膝关节骨关节炎摆锤疗法:体内评估和随机单盲可行性临床试验

IF 5.9 1区 医学 Q1 ORTHOPEDICS Journal of Orthopaedic Translation Pub Date : 2024-03-01 DOI:10.1016/j.jot.2024.02.008
Lixia Huang , Zhidao Xia , Derick Wade , Jicai Liu , Guoyong Zhou , Chuanhua Yu , Helen Dawes , Patrick Esser , Shijun Wei , Jiuhong Song
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引用次数: 0

摘要

背景运动被推荐为膝关节骨性关节炎(KOA)的一线治疗方法;然而,很难确定哪些特定运动更有效。本研究旨在探究一种在中国被称为 "KOA摆动疗法"(KOAPT)的摆腿运动的潜在机制和有效性。关节内静水压和动态压力(IHDP)被认为可以部分解释 KOA 的症状和体征。因此,本文在进行可行性临床试验的同时,还打算在迷你猪和人类志愿者身上探索这一机制。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机械和循环环境的影响;2)测试进行大样本、随机/单盲临床试验是否可行。此外,还测量了腿部摆动对小猪滑膜血流量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。结果表明,小猪摆腿时膝关节内压发生动态变化,局部血流增加,滑液含量减少。健康人膝关节的关节内压为 -11.32 ± 0.21 (cmH2O),而 KOA 患者的关节内压为 -3.52 ± 0.34 (cmH2O)。在可行性临床试验中,所有组别均有 100% 的参与者完成了测量,两组的训练坚持率均为 95-98%。干预后,KOAPT 组和步行组的牛津膝关节评分均有明显下降(p < 0.01),但两组之间无明显差异。结论我们得出结论,KOAPT 有可能通过使膝关节机械压力正常化的机制来改善 KOA 的症状;但是,还需要对方法进行优化、进行长期干预以及进行最少 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更大的益处。研究人员利用迷你猪动物模型建立了膝关节骨性关节炎摆腿疗法的潜在机制,随后进行了随机、单盲可行性临床试验,并与常用的步行锻炼方案进行了比较。根据可行性试验的结果,建议在今后的研究中开展大样本临床试验,以开发出一种有效的 KOA 运动疗法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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

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 vivo 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 (cmH2O), whereas in KOA patients, it was −3.52 ± 0.34 (cmH2O). 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 (p < 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.

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来源期刊
Journal of Orthopaedic Translation
Journal of Orthopaedic Translation Medicine-Orthopedics and Sports Medicine
CiteScore
11.80
自引率
13.60%
发文量
91
审稿时长
29 days
期刊介绍: The Journal of Orthopaedic Translation (JOT) is the official peer-reviewed, open access journal of the Chinese Speaking Orthopaedic Society (CSOS) and the International Chinese Musculoskeletal Research Society (ICMRS). It is published quarterly, in January, April, July and October, by Elsevier.
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