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振动疗法作为一种治疗股骨转子间骨折的干预措施——一项随机双盲、安慰剂对照试验。

Vibration therapy as an intervention for trochanteric hip fractures - A randomized double-blinded, placebo-controlled trial.

作者信息

Wong Ronald Man Yeung, Wong Pui Yan, Liu Chaoran, Chui Chun Sing, Liu Wing Hong, Tang Ning, Griffith James, Zhang Ning, Cheung Wing Hoi

机构信息

Department of Orthopaedics & Traumatology, The Chinese University of Hong Kong, Hong Kong SAR, China.

Department of Orthopaedics & Traumatology, Prince of Wales Hospital, Hospital Authority, Hong Kong SAR, China.

出版信息

J Orthop Translat. 2025 Jan 25;51:51-58. doi: 10.1016/j.jot.2025.01.002. eCollection 2025 Mar.

DOI:10.1016/j.jot.2025.01.002
PMID:39926341
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11802369/
Abstract

BACKGROUND

Hip fractures are one of the most serious forms of fragility fractures. Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation. The objectives of this study were to investigate the efficacy of LMHFV in trochanteric hip fracture elderly patients to (i) accelerate trochanteric fracture healing and (ii) improve clinical and functional outcomes.

METHODS

A randomized double-blinded, placebo-controlled clinical trial was conducted. Participants were randomly assigned into LMHFV or placebo intervention for 14 days. Primary outcome assessments were fracture healing assessed with CT scan and X-rays. Dual X-ray Absorptiometry (DXA) scan was performed to assess bone mineral density change. Secondary outcome assessments were clinical and functional outcomes with quadriceps muscle strength, balancing ability, handgrip strength, Time Up and Go (TUG) test, quality of life outcomes, pain, falls, and mortality.

RESULTS

237 patients were screened for eligibility by the inclusion and exclusion criteria. 62 patients were recruited and randomly assigned to placebo group (n = 32, mean age: 83.6 ± 7.0 years, women: 71.9 %) or LMHFV group (n = 30, mean age: 81.5 ± 5.7 years, women: 73.3 %). For fracture healing, CT scan at 6 weeks showed improved osseous union for the LMHFV group at 71.5 ± 19.4 % compared to placebo group at 58.8 ± 30.5 %, but no statistical significance detected. X-rays showed fractures healed at 12 months. LMHFV group had significantly higher quadriceps muscle strength compared to placebo group on affected leg using maximum reading (week 26: 8.8 ± 3.6 kg vs. 6.1 ± 4.1 kg; p = 0.011) and average reading (week 26: 8.0 ± 3.7 kg vs. 5.2 ± 3.3 kg; p = 0.008) amongst 3 trials. The balancing ability test could not be performed in most of the subjects at the baseline measurement. However, from week 6 to week 26, LMHFV group had significantly improved balancing compared to placebo group for overall stability index (week 26: 1.6 ± 1.1 vs. 3.4 ± 2.6; p = 0.006), anteroposterior stability index (week 26: 1.1 ± 0.7 vs. 2.1 ± 1.9; p = 0.048) and medial-lateral stability index (week 26: 0.9 ± 0.7 vs. 2.2 ± 2.2; p = 0.008). There was a significant increase in success in performing TUG test in LMHFV group from baseline (13.3 %) to 26 weeks (57.1 %) (p = 0.004). Quality-of-life outcomes by SF-36 showed LMHFV group had a significant improvement at a score of 62.1 ± 18.9 compared to control group at a score of 48.5 ± 18.9 after adjusting for the baseline measurement (p = 0.044).

CONCLUSION

A short duration of LMHFV during in-patient stay can improve clinical outcomes and can potentially be incorporated as a practical measure during the recovery of fragility hip fractures.

THE TRANSLATIONAL POTENTIAL OF THIS ARTICLE

14 days of LMHFV treatment is generally within the common in-patient stay period for hip fracture patients and therefore can potentially be incorporated into clinical practice with physiotherapy to facilitate recovery of hip fracture patients.

CLINICAL TRIAL REGISTRATION NUMBER

NCT04063891.

摘要

背景

髋部骨折是最严重的脆性骨折形式之一。低强度高频振动(LMHFV)是一种生物物理干预措施,可提供非侵入性的全身性机械刺激。本研究的目的是调查LMHFV对老年转子间髋部骨折患者的疗效,以(i)加速转子间骨折愈合,以及(ii)改善临床和功能结局。

方法

进行了一项随机双盲、安慰剂对照的临床试验。参与者被随机分为LMHFV组或安慰剂组,干预14天。主要结局评估是通过CT扫描和X线评估骨折愈合情况。进行双能X线吸收法(DXA)扫描以评估骨密度变化。次要结局评估是临床和功能结局,包括股四头肌力量、平衡能力、握力、起立行走测试(TUG)、生活质量结局、疼痛、跌倒和死亡率。

结果

通过纳入和排除标准筛选出237例符合条件的患者。招募了62例患者并随机分配至安慰剂组(n = 32,平均年龄:83.6 ± 7.0岁,女性:71.9%)或LMHFV组(n = 30,平均年龄:81.5 ± 5.7岁,女性:73.3%)。对于骨折愈合,6周时的CT扫描显示,LMHFV组的骨愈合改善率为71.5 ± 19.4%,而安慰剂组为58.8 ± 30.5%,但未检测到统计学意义。X线显示骨折在12个月时愈合。在三项试验中,LMHFV组患侧腿使用最大读数时的股四头肌力量显著高于安慰剂组(第26周:8.8 ± 3.6 kg对6.1 ± 4.1 kg;p = 0.011)和平均读数(第26周:8.0 ± 3.7 kg对5.2 ± 3.3 kg;p = 0.008)。在基线测量时,大多数受试者无法进行平衡能力测试。然而,从第6周到第26周,与安慰剂组相比,LMHFV组在整体稳定性指数(第26周:1.6 ± 1.1对3.4 ± 2.6;p = 0.006)、前后稳定性指数(第26周:1.1 ± 0.7对2.1 ± 1.9;p = 0.048)和内外侧稳定性指数(第26周:0.9 ± 0.7对2.2 ± 2.2;p = 0.008)方面的平衡能力有显著改善。LMHFV组进行TUG测试的成功率从基线时的13.3%显著提高到26周时的57.1%(p = 0.004)。SF-36生活质量结局显示,在调整基线测量后,LMHFV组得分为62.1 ± 18.9,显著高于对照组的48.5 ± 18.9(p = 0.044)。

结论

住院期间短期的LMHFV可改善临床结局,并有可能作为脆性髋部骨折恢复期间的一项实用措施。

本文的转化潜力

14天的LMHFV治疗通常在髋部骨折患者的常见住院期间内,因此有可能与物理治疗一起纳入临床实践,以促进髋部骨折患者的康复。

临床试验注册号

NCT04063891。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa8f/11802369/254c4ec2a860/gr4.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa8f/11802369/254c4ec2a860/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa8f/11802369/90929bbbd88a/ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa8f/11802369/bc121755584f/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa8f/11802369/9bc988ab28bf/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa8f/11802369/89bc80328efb/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa8f/11802369/254c4ec2a860/gr4.jpg

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