Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain

Labour Pain Clinical Trial

Official title:

A Randomized Controlled Trial of Acupuncture to Reduce Labour Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197950
• Other study ID #: 136-08
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: November 2011

Study information

• Verified date: September 2022
• Source: University of Skövde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of manual acupuncture and electro-acupuncture on labour pain.

Description:

Acupuncture is used in obstetric care in spite of insufficient evidence of its potential to reduce labour pain. The findings so far are contradictory, which may reflect methodological limitations. The present study will take issues into account, such as sufficiently large sample to allow detection of possible differences between study groups; optimal timing of the intervention; controlling for intensity of the treatment; qualified training of persons giving the treatment; biological markers of pain and stress; possible effects on mother and infant; women's experiences such as overall birth experience and memory of pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: November 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Admission to the labour ward in spontaneous onset of labour

• Latent or active phase of labour

• Nulliparity

• Singleton pregnancy, cephalic presentation

• Gestation: 37+0 to 41+6 (weeks + days)

• Expressed need for labour pain relief

• Swedish speaking (well enough to understand written and oral instructions)

Exclusion Criteria:

• No pharmacological pain relief within 24 hours prior to inclusion into the study

• Severe preeclampsia

• Treatment with oxytocin at the time point of allocation

• Treatment with anticoagulant

• Pacemaker

Related Conditions & MeSH terms

• Labor Pain
• Labour Pain

Intervention

Device:
• Manual Acupuncture
The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.
• Electro Acupuncture
The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.

Locations

Country	Name	City	State
Sweden	School of Life Sciences, University of Skövde	Skövde

Sponsors (1)

Lead Sponsor	Collaborator
University of Skövde

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Vixner L, Mårtensson LB, Schytt E. Acupuncture with manual and electrical stimulation for labour pain: a two month follow up of recollection of pain and birth experience. BMC Complement Altern Med. 2015 Jun 12;15:180. doi: 10.1186/s12906-015-0708-2. — View Citation

Vixner L, Mårtensson LB, Stener-Victorin E, Schytt E. Manual and electroacupuncture for labour pain: study design of a longitudinal randomized controlled trial. Evid Based Complement Alternat Med. 2012;2012:943198. doi: 10.1155/2012/943198. Epub 2012 Apr 17. — View Citation

Vixner L, Schytt E, Mårtensson LB. Associations between maternal characteristics and women's responses to acupuncture during labour: a secondary analysis from a randomised controlled trial. Acupunct Med. 2017 Jun;35(3):180-188. doi: 10.1136/acupmed-2016-011164. Epub 2016 Dec 16. — View Citation

Vixner L, Schytt E, Stener-Victorin E, Waldenström U, Pettersson H, Mårtensson LB. Acupuncture with manual and electrical stimulation for labour pain: a longitudinal randomised controlled trial. BMC Complement Altern Med. 2014 Jun 9;14:187. doi: 10.1186/1472-6882-14-187. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of Epidural Analgesia	Frequecy of epidural analgesia	From start of treatment until birth