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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03990441
• Other study ID #: SOS1
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2019
• Est. completion date: March 2020

Study information

• Verified date: June 2019
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: Manuel José Sos Gallén, PT, PGCert
• Phone: +34610736702
• Email: sos[@]pipeline.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: March 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain
• Transcutaneous Electric Nerve Stimulation

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Castellón	Castellón De La Plana	Castellón

Sponsors (2)

Lead Sponsor	Collaborator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana	Hospital General Universitario de Castellón

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity measure	Self reported pain intensity. Score 0-10 (0 = no pain, 10 = pain as bad as can be), using a 0-10 pain scale combined with colored faces pain scale, for measuring the change of pain.	Start of intervention, each 30 minutes during intervention, end of intervention (when neuraxial anesthesia is applied -if the woman demands it- or after delivery, assessed up to 10 hours from intervention's start).
Secondary	TENS satisfaction	Self reported interest on use of TENS on future deliveries. Score 0-10 (0 = no way, 10 = absolutely necessary)	At leaving the labor room, assessed up to 3 hours after delivery.