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绝经激素治疗、运动或两者联合治疗能否改善大转子疼痛综合征绝经后女性的疼痛和功能?一项 2×2 析因随机临床试验。

Does Menopausal Hormone Therapy, Exercise, or Both Improve Pain and Function in Postmenopausal Women With Greater Trochanteric Pain Syndrome? A 2 × 2 Factorial Randomized Clinical Trial.

机构信息

Department of Physiotherapy, Podiatry and Prosthetics and Orthotics, La Trobe University, Melbourne, Victoria, Australia.

Olympic Park Sports Medicine Centre, Victoria, Australia.

出版信息

Am J Sports Med. 2022 Feb;50(2):515-525. doi: 10.1177/03635465211061142. Epub 2021 Dec 13.

DOI:10.1177/03635465211061142
PMID:34898293
Abstract

BACKGROUND

Greater trochanteric pain syndrome (GTPS) is a debilitating chronic condition, most prevalent in postmenopausal women. A positive association between high estrogen levels and tendon health may exist, and postmenopausal women have reduced estrogen. Menopausal hormone therapy (MHT) may reduce the incidence of tendon abnormality, particularly when combined with exercise.

PURPOSE

To determine the effect of MHT and exercise on tendon pain and function in postmenopausal women with GTPS.

STUDY DESIGN

Randomized controlled clinical trial; Level of evidence, 1.

METHODS

Postmenopausal women (N = 132; n = 12, lost to follow-up) with GTPS were randomized into MHT and placebo transdermal cream groups combined with tendon-specific or sham exercise. All groups received education about avoiding gluteal tendon compression and load management throughout 12 weeks of intervention. The primary outcome was the Victorian Institute of Sport Assessment for gluteal tendinopathy (VISA-G), and secondary outcomes were measured at baseline and at 12 and 52 weeks. The Global Rating of Change was assessed at 12 and 52 weeks. A linear mixed-effects model was used to assess differences. Body mass index (BMI) was included as a covariate.

RESULTS

All participant groups improved over time (baseline vs 12 weeks, < .001; baseline vs 52 weeks, < .001). There was no difference among exercise groups measured by all outcomes (VISA-G: baseline, = .97, mean difference [MD] = 0.10; 12 weeks, = .49, MD = 2.15; 52 weeks, = .32, MD = -3.08). There was a significant interaction effect between cream and BMI; therefore, the population was stratified by BMI levels (<25, <30, ≥30). The MHT groups (with exercise and education) had significantly better VISA-G outcomes (baseline, = .04, MD = -11.20, 95% CI = -21.70 to -0.70; 12 weeks, < .001, MD = -20.72, 95% CI = -31.22 to -10.22; 52 weeks, = .002, MD = -16.71, 95% CI = -27.21 to -6.22) and secondary measure scores as compared with placebo at all time points when BMI was <25.

CONCLUSION

MHT or placebo combined with tendon-specific or sham exercise plus education reduced pain and increased function for this population. For women with a BMI <25, MHT with any exercise plus education was better than placebo. A targeted exercise or sham exercise strategy is effective when prescribed with education about avoiding gluteal tendon compression and load management.

REGISTRATION

ACTRN12614001157662 (Australian New Zealand Clinical Trials Registry).

摘要

背景

大转子疼痛综合征(GTPS)是一种使人虚弱的慢性疾病,在绝经后妇女中最为常见。雌激素水平与肌腱健康之间可能存在正相关,而绝经后妇女的雌激素水平降低。激素替代疗法(MHT)可能会降低肌腱异常的发生率,尤其是与运动结合使用时。

目的

确定 MHT 和运动对 GTPS 绝经后妇女肌腱疼痛和功能的影响。

研究设计

随机对照临床试验;证据水平,1 级。

方法

将 132 名(n=12 名失访)GTPS 绝经后妇女随机分为 MHT 和安慰剂经皮贴剂组,联合进行肌腱特异性或假运动。所有组在 12 周的干预期间均接受避免臀肌腱受压和负荷管理的教育。主要结局指标为维多利亚运动评估臀肌腱病(VISA-G),次要结局指标在基线和 12 周和 52 周时测量。在 12 周和 52 周时进行整体变化的全球评估。采用线性混合效应模型评估差异。体重指数(BMI)被纳入协变量。

结果

所有参与者组在随访期间均有所改善(基线 vs 12 周,<0.001;基线 vs 52 周,<0.001)。所有结局指标的运动组之间均无差异(VISA-G:基线,=0.97,平均差异[MD]=0.10;12 周,=0.49,MD=2.15;52 周,=0.32,MD=-3.08)。乳膏与 BMI 之间存在显著的交互效应;因此,根据 BMI 水平(<25、<30、≥30)对人群进行分层。MHT 组(运动和教育)的 VISA-G 结局明显更好(基线,=0.04,MD=-11.20,95%CI=-21.70 至-0.70;12 周,<0.001,MD=-20.72,95%CI=-31.22 至-10.22;52 周,=0.002,MD=-16.71,95%CI=-27.21 至-6.22),次要测量评分也明显优于安慰剂在 BMI<25 时的所有时间点。

结论

MHT 或安慰剂联合肌腱特异性或假运动加教育可减轻疼痛并改善功能。对于 BMI<25 的女性,MHT 联合任何运动加教育均优于安慰剂。当制定避免臀肌腱受压和负荷管理的教育计划时,有针对性的运动或假运动策略是有效的。

注册

ACTRN12614001157662(澳大利亚新西兰临床试验注册中心)。

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