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膝关节骨关节炎钟摆疗法:评估及一项随机、单盲可行性临床试验

Knee osteoarthritis pendulum therapy: evaluation and a randomised, single-blind feasibility clinical trial.

作者信息

Huang Lixia, Xia Zhidao, Wade Derick, Liu Jicai, Zhou Guoyong, Yu Chuanhua, Dawes Helen, Esser Patrick, Wei Shijun, Song Jiuhong

机构信息

Tianyuan Translational Medicine R&D Team, Medical School, Jianghan University, Wuhan, Hubei Province, China.

Institute of Life Science, Swansea University Medical School, Singleton Park, Swansea, SA2 8PP, UK.

出版信息

J Orthop Translat. 2024 Apr 8;45:266-276. doi: 10.1016/j.jot.2024.02.008. eCollection 2024 Mar.

Abstract

BACKGROUND

Exercise is recommended as the first-line management for knee osteoarthritis (KOA); however, it is difficult to determine which specific exercises are more effective. This study aimed to explore the potential mechanism and effectiveness of a leg-swinging exercise practiced in China, called 'KOA pendulum therapy' (KOAPT). Intraarticular hydrostatic and dynamic pressure (IHDP) are suggested to partially explain the signs and symptoms of KOA. As such this paper set out to explore this mechanism in minipigs and in human volunteers alongside a feasibility clinical trial. The objective of this study is 1) to analyze the effect of KOAPT on local mechanical and circulation environment of the knee in experimental animals and healthy volunteers; and 2) to test if it is feasible to run a large sample, randomized/single blind clinical trial.

METHODS

IHDP of the knee was measured in ten minipigs and ten volunteers (five healthy and five KOA patients). The effect of leg swinging on synovial blood flow and synovial fluid content depletion in minipigs were also measured. Fifty KOA patients were randomly divided into two groups for a feasibility clinical trial. One group performed KOAPT (targeting 1000 swings/leg/day), and the other performed walking exercise (targeting 4000 steps/day) for 12 weeks with 12 weeks of follow-up.

RESULTS

The results showed dynamic intra-articular pressure changes in the knee joint, increases in local blood flow, and depletion of synovial fluid contents during pendulum leg swinging in minipigs. The intra-articular pressure in healthy human knee joints was -11.32 ± 0.21 (cmHO), whereas in KOA patients, it was -3.52 ± 0.34 (cmHO). Measures were completed by 100% of participants in all groups with 95-98% adherence to training in both groups in the feasibility clinical trial. There were significant decreases in the Oxford knee score in both KOAPT and walking groups after intervention ( < 0.01), but no significant differences between the two groups.

CONCLUSION

We conclude that KOAPT exhibited potential as an intervention to improve symptoms of KOA possibly through a mechanism of normalising mechanical pressure in the knee; however, optimisation of the method, longer-term intervention and a large sample randomized-single blind clinical trial with a minimal 524 cases are needed to demonstrate whether there is any superior benefit over other exercises.

THE TRANSLATIONAL POTENTIAL OF THIS ARTICLE

The research aimed to investigate the effect of an ancient leg-swinging exercise on knee osteoarthritis. A minipig animal model was used to establish the potential mechanism underlying the exercise of knee osteoarthritis pendulum therapy, followed by a randomised, single-blind feasibility clinical trial in comparison with a commonly-practised walking exercise regimen. Based on the results of the feasibility trial, a large sample clinical trial is proposed for future research, in order to develop an effective exercise therapy for KOA.

摘要

背景

运动被推荐为膝关节骨关节炎(KOA)的一线治疗方法;然而,很难确定哪种具体运动更有效。本研究旨在探讨在中国进行的一种名为“KOA 摆锤疗法”(KOAPT)的腿部摆动运动的潜在机制和有效性。关节内静水压和动压(IHDP)被认为可以部分解释 KOA 的体征和症状。因此,本文着手在小型猪和人类志愿者中探索这种机制,并进行一项可行性临床试验。本研究的目的是:1)分析 KOAPT 对实验动物和健康志愿者膝关节局部力学和循环环境的影响;2)测试进行大样本、随机/单盲临床试验是否可行。

方法

在 10 只小型猪和 10 名志愿者(5 名健康者和 5 名 KOA 患者)中测量膝关节的 IHDP。还测量了腿部摆动对小型猪滑膜血流和滑膜液含量消耗的影响。50 名 KOA 患者被随机分为两组进行可行性临床试验。一组进行 KOAPT(目标为每条腿每天摆动 1000 次),另一组进行步行运动(目标为每天 4000 步),为期 12 周,并随访 12 周。

结果

结果显示,在小型猪摆动腿部时,膝关节内动压发生变化,局部血流增加,滑膜液含量减少。健康人膝关节的关节内压力为 -11.32 ± 0.21(cmH₂O),而 KOA 患者为 -3.52 ± 0.34(cmH₂O)。在可行性临床试验中,所有组的 100%参与者完成了测量,两组的训练依从性均为 95 - 98%。干预后,KOAPT 组和步行组的牛津膝关节评分均显著降低(P < 0.01),但两组之间无显著差异。

结论

我们得出结论,KOAPT 作为一种改善 KOA 症状的干预措施具有潜力,可能是通过使膝关节机械压力正常化的机制实现的;然而,需要对方法进行优化、进行长期干预以及开展至少 524 例的大样本随机 - 单盲临床试验,以证明其是否比其他运动有任何更优越的益处。

本文的转化潜力

该研究旨在调查一种古老的腿部摆动运动对膝关节骨关节炎的影响。使用小型猪动物模型建立膝关节骨关节炎摆锤疗法运动的潜在机制,随后与常用的步行运动方案进行随机、单盲可行性临床试验。基于可行性试验的结果,建议未来开展大样本临床试验,以开发一种有效的 KOA 运动疗法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cb06/11015744/7e60ea067000/ga1.jpg

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