Labour PainNCT01197950
Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain
A study testing Manual Acupuncture and Electro Acupuncture in people with Labour Pain, run by University of Skövde at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the effect of manual acupuncture and electro-acupuncture on labour pain. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Labour Pain
- What is being tested?
- Manual Acupuncture and Electro Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2008to Nov 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Acupuncture to Reduce Labour Pain
The purpose of this study is to evaluate the effect of manual acupuncture and electro-acupuncture on labour pain.
Read the 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.
- Conditions
- Labour Pain
- Being tested
- Manual Acupuncture, Electro Acupuncture
- Keywords
- acupuncture, labour, pain, pain relief, complementary
- Medical subject headings
- Labor Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual AcupunctureDevice
Also called 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 AcupunctureDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Manual Acupuncture | Active comparator | Manual stimulation Receives: Device: Manual Acupuncture |
| Electro Acupuncture | Experimental | Electrical and manual stimulation Receives: Device: Electro Acupuncture |
| Standard care | No intervention | No acupunture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Epidural Analgesia
Frequecy of epidural analgesia
Measured: From start of treatment until birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startOct 2008
- Primary completionAug 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Labour PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Skövde
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena B Martensson, University of Skövde
- Investigators
- Lena B Martensson, PhD, Principal investigator, University of Skövde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197950
- Sponsor's protocol ID
- 136-08
- Status last verified
- Sep 2022
- First submitted
- 26 Aug 2010
- Last updated
- 21 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26066641Vixner 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.
PubMed 22577468Vixner 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.
PubMed 27986648Vixner 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.
PubMed 24913704
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Acupuncture to Reduce Labour Pain
- ClinicalTrials.gov ID
- NCT01197950
- Acronym / sponsor ID
- 136-08
- Conditions
- Labour Pain
- Keywords
- acupuncture, labour, pain, pain relief, complementary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- University of SkövdeUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Posted 6 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of manual acupuncture and electro-acupuncture on labour pain.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual Acupuncture | Active comparator | Device: Manual AcupunctureManual stimulation |
| Electro Acupuncture | Experimental | Device: Electro AcupunctureElectrical and manual stimulation |
| Standard care | No intervention | –No acupunture |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual AcupunctureAlso: AcupunctureThe 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. | Device | Manual Acupuncture |
| Electro AcupunctureAlso: AcupunctureThe 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. | Device | Electro Acupuncture |
Primary outcome
Use of Epidural Analgesia
Time frame: From start of treatment until birth
Frequecy of epidural analgesia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26066641Vixner 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.
- Background: PubMed 22577468Vixner 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.
- Background: PubMed 27986648Vixner 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.
- Background: PubMed 24913704Vixner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena B Martensson, PhD principal investigator
University of Skövde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Acupuncture and Electro Acupuncture in people with Labour Pain, run by University of Skövde at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Epidural Analgesia (time frame: From start of treatment until birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01197950, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.