Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (Medical and Economical Assessment) (GAME)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01848587|
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : May 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Disorder of Pregnancy||Other: acupuncture Other: usual care||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (TAPPP)|
|Study Start Date :||September 2012|
|Primary Completion Date :||March 2015|
|Study Completion Date :||March 2015|
5 acupuncture sessions over a 4 week period plus standard treatment
Active Comparator: usual care
standard treatment (pregnancy belt, behavioral recommendations, exercises, pain killers as prescribed by usual health care professional)
|Other: usual care|
- Number and % of days during pregnancy with maximum pain ≤ 4/10. [ Time Frame: at 4 weeks ]daily recording on logbook (self assessment)
- Mean Oswestry disability score [ Time Frame: during pregnancy ]
- Number and % of days with maximum pain ≤ 4/10. [ Time Frame: during pregnancy ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848587
|Centre d'Investigation Clinique Paris Est - Hôpital Pitié Salpêtrière|
|Paris, France, 75013|
|Principal Investigator:||Marc Dommergues, Md, PhD||APHP|