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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (TAPPP)

Conditions
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Disorder of Pregnancy

Intervention / Treatment
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* Other: acupuncture
* Other: usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and % of days during pregnancy with maximum pain ≤ 4/10. | daily recording on logbook (self assessment) | at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Oswestry disability score |  | during pregnancy | 
| Number and % of days with maximum pain ≤ 4/10. |  | during pregnancy | 
| direct and indirect costs | direct costs related to pregnancy care and pain management, indirect costs related to impairment throughout pregnancy and the immediate postpartum. | during pregnancy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Acupuncture, Pelvic and low back pain, Impairment, Economic evaluation