Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (Medical and Economical Assessment)
GAME
1 other identifier
interventional
200
1 country
1
Brief Summary
Pelvic girdle and low back pain are common in pregnancy, and cause severe impairment in 10% of women. Our hypothesis is that offering acupuncture in addition to standard care would reduce pain and impairment throughout pregnancy. 300 pregnant women from 5 maternity units will be randomized over a 3 year period to receive standard care or standard care plus acupuncture. Main outcome will be the number of days during pregnancy with maximum pain ≤ 4/10. Secondary outcomes will compare groups for an impairment score and for direct and indirect costs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 6, 2013
CompletedFirst Posted
Study publicly available on registry
May 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMay 29, 2019
June 1, 2014
2.5 years
March 6, 2013
May 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number and % of days during pregnancy with maximum pain ≤ 4/10.
daily recording on logbook (self assessment)
at 4 weeks
Secondary Outcomes (3)
Mean Oswestry disability score
during pregnancy
Number and % of days with maximum pain ≤ 4/10.
during pregnancy
direct and indirect costs
during pregnancy
Study Arms (2)
acupuncture
EXPERIMENTAL5 acupuncture sessions over a 4 week period plus standard treatment
usual care
ACTIVE COMPARATORstandard treatment (pregnancy belt, behavioral recommendations, exercises, pain killers as prescribed by usual health care professional)
Interventions
Eligibility Criteria
You may qualify if:
- singleton uncomplicated 16-34 weeks pregnancy, with PLBP \> 4/10
You may not qualify if:
- Obstetrical complication other than PLBP,
- contra indication to acupuncture,
- sciatica
- maternal age \< 18
- no health insurance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre d'Investigation Clinique Paris Est - Hôpital Pitié Salpêtrière
Paris, 75013, France
Related Publications (1)
Nicolian S, Butel T, Gambotti L, Durand M, Filipovic-Pierucci A, Mallet A, Kone M, Durand-Zaleski I, Dommergues M. Cost-effectiveness of acupuncture versus standard care for pelvic and low back pain in pregnancy: A randomized controlled trial. PLoS One. 2019 Apr 22;14(4):e0214195. doi: 10.1371/journal.pone.0214195. eCollection 2019.
PMID: 31009470RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Dommergues, Md, PhD
APHP
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2013
First Posted
May 7, 2013
Study Start
September 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
May 29, 2019
Record last verified: 2014-06