Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (Medical and Economical Assessment)

Phase 3

Completed

• Conditions: Disorder of Pregnancy
• Interventions: Other: acupuncture; Other: usual care

• Registration Number: NCT01848587
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-07
• Status Verified: 2014-06
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2019-05-24
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture	acupuncture	5 acupuncture sessions over a 4 week period plus standard treatment
usual care	usual care	standard treatment (pregnancy belt, behavioral recommendations, exercises, pain killers as prescribed by usual health care professional)

Primary Outcome Measures

Name	Time	Method
Number and % of days during pregnancy with maximum pain ≤ 4/10.	at 4 weeks	daily recording on logbook (self assessment)

Secondary Outcome Measures

Name	Time	Method
Mean Oswestry disability score	during pregnancy
Number and % of days with maximum pain ≤ 4/10.	during pregnancy
direct and indirect costs	during pregnancy	direct costs related to pregnancy care and pain management, indirect costs related to impairment throughout pregnancy and the immediate postpartum.

Trial Locations

Locations (1)

Centre d'Investigation Clinique Paris Est - Hôpital Pitié Salpêtrière; 🇫🇷 Paris, France