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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01848587
First received: March 6, 2013
Last updated: June 13, 2014
Last verified: June 2014

March 6, 2013
June 13, 2014
September 2012
October 2015   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01848587 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (Medical and Economical Assessment)
Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (TAPPP)

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Disorder of Pregnancy
  • Other: acupuncture
  • Other: usual care
  • Experimental: acupuncture
    5 acupuncture sessions over a 4 week period plus standard treatment
    Intervention: Other: acupuncture
  • Active Comparator: usual care
    standard treatment (pregnancy belt, behavioral recommendations, exercises, pain killers as prescribed by usual health care professional)
    Intervention: Other: usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
October 2015
October 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact: Marc Dommergues, MD, PhD marc.dommergues@psl.aphp.fr
France
 
NCT01848587
P111001
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Marc Dommergues, Md, PhD APHP
Assistance Publique - Hôpitaux de Paris
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP