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

NCT ID: NCT01848587

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-03-31

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

Conditions

Disorder of Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

acupuncture

5 acupuncture sessions over a 4 week period plus standard treatment

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: OTHER

usual care

standard treatment (pregnancy belt, behavioral recommendations, exercises, pain killers as prescribed by usual health care professional)

Group Type: ACTIVE_COMPARATOR

usual care

Intervention Type: OTHER

Interventions

acupuncture

Intervention Type: OTHER

usual care

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Dommergues, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Centre d'Investigation Clinique Paris Est - Hôpital Pitié Salpêtrière

Paris, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 31009470 (View on PubMed)

Other Identifiers

P111001

Identifier Type: -

Identifier Source: org_study_id