Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (Medical and Economical Assessment) (GAME)
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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) |
- 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)
- 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.
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 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 |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01848587
| Contact: Marc Dommergues, MD, PhD | marc.dommergues@psl.aphp.fr |
| France | |
| Centre d'Investigation Clinique Paris Est - Hôpital Pitié Salpêtrière | Recruiting |
| Paris, France, 75013 | |
| Contact: Stéphanie Nicollian | |
| Principal Investigator: Marc Dommergues, MD, PhD | |
| Principal Investigator: | Marc Dommergues, Md, PhD | APHP |
More Information
No publications provided
| 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: | June 13, 2014 |
| 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:
|
Low Back Pain Back Pain Nervous System Diseases |
Neurologic Manifestations Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on February 27, 2015