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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Disorder of Pregnancy	Other: acupuncture; Other: usual care	Phase 3

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (TAPPP)
Study Start Date :	September 2012
Actual Primary Completion Date :	March 2015
Actual Study Completion Date :	March 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: acupuncture; 5 acupuncture sessions over a 4 week period plus standard treatment	Other: acupuncture
Active Comparator: usual care; standard treatment (pregnancy belt, behavioral recommendations, exercises, pain killers as prescribed by usual health care professional)	Other: usual care

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Number and % of days during pregnancy with maximum pain ≤ 4/10. [ Time Frame: at 4 weeks ]
   daily recording on logbook (self assessment)

Secondary Outcome Measures :

1. Mean Oswestry disability score [ Time Frame: during pregnancy ]
2. Number and % of days with maximum pain ≤ 4/10. [ Time Frame: during pregnancy ]
3. direct and indirect costs [ Time Frame: during pregnancy ]
   direct costs related to pregnancy care and pain management, indirect costs related to impairment throughout pregnancy and the immediate postpartum.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Centre d'Investigation Clinique Paris Est - Hôpital Pitié Salpêtrière
Paris, France, 75013

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:	Marc Dommergues, Md, PhD	APHP

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT01848587 History of Changes
Other Study ID Numbers:	P111001
First Posted:	May 7, 2013
Last Update Posted:	May 13, 2015
Last Verified:	June 2014

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Pregnancy; Acupuncture; Pelvic and low back pain; Impairment; Economic evaluation

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain	Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms