NCT01197950

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
10.6 years until next milestone

Results Posted

Study results publicly available

June 6, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

2.8 years

First QC Date

August 26, 2010

Results QC Date

April 25, 2020

Last Update Submit

September 7, 2022

Conditions

Labour Pain

Keywords

acupuncturelabourpainpain reliefcomplementary

Outcome Measures

Primary Outcomes (1)

  • Use of Epidural Analgesia

    Frequecy of epidural analgesia

    From start of treatment until birth

Study Arms (3)

Manual Acupuncture

ACTIVE COMPARATOR

Manual stimulation

Device: Manual Acupuncture

Electro Acupuncture

EXPERIMENTAL

Electrical and manual stimulation

Device: Electro Acupuncture

Standard care

NO INTERVENTION

No acupunture

Interventions

Manual AcupunctureDEVICE

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.

Also known as: Acupuncture
Manual Acupuncture
Electro AcupunctureDEVICE

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.

Also known as: Acupuncture
Electro Acupuncture

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Severe preeclampsia
  • Treatment with oxytocin at the time point of allocation
  • Treatment with anticoagulant
  • Pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Life Sciences, University of Skövde

Skövde, SE-541 28, Sweden

Location

Related Publications (4)

  • Vixner L, Martensson 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.

    PMID: 26066641BACKGROUND

  • Vixner L, Martensson 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.

    PMID: 22577468BACKGROUND

  • Vixner L, Schytt E, Martensson 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.

    PMID: 27986648BACKGROUND

  • Vixner L, Schytt E, Stener-Victorin E, Waldenstrom U, Pettersson H, Martensson 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.

    PMID: 24913704BACKGROUND

MeSH Terms

Conditions

Labor PainPain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Results Point of Contact

Title
Professor Lena Mårtensson
Organization
Universty of Skovde
lena.martensson@his.se
+46500448000

Study Officials

  • Lena B Martensson, PhD

    University of Skövde

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD RNM Senior Lecturer

Study Record Dates

First Submitted

August 26, 2010

First Posted

September 9, 2010

Study Start

October 1, 2008

Primary Completion

August 1, 2011

Study Completion

November 1, 2011

Last Updated

September 21, 2022

Results First Posted

June 6, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)