Clinical trial NCT01848587: Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (Medical and Economical Assessment)
Official title: Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (TAPPP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Disorder of Pregnancy
Keywords: Pregnancy
Acupuncture
Pelvic and low back pain
Impairment
Economic evaluation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Background. Pelvic and low back pain (PLBP) affects 30% of pregnant women for weeks or months, causing severe impairment in 10% of women. Standard treatment, based on pain killers, postural recommendations, exercises, is of limited value. Previous trials showed that adding acupuncture to standard treatment reduces pain and impairment in the short run.

Hypothesis Providing acupuncture to pregnant women with PLBP could reduce pain and impairment throughout pregnancy, thus reducing other direct and indirect cots related to PLBP.

Primary Outcome. Number and % of days during pregnancy with maximum pain ≤ 4/10.

Secondary Outcomes. Pain scale 4 weeks after inclusion, mean Oswestry disability score between inclusion and delivery, direct costs related to pregnancy care and pain management, indirect costs related to impairment throughout pregnancy and the immediate postpartum.

Method. Multicenter randomized trial with parallel groups. Intervention: 5 acupuncture sessions over 4 weeks, plus standard treatment. Controls: standard treatment.

Analysis per pregnancy Follow up: logbook kept by he patient plus analysis of obstetrical records. Number of patients: 300 Inclusion criteria: singleton uncomplicated 16-34 weeks pregnancy, with PLBP \> 4/10 Exclusion criteria Obstetrical complication other than PLBP, contra indication to acupuncture, sciatica, maternal age \< 18, no health insurance.

Duration. Overall duration: 3 years and 6 months, inclusions over 3 years. Duration of inclusion per patient: 2-26 weeks Number of participating centers 5

Eligibility criteria: Inclusion Criteria:

* singleton uncomplicated 16-34 weeks pregnancy, with PLBP \> 4/10

Exclusion Criteria:

* Obstetrical complication other than PLBP,
* contra indication to acupuncture,
* sciatica
* maternal age \< 18
* no health insurance.

Primary outcomes:
measure: Number and % of days during pregnancy with maximum pain ≤ 4/10.
timeFrame: at 4 weeks
Secondary outcomes:
measure: Mean Oswestry disability score
timeFrame: during pregnancy
measure: Number and % of days with maximum pain ≤ 4/10.
timeFrame: during pregnancy
measure: direct and indirect costs
timeFrame: during pregnancy
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique Paris Est - Hôpital Pitié Salpêtrière
Study officials:
affiliation: APHP
name: Marc Dommergues, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.