ABSTRACT
BACKGROUND: Two-thirds of pregnant women suffer from low-back pain during pregnancy, which leads to negative effects on quality of everyday life. According to the literature, an 8- to 12-week program of adapted physical activity during pregnancy has proven its efficacy in treatment of low-back pain and functional disability. Stretching Postural is a nondynamic technique using muscular contractions and stretches that act mainly on the back and that can be practiced alone. OBJECTIVE: This study aimed to assess the effect of an 8-week program of standardized Stretching Postural postures in low-risk pregnant women suffering from low-back pain. STUDY DESIGN: This was an open-label, randomized, controlled trial in 1 French university hospital. Women with a singleton low-risk pregnancy between 15 and 32 weeks of gestation and with back, lumbar, or sacroiliac pain were randomly assigned (1:1) to either undergo an 8-week program of standardized Stretching Postural with basic advice (intervention group) or to receive basic advice only (control group). Both groups received ergonomic advice and encouragement to practice physical activity. The primary endpoint was the pain assessment at 8 weeks (defined by the mean pain level estimated by women in the previous week, scored on a numeric scale from 0 to 10). Secondary endpoints were pain after 4 weeks of follow-up, quality of life (12-item Short Form Survey), satisfaction (Patient Global Impression of Change), and delivery outcomes. The main analysis was intention-to-treat. RESULTS: From January 2019 to August 2020, 60 women were randomized: 30 were assigned to the intervention group and 30 to the control group. The mean level of pain at 8 weeks was significantly lower in the intervention group than in the control group (1.6±1.4 vs 4.1±2.2; P<.01). The mean 12-item Short Form Survey scores were significantly higher in the posture group than in the control group (Physical Component Score, 45.7±7.8 vs 37.4±8.5; P<.01; Mental Component Score, 54.3±5.8 vs 50.4±7.1; P=.04), and the Patient Global Impression of Change score was also significantly higher (6.1±1.5 vs 3.9±2.3; P<.01). No adverse effects were found. CONCLUSION: Stretching Postural appears to be a safe and efficient nondrug therapy to treat low-back pain during low-risk pregnancy.
ABSTRACT
ABSTRACT: Nitrous oxide (N2O) is an odorless and colorless gas routinely used as an adjuvant of anesthesia and for short-duration analgesia in various clinical settings mostly in the form of an N2O/O2 50%-50% equimolar mixture (EMONO). Experimental studies have suggested that EMONO could also induce long-lasting analgesic effects related to the blockade of N-methyl-D-aspartate receptors. We designed the first international multicenter proof of concept randomized, placebo-controlled study to assess the efficacy and safety of a 1-hour administration of EMONO or placebo (medical air) on 3 consecutive days up to 1 month after the last administration in patients with chronic peripheral neuropathic pain. A total of 240 patients were recruited in 22 centers in France and Germany and randomly assigned to 1 study group (120 per group). Average pain intensity (primary outcome), neuropathic pain characteristics (Neuropathic Pain Symptom Inventory), Patient Global Impression of Change, anxiety, depression, and quality of life were systematically assessed before and after treatment. The changes in average pain intensity between baseline and 7 days after the last administration were not significantly different between the 2 groups. However, evoked pain intensity (predefined secondary endpoint) and Patient Global Impression of Change (exploratory endpoint) were significantly improved in the EMONO group, and these effects were maintained up to 4 weeks after the last treatment administration. Mostly transient side effects were reported during the treatment administration. These encouraging results provide a basis for further investigation of the long-term analgesic effects of EMONO in patients with neuropathic pain.
