current parameters: balanced symmetric biphasic square waveform, continuous stimulation, frequency 80 Hz, pulse duration modulated between 250 and 290 μs, modulation time 5 seconds. Self-adhesive electrodes of 50 x 90 mm applied paravertebrally to 2 cm. of the spinous apophysis. Use of two channels with independent intensity (mA): electrodes of the first channel applied at level T10-L1 and second channel ones at level S2-S4. Maximum intensity without reaching pain, increasing the intensity throughout the application to maintain this level. Start of the intervention when the woman expresses pain. End of the intervention when neuraxial anesthesia is applied (if the woman demands it) or after delivery.

Treatment:

Device: TENS

Placebo

Placebo Comparator group

Description:

Same application as Intervention, but using 0,1 mA as fixed intensity on both channels.

Treatment:

Device: TENS Placebo