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

Disorder of Pregnancy Clinical Trial

— GAME  

Official title:

Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (TAPPP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848587
• Other study ID #: P111001
• Status: Completed
• Phase: Phase 3
• Start date: September 2012
• Est. completion date: March 2015

Study information

• Verified date: June 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Disorder of Pregnancy
• Low Back Pain

Intervention

Other:
• acupuncture

• usual care

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique Paris Est - Hôpital Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and % of days during pregnancy with maximum pain = 4/10.	daily recording on logbook (self assessment)	at 4 weeks
Secondary	Mean Oswestry disability score		during pregnancy
Secondary	Number and % of days with maximum pain = 4/10.		during pregnancy
Secondary	direct and indirect costs	direct costs related to pregnancy care and pain management, indirect costs related to impairment throughout pregnancy and the immediate postpartum.	during pregnancy