Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (Medical and Economical Assessment) - Full Text View

Purpose

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	Intervention	Phase
Disorder of Pregnancy	Other: acupuncture Other: usual care	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (TAPPP)

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Back Pain

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Number and % of days during pregnancy with maximum pain ≤ 4/10. [ Time Frame: at 4 weeks ] [ Designated as safety issue: No ]
daily recording on logbook (self assessment)

Secondary Outcome Measures:

Mean Oswestry disability score [ Time Frame: during pregnancy ] [ Designated as safety issue: No ]
Number and % of days with maximum pain ≤ 4/10. [ Time Frame: during pregnancy ] [ Designated as safety issue: No ]
direct and indirect costs [ Time Frame: during pregnancy ] [ Designated as safety issue: No ]
direct costs related to pregnancy care and pain management, indirect costs related to impairment throughout pregnancy and the immediate postpartum.


Enrollment:	200
Study Start Date:	September 2012
Study Completion Date:	March 2015
Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848587

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


Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT01848587 History of Changes
Other Study ID Numbers:	P111001
Study First Received:	March 6, 2013
Last Updated:	May 12, 2015
Health Authority:	France: Ministry of Health

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

ClinicalTrials.gov processed this record on September 28, 2016

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