Gemalodo study

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GEMALODO STUDY ABSTRACT

Standardized Stretching Postural® postures to care low-back pain in pregnancy: the GEMALODO randomized clinical trial.

Background: Two thirds of pregnant women suffer from low-back pain during pregnancy with negative impacts on the quality of their personal, professional and family life. According to the literature, an 8 to 12-weeks program of adequate physical exercises during pregnancy has proven its efficiency on low-back-pain and functional disability. Stretching Postural® is a non-dynamic technic using muscular contractions and stretches acting mainly on the back that can be practiced alone.

Objective: The aim of the study was to evaluate if an 8-weeks program of standardized Stretching Postural® auto-postures in low-risk pregnant women is associated with a decrease of low-back pain.

Study design: We conducted an open-label, randomized controlled trial in one French hospital. Women with a singleton low-risk pregnancy between 15 and 32 weeks of gestation, with back, lumbar, or sacroiliac pain. Women were randomly assigned (1:1) to either undergo an 8-weeks program of standardized Stretching Postural® (intervention group) or no such program (control group). Both groups received ergonomic tips and encouragement to practice sport. We recorded maternal pain during the past week on a scale from 0 to 10 at 8 weeks as the primary outcome. Secondary outcomes were pain after 4 weeks, quality of life, satisfaction, and delivery outcomes. The main analysis was focus on intention-to-treat analysis.

Results: From January 2019 to August 2020, 60 women were randomized: 30 were assigned to the intervention group, 30 to the control group. The average pain intensity in the past week was significantly lower at 8 weeks in the posture group compared to the control group (1.6+/-1.4 vs 4.1+/-2.2, p<0.01). The SF-12 score was also significantly higher in the posture group (PCS 45.7+/-7.8 vs 37.4+/-8.5, p<0.01 and MCS 54.3+/-5.8 vs 50.4+/-7.1, p=0.04) and the PGIC satisfaction score was significantly higher (6.1+/-1.5 vs 3.9+/-2.3, p<0.01). No adverse effects were described.

Conclusion: Stretching Postural® appears to be a safe and efficient solution to care for low-back pain during low-risk pregnancy.

KEYWORDS: Low-back pain, pregnancy, physical activity, prevention, sport, care, Stretching Postural®

AUTHORS : 

Magalie Barbier (1) magalie.barbier[@]ap-hm.fr, Julie Blanc (1,2), Cindy Faust (2), Karine Baumstarck (2), Stephanie Ranque-Garnier (3,4), Florence Bretelle (1,5,6).

(1) Department of Obstetrics and Gynecology, Nord Hospital, Assistance Publique – Hopitaux de Marseille (AP-HM), Aix Marseille University (AMU), Marseille, France.
(2) EA 3279, CEReSS, Health Service Research and Quality of Life Center, Aix-Marseille University (AMU), Marseille, France.
(3) CETD CHU Timone, Assistance Publique – Hopitaux de Marseille (APHM), Marseille France.
(4) UMR 7249, CNRS, Centrale Marseille, Institut Fresnel, Aix Marseille Université (AMU), France.
(5) Inserm 1095, URMITE, Aix-Marseille University (AMU), UM 63, CNRS 7278, IRD 198, Institut Hospitalo-Universitaire-Méditerranée Infection, 19-21, boulevard Jean Moulin, 13385 Marseille cedex 05, France.
(6) Department of Obstetrics and Gynecology, Conception Hospital, Assistance Publique – Hopitaux de Marseille (AP-HM), Marseille, France; Aix Marseille University (AMU), Marseille, France.

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