NCT03990441

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

Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) Versus Placebo During the First Stage of Labor. Double-blind Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Transcutaneous Electric Nerve Stimulation
• Labor Pain

Interventions

Type	Name	Description
DEVICE	TENS	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.
DEVICE	TENS Placebo	Same application as Intervention, but using 0,1 mA as fixed intensity on both channels.

Timeline

• Start date: 2019-02-11
• Primary completion: 2020-02-01
• Completion: 2020-03-01
• First posted: 2019-06-19
• Last updated: 2019-06-19

Locations

1 site across 1 country: Spain