Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain

• ClinicalTrials.gov Identifier: NCT01197950
• Recruitment Status: Completed
• First Posted: September 9, 2010
• Last Update Posted: November 14, 2017
• Sponsor: University of Skövde
• Information provided by (Responsible Party): Lena B Martensson, University of Skövde

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Labour Pain	Device: Manual Acupuncture; Device: Electro Acupuncture	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 303 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of Acupuncture to Reduce Labour Pain
• Study Start Date: October 2008
• Actual Primary Completion Date: August 2011
• Actual Study Completion Date: November 2011

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Manual Acupuncture; Manual stimulation	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.; Other Name: Acupuncture
Experimental: Electro Acupuncture; Electrical and manual stimulation	Device: 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.; Other Name: Acupuncture
No Intervention: Standard care; No acupunture

Outcome Measures

Primary Outcome Measures :

1. Experience of labour pain [ Time Frame: From start of treatment until birth ]
   Pain relief effectiveness

Secondary Outcome Measures :

1. Use of epidural analgesia [ Time Frame: From start of treatment until birth ]
   Frequecy of epidural analgesia

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Sweden

School of Life Sciences, University of Skövde

Skövde, Sweden, SE-541 28

Sponsors and Collaborators

University of Skövde

Investigators

• Principal Investigator: Lena B Martensson, PhD; University of Skövde

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

• Responsible Party: Lena B Martensson, PhD RNM Senior Lecturer, University of Skövde
• ClinicalTrials.gov Identifier: NCT01197950 History of Changes
• Other Study ID Numbers: 136-08
• First Posted: September 9, 2010
• Last Update Posted: November 14, 2017
• Last Verified: November 2017

Keywords provided by Lena B Martensson, University of Skövde:

acupuncture; labour; pain; pain relief; complementary

Additional relevant MeSH terms:

Labor Pain; Pain; Neurologic Manifestations; Signs and Symptoms