Dataset Information

Influence of unstable shoes on women with lumbopelvic postpartum pain: randomized clinical trial.

ABSTRACT:

Background

Back pain is a normal symptom during pregnancy and is expected to become worse beyond the first three months after childbirth.

Objectives

To determine the effectiveness of wearing unstable shoes instead of conventional shoes, regarding pain intensity, low back mobility and stability, among women with lumbopelvic pain (LPP) during the postpartum period.

Design and setting

Prospective, single-blinded, randomized clinical trial conducted at a podiatry and physiotherapy clinical center.

Methods

A nine-week program of wearing either unstable shoes (A) or conventional shoes (B) was implemented. The following outcomes were measured in three assessments: pain intensity, using a visual analogue scale (VAS); low-back mobility, using a modified Schober test; and stability, using a pressure platform.

Results

The lateral stability speed, anterior stability speed and anterior center of pressure (COP) showed significant (P < 0.05) decreases in the unstable shoes group after nine weeks, in relation to the conventional group. Intra-group measurements showed significant differences (P < 0.05) in VAS between the second and third assessments and between the first and third assessments in both groups. Intra-group evaluations also showed statistically significant differences (P < 0.05) in the lateral stability speed and anterior stability speed.

Conclusions

Unstable shoes were effective in decreasing the pain intensity at five and nine weeks in women with postpartum LPP. In addition, their use produced decreases in lateral stability speed, anterior stability speed and anterior COP at nine weeks.

SUBMITTER: Diaz-Meco Conde R

PROVIDER: S-EPMC9615595 | biostudies-literature | 2021 Jul-Aug

REPOSITORIES: biostudies-literature

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Publications

Influence of unstable shoes on women with lumbopelvic postpartum pain: randomized clinical trial.

Díaz-Meco Conde Raquel R Ruiz Ruiz Beatriz B Ruiz Ruiz Beatriz B Rubio Alonso Margarita M Calvo-Lobo César C de Labra Carmen C López-López Daniel D Romero Morales Carlos C

Sao Paulo medical journal = Revista paulista de medicina 20210701 4

<h4>Background</h4>Back pain is a normal symptom during pregnancy and is expected to become worse beyond the first three months after childbirth.<h4>Objectives</h4>To determine the effectiveness of wearing unstable shoes instead of conventional shoes, regarding pain intensity, low back mobility and stability, among women with lumbopelvic pain (LPP) during the postpartum period.<h4>Design and setting</h4>Prospective, single-blinded, randomized clinical trial conducted at a podiatry and physiother ...[more]

PMID: 34161523

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Project description:BackgroundLumbopelvic pain (LPP) is common during pregnancy and can have long-lasting negative consequences in terms of disability and reduced quality of life. Therefore, it is crucial to identify women at risk of having pregnancy-related LPP after childbirth. This study aimed to investigate the association between body perception, pain intensity, and disability in women with pregnancy-related LPP during late pregnancy and postpartum, and to study whether a disturbed body perception during late pregnancy predicted having postpartum LPP.MethodsA prospective cohort study in 130 primiparous women (median age = 30 years) was performed. Pain intensity, disability, and lumbopelvic body perception during the last month of pregnancy and 6 weeks postpartum were assessed with the Numerical Pain Rating Scale (NPRS), Oswestry Disability Index, and Fremantle Back Awareness Questionnaire, respectively. Having pregnancy-related LPP was defined as an NPRS score ≥ 1/10. At both timepoints, women were categorized into three groups; pain-free, LPP with low disability, and LPP with high disability (based on Oswestry Disability Index scores). At each timepoint, body perception was compared between groups, and correlations between body perception, pain intensity, and disability were evaluated in women with LPP by using non-parametric tests. Logistic regression analysis was used to determine whether body perception during the last month of pregnancy predicted the presence of LPP 6 weeks postpartum.ResultsWomen with LPP at the end of pregnancy, and 6 weeks postpartum reported a more disturbed body perception compared to pain-free women (p ≤ 0.005). Greater body perception disturbance correlated with higher pain intensity (σ = 0.266, p = 0.008) and disability (σ = 0.472, p < 0.001) during late pregnancy, and with pain intensity 6 weeks postpartum (σ = 0.403, p = 0.015). A disturbed body perception during late pregnancy nearly significantly predicted having postpartum LPP (Odds Ratio = 1.231, p = 0.052).ConclusionsBody perception disturbance was greater in women experiencing LPP during late pregnancy and postpartum compared to pain-free women, and correlated with pain intensity and disability. Though non-significant (p = 0.052), the results of the regression analysis suggest that greater body perception disturbance during late pregnancy might predict having LPP postpartum. However, future studies should follow up on this.

Project description:BackgroundAbout 50% of women experience lumbopelvic pain (LBPP) during their pregnancy. LBPP has negative repercussions on sleep, social and sexual life, physical and work capacity, and psychological health and contributes to physical inactivity. The benefits of LBPP prevention or treatment in pregnant women through specific exercises should therefore be further investigated. This study protocol has been designed to establish the feasibility of implementing motor control exercise program with pregnant women presenting with a history of LBPP.Methods/designForty pregnant women with a history of LBPP will be recruited and randomly allocated to a control (20 participants) or intervention (20 participants) group. The control group will receive standard prenatal care, including basic information on what to do when suffering from LBPP. The intervention group will participate in three 40-min exercise sessions per week from < 20 weeks until 34-36 weeks of gestation: one supervised group session via the Zoom platform (once a month, this session will take place at the Université du Québec à Trois-Rivières) and two unsupervised sessions at home. A motor control exercise program will be developed to target strengthening of the lumbo-pelvic-hip core muscles and improve spinal and pelvic stabilization. Participants of this group will also receive standard prenatal care. Women of the control group will receive after 6 weeks postpartum an exercise program designed to reduce LBPP they may have developed during pregnancy and that may persist after delivery. Primary outcomes will be participants' recruitment, retention and adherence rates, safety, and acceptability of the intervention. Secondary outcomes will include LBPP incidence, frequency, and intensity, as well as self-reported functional disability, physical activity levels, fear avoidance behavior, anxiety, and depression.DiscussionThis study will inform the feasibility of conducting a full-scale randomized controlled study to test the effectiveness of a motor control exercise program on the prevention and treatment of LBPP in women with a history of LBPP. Adequate prevention and treatment of pregnant women with a history of LBPP should help limit the recurrences of LBPP or the aggravation of its intensity during pregnancy.Trial registrationUS National Institutes of Health Clinical Trials registry NCT04253717 April 27, 2021.

Project description:ImportanceEsketamine has been found to reduce the incidence of postpartum depression (PPD) in randomized clinical trials. However, current evidence from randomized clinical trials does not reflect esketamine's efficacy in clinical settings.ObjectiveTo assess the clinical efficacy of intraoperative esketamine administration for preventing PPD among women who underwent cesarean delivery.Design, setting, and participantsThis randomized clinical trial was conducted at The First Affiliated Hospital of Chongqing Medical University in Chongqing, China, from March 2023 to February 2024. Pregnant patients admitted for cesarean delivery were included, while those with intellectual dysfunction or contraindications to esketamine were excluded. All participants were assigned randomly to either the esketamine group or control group in a 1:1 ratio. Data analysis was based on the intention-to-treat principle.InterventionsPatients in the esketamine group received an infusion of 0.25 mg/kg esketamine in 20 mL of saline over 20 minutes, whereas patients in the control group received 20 mL saline over 20 minutes.Main outcomes and measuresThe primary outcome was the incidence of PPD at 6 weeks post partum. PPD was assessed using the Edinburgh Postnatal Depression Scale.ResultsA total of 308 pregnant women were randomly assigned to 1 of 2 groups: esketamine (n = 154; mean [SD] patient age, 31.57 [4.26] years) and control (n = 154; mean [SD] patient age, 32.53 [7.74] years). Incidence of PPD was significantly lower in the esketamine group compared with the control group at 6 weeks post partum (10.4% [16] vs 19.5% [30]; relative risk, 0.53; 95% CI, 0.30-0.93; P = .02).Conclusions and relevanceThis randomized clinical trial demonstrated esketamine's advantage in reducing the incidence of PPD at 6 weeks post partum in patients who underwent cesarean delivery. The efficacy and safety of esketamine in preventing PPD warrant further investigation in clinical practice.Trial registrationChinese Clinical Trial Registry Identifier: ChiCTR2200065494.

Project description:BackgroundChronic low back pain is a common problem and is associated with high costs, including those related to health care and indirect costs due to absence at work or reduced productivity. Previous studies have demonstrated that acupuncture or electroacupuncture can relieve low back pain. Electronic acupuncture shoes (EAS) are a novel device designed in this study. This device combines the properties of acupuncture and transcutaneous electrical nerve stimulation for clinical use.ObjectiveThe aim of this study was to evaluate the efficacy of EAS in patients with chronic low back pain.MethodsIn this prospective double-blinded randomized controlled study, the data of 83 patients who experienced chronic low back pain were analyzed. Patients came to our clinic for 20 visits and underwent assessment and treatment. Patients were randomly allocated to receive either EAS plus placebo nonsteroidal anti-inflammatory drugs (NSAIDs) (EAS group, n=42) or sham EAS plus NSAIDs (NSAID group, n=41). The visual analog scale (VAS) score and range of motion were assessed at baseline, before and after each EAS treatment, and 2 weeks after the last treatment. The time for achieving pain remission was recorded. Quality of life was assessed at the 2nd, 14th, and 20th visits.ResultsAfter 6 weeks of treatment, the treatment success rate in each visit in the EAS group was higher than that in the NSAID group, as revealed by the intention-to-treat (ITT) and per-protocol (PP) analyses, but significant differences were observed only during the 16th visit in the ITT analysis (EAS group: 31/37, 84% and NSAID group: 21/34, 62%; P=.04). The change in the VAS score from baseline in each visit in the EAS group was greater than that in the NSAID group, as revealed by the ITT and PP analyses, and significant differences were observed in the 5th visit and 9th visit in the ITT analysis (P=.048 and P=.048, respectively). Significant differences were observed in the left rotation in the 2nd visit and 4th visit (P=.049 and P=.03, respectively). No significant differences were observed in the VAS score before and after treatment in each visit and in the quality of life in both groups.ConclusionsEAS might serve as a reliable alternative therapeutic tool for patients with chronic low back pain who are contraindicated for oral NSAIDs.Trial registrationClinicalTrials.gov NCT02468297 https://clinicaltrials.gov/ct2/show/NCT02468297.

Project description:ImportancePostpartum depression (PPD) is emerging as a major public health problem worldwide. Although the particular period and context in which PPD occurs provides an opportunity for preventive interventions, there is still a lack of pharmacologic prevention strategies for PPD.ObjectiveTo assess the efficacy and safety of dexmedetomidine for prevention of PPD among women with prenatal depression undergoing cesarean delivery.Design, setting, and participantsThis randomized clinical trial enrolled 338 women who screened positive for prenatal depression at 2 hospitals in Hunan, China from March 28, 2022, to April 16, 2023. Women with an Edinburgh Postnatal Depression Scale score of more than 9 who were 18 years of age or older and were scheduled for elective cesarean delivery were eligible.InterventionsEligible participants were randomly assigned in a 1:1 ratio to either the dexmedetomidine group or the control group via centrally computer-generated group randomization. Dexmedetomidine, 0.5 μg/kg and 0.9% saline were intravenously infused for 10 minutes after delivery in the dexmedetomidine and control groups, respectively. After infusion, sufentanil or dexmedetomidine plus sufentanil was administered via patient-controlled intravenous analgesia for 48 hours in the control group and dexmedetomidine group, respectively.Main outcomes and measuresThe primary outcome was positive PPD screening results at 7 and 42 days post partum, defined as a postpartum Edinburgh Postnatal Depression Scale score of more than 9. Analysis was on an intention-to-treat basis.ResultsAll 338 participants were female, with a mean (SD) age of 31.5 (4.1) years. Positive PPD screening incidence at 7 and 42 days post partum in the dexmedetomidine group vs the control group was significantly decreased (day 7, 21 of 167 [12.6%] vs 53 of 165 [32.1%]; risk ratio, 0.39 [95% CI, 0.25-0.62]; P < .001; day 42, 19 of 167 [11.4%] vs 50 of 165 [30.3%]; risk ratio, 0.38 [95% CI, 0.23-0.61]; P < .001). The dexmedetomidine group showed no significant difference in adverse events vs the control group (46 of 169 [27.2%] vs 33 of 169 [19.5%]; P = .10), but the incidence of hypotension increased (31 of 169 [18.3%] vs 16 of 169 [9.5%]; risk ratio, 2.15 [95% CI, 1.13-4.10]; P = .02).Conclusions and relevanceDexmedetomidine administration in the early postpartum period significantly reduced the incidence of a positive PPD screening and maintained a favorable safety profile.Trial registrationChinese Clinical Trial Registry Identifier: ChiCTR2200057213.

Project description:ImportanceMost women who quit smoking during pregnancy will relapse postpartum. Previous efforts to prevent postpartum relapse have been unsuccessful at increasing rates of sustained abstinence.ObjectiveTo evaluate the relative efficacy of 2 different approaches to prevent postpartum smoking relapse.Design, setting, and participantsPregnant women who recently had quit smoking were recruited before the end of pregnancy. Intervention sessions were conducted through a combination of telephone calls and in-person visits beginning at delivery and continuing through 24 weeks postpartum. Participants completed assessments at the prenatal baseline and at 12, 24, and 52 weeks postpartum. Participants were recruited between March 2008 and December 2012. The dates of the analysis were April 2014 to February 2015.InterventionsWomen received postpartum-adapted, behavioral smoking relapse prevention intervention and were randomly assigned to an enhanced cognitive behavioral intervention that included additional specialized strategies and content focused on women's postpartum concerns about mood, stress, and weight (Strategies to Avoid Returning to Smoking [STARTS]) or a supportive, time and attention-controlled comparison (SUPPORT). Intervention began before delivery and continued through 24 weeks postpartum.Main outcomes and measuresThe primary outcome was biochemically confirmed sustained tobacco abstinence at 52 weeks postpartum. Secondary outcomes were self-reported mood, levels of perceived stress, and degree of concern about smoking-related weight gain.ResultsThe study cohort comprised 300 participants (150 randomly assigned to each group). Their mean (SD) age was 24.99 (5.65) years. Overall, 38.0% (114 of 300), 33.7% (101 of 300), and 24.0% (72 of 300) of the sample maintained abstinence at 12, 24, and 52 weeks' postpartum, respectively. There were no differences between the intervention groups in abstinence or time to relapse. Self-reported depressive symptoms and perceived stress significantly improved over time, and improvements were similar for both intervention groups. Women with more depressive symptoms and higher levels of perceived stress were more likely to relapse (hazard ratio, 1.02; 95% CI, 1.00-1.04; P = .04 for depressive symptoms and hazard ratio, 1.04; 95% CI, 1.01-1.07; P = .003 for stress).Conclusions and relevanceAn intervention designed to address women's concerns about mood, stress, and weight did not differentially improve rates of sustained tobacco abstinence postpartum compared with a time and attention-controlled comparison. Women in STARTS and SUPPORT reported postpartum improvements in mood and stress, and the experience of fewer depressive symptoms and less perceived stress was related to sustained abstinence. Given that most pregnant quitters will relapse within 1 year postpartum and that postpartum smoking has negative health consequences for women and children, effective interventions that target postpartum mood and stress are needed.Trial registrationclinicaltrials.gov Identifier: NCT00757068.

Dataset Information

Influence of unstable shoes on women with lumbopelvic postpartum pain: randomized clinical trial.

Background

Objectives

Design and setting

Methods

Results

Conclusions

Publications

Influence of unstable shoes on women with lumbopelvic postpartum pain: randomized clinical trial.

Similar Datasets

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