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腰部支撑对产后骨盆带疼痛女性的疼痛、功能障碍及运动控制的疗效:一项随机对照试验方案

The Efficacy of Lumbar Support on Pain, Disability, and Motor Control in Women With Postpartum Pelvic Girdle Pain: Protocol for a Randomized Controlled Trial.

作者信息

Jafarian Fahimeh-Sadat, Jafari-Harandi Mahmonir, Yeowell Gillian, Sadeghi-Demneh Ebrahim

机构信息

Musculoskeletal Research Center, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.

Department of Obstetrics & Gynecology, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.

出版信息

JMIR Res Protoc. 2022 Jul 20;11(7):e40553. doi: 10.2196/40553.

Abstract

BACKGROUND

Pregnancy-related posterior pelvic girdle pain (PPGP) is one of the most important clinical manifestations of postpartum back pain. Those affected often complain of discomfort during daily activities. It is hypothesized that altered motor control is associated with perceived pain. Pelvic support can regulate possible underlying altered motor control mechanisms and decrease pain. However, the influence of a lumbosacral orthosis, which is broader support that allows for a wider contact area and more skin sensory stimulation to restore proper motor function, has not yet been investigated in women with postpartum PPGP.

OBJECTIVE

This study investigates the efficacy of broader lumbar support and narrower pelvic support on pain, proprioception, disability, and muscle strength in women with pregnancy-related PPGP.

METHODS

This study will be a single-center, 3-armed, participant-blinded, randomized controlled trial. In total, 84 women diagnosed with pregnancy-related PPGP will be recruited and randomly assigned into 3 groups. Intervention groups A and B will receive pelvic and lumbar supports, respectively. Group C (control) will receive only a patient education leaflet containing advice on strengthening exercises, comfortable positions, and other practical information. The study outcomes are pain, effort score during the active straight leg raising test, maximum isometric hip flexion force, maximum isometric hip external rotation force, maximum isometric trunk rotation force, and joint position reproduction of hip abduction. The study outcomes will be measured at 4 time points: baseline (T1), immediately after the intervention (T2), 4 weeks following interventions began (at this time, the intervention period is completed) (T3), and 1 week after discontinuing the interventions (T4) to evaluate the possible lasting effects of wearing supports. Multivariate analysis of variance will be used to test between- and within-group differences.

RESULTS

Recruitment for this study will be started in summer 2022 and is expected to be completed by the end of fall 2022.

CONCLUSIONS

This study will examine the efficacy of broader lumbar support as an early rehabilitative treatment for women receiving postpartum posterior pelvic pain support compared to those receiving a narrower pelvic support. We expect the broader lumbar support to impact pain management and disability better than the current narrower pelvic belt. Long-term follow-up studies will help determine whether such lumbosacral orthosis reduces pain and improves daily activities in women with pregnancy-related PPGP.

TRIAL REGISTRATION

Iranian Registry of Clinical Trials IRCT20150210021034N11; https://www.irct.ir/trial/54808.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40553.

摘要

背景

妊娠相关的骨盆后环疼痛(PPGP)是产后背痛最重要的临床表现之一。患者常抱怨日常活动时感到不适。据推测,运动控制改变与疼痛感知有关。骨盆支撑可调节可能存在的潜在运动控制机制改变并减轻疼痛。然而,腰骶矫形器作为一种更广泛的支撑,能提供更宽的接触面积和更多的皮肤感觉刺激以恢复正常运动功能,其对产后PPGP女性的影响尚未得到研究。

目的

本研究探讨更宽的腰部支撑和更窄的骨盆支撑对妊娠相关PPGP女性的疼痛、本体感觉、功能障碍和肌肉力量的影响。

方法

本研究将是一项单中心、三臂、参与者盲法、随机对照试验。总共将招募84名被诊断为妊娠相关PPGP的女性,并随机分为3组。干预组A和B将分别接受骨盆和腰部支撑。C组(对照组)将仅收到一份包含加强锻炼建议、舒适姿势及其他实用信息的患者教育手册。研究结局包括疼痛、主动直腿抬高试验中的用力评分、最大等长髋屈曲力、最大等长髋外旋力、最大等长躯干旋转力以及髋关节外展的关节位置重现。研究结局将在4个时间点进行测量:基线(T1)、干预后立即(T2)、干预开始后4周(此时干预期结束)(T3)以及停止干预1周后(T4),以评估佩戴支撑物可能产生的持久效果。将使用多因素方差分析来检验组间和组内差异。

结果

本研究将于2022年夏季开始招募,预计2022年秋季末完成。

结论

本研究将检验与接受更窄骨盆支撑的女性相比,更宽的腰部支撑作为产后骨盆后疼痛女性早期康复治疗的效果。我们预计更宽的腰部支撑在疼痛管理和功能障碍改善方面比目前更窄的骨盆带效果更好。长期随访研究将有助于确定这种腰骶矫形器是否能减轻妊娠相关PPGP女性的疼痛并改善其日常活动。

试验注册

伊朗临床试验注册中心IRCT20150210021034N11;https://www.irct.ir/trial/54808。

国际注册报告识别码(IRRID):PRR1-10.2196/40553。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/094c/9350821/7e6b61f2d92c/resprot_v11i7e40553_fig1.jpg

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