Adherence, tolerance and effectiveness of two different pelvic support belts as a treatment for pregnancy-related symphyseal pain - a pilot randomized trial.
Adherence, tolerance and effectiveness of two different pelvic support belts as a treatment for pregnancy-related symphyseal pain - a pilot randomized trial.
复制标题
DOI：
10.1186/s12884-015-0468-5
复制
发表时间：
2015-02-15
影响因子：
3.1
通讯作者：
Woodley SJ
中科院分区：
文献类型：
--
作者：
Flack NA;Hay-Smith EJ;Stringer MD;Gray AR;Woodley SJ
与妊娠相关的耻骨联合疼痛是相对常见的，并可显著干扰日常活动。物理治疗师规定的骨盆支撑带是一种治疗选择，但很少有证据支持其使用。该试验比较了两种骨盆带，以确定有效性（症状缓解）、耐受性（舒适性）和依从性（使用频率、持续时间）。非盲法、双臂、单中心、随机（1:1）平行组试验。从社区（新西兰达尼丁）招募了20名患有物理治疗师诊断的联合神经痛的孕妇，随机分配佩戴弹性或刚性腰带三周。一位未参与数据收集的作者将受试者随机分配到试验组。非盲法主要终点是患者特异性功能量表（PSFS）。次要结果为前24小时和前一周的疼痛强度（视觉模拟量表[VAS]）和残疾（改良Oswestry残疾问卷[MODQ]）。每天通过短信记录使用时间（小时）。参与者在基线、每周电话访谈和干预结束时（三周）进行评估。为了评估舒适度，女性在第四周穿了另一条腰带。20例孕妇（平均±SD年龄，29.4±6.5岁；基线平均妊娠期，30.8±5.2周）随机分为治疗组（弹性组=10，刚性组=10），均纳入分析。经基线调整后，随访时各组间PSFS评分无显著差异（平均差异- 0.1;95% CI: - 2.5至2.3;p =0.94）。前24小时疼痛对柔性带有利，差异有统计学意义（VAS, p = 0.049）。综合两组数据，功能和疼痛在三周时显著改善（平均差异为- 2.3;95% CI: 1.2至3.5;p< 0.001）。腰带平均每天佩戴4.9±2.9小时；女性更喜欢柔软的腰带。无不良事件报告。这些初步结果表明，灵活的骨盆支撑带在减轻疼痛方面可能更有效，并且可能比刚性带具有更好的耐受性。基于这些数据，一个更大的试验是可行的和临床有用的。澳大利亚新西兰临床试验注册中心（ANZCTR） ACTRN12614000898651, 2014年8月25日。本文的在线版本（doi:10.1186/s12884-015-0468-5）包含补充材料，可供授权用户使用。
Pregnancy-related pubic symphysis pain is relatively common and can significantly interfere with daily activities. Physiotherapist-prescribed pelvic support belts are a treatment option, but little evidence exists to support their use. This pilot compared two pelvic belts to determine effectiveness (symptomatic relief), tolerance (comfort) and adherence (frequency, duration of use). Unblinded, 2-arm, single-center, randomized (1:1) parallel-group trial. Twenty pregnant women recruited from the community (Dunedin, New Zealand), with physiotherapist-diagnosed symphyseal pain, were randomly allocated to wear either a flexible or rigid belt for three weeks. One author, not involved in data collection, randomized the allocation to trial group. The unblinded primary outcome was the Patient Specific Functional Scale (PSFS). Secondary outcomes were pain intensity during the preceding 24 hours and preceding week (visual analogue scale [VAS]), and disability (Modified Oswestry Disability Questionnaire [MODQ]). Duration of use (hours) was recorded daily by text messaging. Participants were assessed at baseline, by weekly phone interviews and at intervention completion (three weeks). To assess comfort, women wore the alternate belt in the fourth week. Twenty pregnant women (mean ± SD age, 29.4 ± 6.5 years; mean gestation at baseline, 30.8 ± 5.2 weeks) were randomized to treatment groups (flexible = 10, rigid =10) and all were included in analysis. When adjusted for baseline, PSFS scores were not significantly different between groups at follow up (mean difference −0.1; 95% CI: −2.5 to 2.3; p =0.94). Pain in the preceding 24 hours reached statistical significance in favor of the flexible belt (VAS, p = 0.049). Combining both groups’ data, function and pain were significantly improved at three weeks (mean difference −2.3; 95% CI: 1.2 to 3.5; p< 0.001). Belts were worn for an average of 4.9 ± 2.9 hours per day; women preferred the flexible belt. No adverse events were reported. These preliminary results suggest the flexible pelvic support belt may be more effective in reducing pain and is potentially better tolerated than a rigid belt. Based on these data, a larger trial is both feasible and clinically useful. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12614000898651, 25th August, 2014. The online version of this article (doi:10.1186/s12884-015-0468-5) contains supplementary material, which is available to authorized users.
登录
查看更多内容
影响因子：
2.8
作者：
Albert, H;Godskesen, M;Westergaard, J
通讯作者：
Westergaard, J
影响因子：
3.2
作者：
Fritz, JM;Irrgang, JJ
通讯作者：
Irrgang, JJ
影响因子：
105.7
作者：
Elden, H;Ladfors, L;Hagberg, H
通讯作者：
Hagberg, H
影响因子：
3
作者：
Mens, JMA;Vleeming, A;Snijders, CJ
通讯作者：
Snijders, CJ
DOI：
10.1111/j.1471-0528.2008.01904.x
发表时间：
2008-12-01
影响因子：
5.8
作者：
Elden, H.;Fagevik-Olsen, M.;Hagberg, H.
通讯作者：
Hagberg, H.