早期膝骨关节炎的六步手法治疗及步态分析研究
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摘要
1.研究背景
膝骨关节炎是临床上中老年患者的常见病和多发病,临床表现以膝关节疼痛和功能受限为主,严重影响生活质量。流行病学资料显示,随着人口老龄化的加剧,膝OA的发病率日趋升高。为此,世界卫生组织将2000-2010年的全球健康主题确定为“骨与关节10年”,在全球范围内唤起人们对骨关节疾患的广泛关注。膝关节是主要负重关节,一旦患病容易持续加重,治疗的目的是缓解疼痛,阻止和延缓疾病的进展,保护关节功能,改善生活质量。膝骨关节炎的治疗指南中一般推荐金字塔治疗,早期以预防为主,包括健康宣教和适当的运动锻炼,结合各种物理治疗；中期药物治疗为主,包括缓解症状的药物和骨关节炎慢作用药及软骨保护剂；后期则以外科治疗为主,主要包括关节镜治疗和人工关节置换术。毋庸置疑,现代关节外科学的发展使人工关节置换术取得了长足的进步,术后功能恢复明显,并发症减少,使得很多重度膝OA患者重新恢复生存能力。但从社会学和卫生经济学角度考虑,关节的外科治疗只能是最终的临床选择,有严格的适应症,既不适合于轻中度和年龄较小的患者,还对术者和手术条件有较高要求。药物治疗由于其副作用明显不宜长期应用。因而,早期预防与合理治疗极为重要,是临床上最有效最实际的减少膝关节功能损伤的措施。
得到循证医学支持的早期预防和治疗的措施包括自我管理、超重患者减轻体重、有氧低强度的适应性锻炼、股四头肌力量练习等。针灸的止痛作用也获得了一些系统性回顾研究证实,但临床上常用的手法治疗并没有被明确推荐使用,常常被当做一种辅助手段。分析其原因,主要有两点：第一、手法治疗在骨伤科疾病中是一种比较宽泛的概念,临床上常以操作特点分门别类,如点、按、揉、推、拿、捏、提等,流派众多,各有侧重。有针对性的治疗早期膝OA的手法相对较少,往往是伤科手法的综合运用,缺乏系统整理。早期膝OA手法治疗的随机对照研究很少,常见的单纯病例报道证据等级较低,不足以证实其临床疗效。第二目前存在的膝OA诊断标准,使人们过多的关注膝OA的骨性改变,而忽视了膝周软组织的病变对整个病程的影响。如果在出现明显的骨性改变时才进行手法治疗,疗效往往不能令人满意。另外的问题是,膝关节功能评定上缺乏客观指标,早期影像学改变不明显或与临床表现不符合时,单纯依靠主诉和体格检查能否严谨的反映膝关节功能?针对软组织为主的手法治疗又是否能改善膝关节的功能?这些问题均需要进行深入的研究。
步态分析作为生物力学的特殊分支,是对人体行走时的肢体和关节活动进行运动学观察和动力学分析,涉及下肢各关节和肌肉的协同运动。对于临床诊断、疾病程度测定、术后疗效评价、生物力学及康复研究具有重要意义,在下肢骨科疾病中应用广泛。目前,对早期膝OA的步态分析研究报道很少,用于评定膝关节手法治疗前后的步态特征,探讨膝关节功能改善程度的研究鲜有报道。导师在前期课题中对膝OA治疗前后的步态分析有过一些初步的探讨,发现膝骨关节炎患者步态特征与临床表现并不完全一致。本试验将利用Footscan测试系统进一步研究早期膝OA步态特征及六步手法治疗前后的步态变化。
“六步手法”是对中国中医科学院已故的四位中医骨伤科专家杜自明、刘道信、葛云彬、陈正光的伤科流派手法的继承和创新。老一辈专家的伤科学术思想及手法特征是中医伤科学中尤为宝贵的资源,临床应用于早期膝OA患者疗效显著,但是至今却尚未进行系统整理和科学的评价。随着时间流逝,现代外科技术的发展,膝关节的手法应用逐渐减少,特色手法近将失传。因此,尽早的进行系统化的整理和研究膝关节手法,既是对老一辈专家学术思想及手法特点的继承和创新,也是从科学论证的角度为膝OA的早期手法治疗提供证据支持。手法治疗的临床有效性和科学性是否能得到当前诊疗标准的检验,对循证医学的证据支持是否能脱离经验医学的窠臼,均需要一项严格设计的随机对照临床试验方案的实施来总结归纳,这也是本研究的根本出发点。
2.研究目的
利用Footscan系统分析早(中)期膝OA的步态特征,建立早(中)期膝OA步态数据库,作为诊断、治疗膝OA的生物力学参数。
结合既有的膝OA评价指标和现代步态分析技术,实施随机对照临床试验方案,评价六步手法的临床疗效,分析早期膝OA患者治疗前后膝关节功能状况,阐述其作用机理,进一步证实六步手法的临床实用性和科学性。
3.研究内容
3.1膝关节骨关节炎人群的步态分析
3.1.1材料与方法
研究对象来源于中国中医科学院望京医院门诊或住院患者,符合早期或中期膝关节骨关节炎诊断。利用比利时RSscan公司footscan plate system步态测试系统,按照规定测试方法获得纳入人群的步态资料,包括图像分析及步态数据。按照双膝OA患者及单膝OA患者分类,分别描述三个方面的参数足底压力曲线、双足支撑期时间及支撑期各阶段时间百分比、支撑期足底接触面积和冲量百分比、支撑期足底内外侧冲量百分比、支撑期前足五个分区冲量百分比、外展角和距下关节活动角、平衡曲线。
3.1.2结果
1)在步态周期中,双膝OA患者足底压力没有典型的双峰曲线,呈不规则的弓背向上的弧形或平弧形,受个体差异影响明显。
2)膝OA患者支撑期时间较正常人群延长,双膝OA患者左右侧无差异,单膝OA患者患侧短于健侧。支撑期各阶段时间比较显示膝OA患者前足着地阶段时间延长,全足支撑阶段及前足蹬离阶段时间减少。
3)足跟内侧冲量大于外侧；前足冲量变化不稳定,但中间跖骨头冲量增大；支撑阶段冲量前足最大,足弓最小,单膝OA患者足跟部冲量健侧大于患侧；接触面积与正常人群分布特征类似,
4)在膝OA患者支撑期,外展角和距下关节活动角均大于正常人。
3.1.3结论
通过Footscan测试系统能比较完整的收集膝OA患者的步态参数,通过这些数据的分析及与正常参考值的比较,阐述并分析膝OA患者的步态特征。
3.2早期膝骨关节炎六步手法治疗的临床研究
3.2.1材料与方法
研究对象来源于中国中医科学院望京医院门诊或住院患者,符合早期膝关节骨关节炎诊断。按照随机对照的设计方案,60例患者分为治疗组和对照组,每组30例,治疗组(47膝)采取六步手法治疗,对照组(50膝)予以电针治疗,两组在治疗期间及治疗后均配合股四头肌功能锻炼。治疗后4周及半年时分别进行疗效评定,包括VSA评分、JOA评分和有效率
3.2.2结果
1)两组患者基线比较：两组资料经统计学处理在性别、年龄、病程上差异无显著性意义(P>0.05),治疗前VAS评分和JOA评分也无统计学差异(P>0.05),具有可比性。
2)两组VAS评分：治疗后4周与治疗后半年,两组患者的VAS评分值均降低(P<0.001),治疗前和治疗半年后VAS评分差值比较,手法组的VAS差值大于电针组(P<0.05),结果具有显著性意义。
3)两组JOA评分：治疗后4周与治疗后半年,两组患者的JOA评分值在单项及总分均高于治疗前(P<0.001),与治疗后4周比较,半年复查时步行和上下楼梯的疼痛情况进一步缓解。半年时,手法组在上下楼梯时疼痛评分单项上优于电针组(P<0.01)。
4)两组有效率比较：4周时手法组总有效率为91.49%,电针组总有效率为86%；治疗后半年,手法组总有效率为93.62%,电针组优总有效率为92%。两组无明显差异(P>0.05)
3.2.3结论
六步手法和电针治疗均能有效缓解早期膝OA的症状,临床有效率无明显差异。但通过随访观察,比较后期疗效,手法治疗对于改善患者髌股关节功能效果明显,缓解上下楼梯时的疼痛优于电针组,对于调整膝关节的内外侧软组织结构,恢复膝关节在行走活动中动态平衡,手法治疗要优于电针。
3.3早期膝骨关节炎六步手法治疗的步态分析研究
3.3.1材料与方法
研究对象来源于中国中医科学院望京医院门诊或住院患者,符合早期膝关节骨关节炎诊断。按要求接受六步手法和电针治疗,治疗前及治疗后半年进行步态分析比较。最终纳入研究进行步态分析的患者手法组有13例,电针组有16例,均为双膝OA,且治疗前左右膝症状及体征评分无明显差异。步态分析的参数包括时间参数、冲量参数和平衡参数。
3.3.2结果
1)时间参数：两组治疗后双侧行走时支撑期时间均小于疗前(P<0.01或P<0.05)。两组支撑期各阶段时间百分比在治疗前与治疗后,均表现为前足着地阶段时间延长,全足支撑阶段和前足蹬离阶段时间缩短,治疗后与治疗前同侧同阶段比较,时间百分比无明显改变(P>0.05)。
2)冲量参数：六步手法治疗后,双侧足跟冲量比增大(P<0.05),前足冲量比减小(P<0.05),足跟与前足的冲量比例缩小。电针治疗后,双侧足跟冲量比增大(P<0.05),前足冲量比减下,左侧差异不显著(P=0.447),右侧有显著性差异(P=0.001),足跟与前足的冲量比例增大。两组疗法足弓冲量比无明显变化(P>0.05)。
3)平衡参数：六步手法治疗后,左右两侧外展角仍大于正常参考范围,但较治疗前减小(P<0.05)。电针治疗后,双侧外展角与治疗前外展角变化不明显(P>0.05),仍大于正常参考范围。
3.3.3结论
步态分析的结局与传统疗效评价不完全一致。冲量参数能够反映膝关节的缓冲能力,平衡参数能够反映膝关节内外侧软组织的稳定性,这几项参数均显示六步手法治疗后膝关节功能明显改善,可以更加客观、科学的阐述临床结局。六步手法的临床研究对于系统整理我院骨伤专家伤科学术思想和手法特征有积极意义。
4.总结
1)通过Footscan系统测试行走时的足底压力、支撑期时间、各阶段时间分布、冲量和触地面积比例、外展角和距下关节活动角,基本上能够反映膝OA患者膝关节功能和步态特征。
2)六步手法治疗早期膝OA在缓解疼痛和改善膝关节功能上有较好的临床疗效。
3)步态分析的结果比较客观的证实了六步手法治疗早期膝OA的临床有效性,加强和提高了对六步手法治疗早期膝OA机理的认识,验证了其科学内涵。
筋骨并重不仅是中西医结合治疗骨折的重要原则,同样也应该是伤科学中手法治疗早期膝OA的指导原则。研究中发现,早期膝骨关节炎具备两个重要特征：①软组织平衡改变早于骨性改变；②髌股关节软骨改变早手胫股关节。针对这两个特征,六步手法治疗过程中,遵从“筋束骨”和“骨正筋柔”的理念,调整关节周围软组织的平衡,恢复髌骨的正常解剖位置和运动轨迹。这一指导原则是六步手法治疗早期膝OA临床疗效的保证。
5.创新点
1)六步手法是在结合现代医学对早期膝OA病理和生物力学认识的基础上整理形成的,是对老一辈专家伤科学术思想和手法特征的继承和创新。
2)运用现代Footscan系统测试膝OA患者的步态,包括支撑期时间、支撑期各阶段比例、足底各区冲量和接触面积、外展角和距下关节活动角,建立膝OA患者步态数据库。
3)疗效评价上,应用支撑期时间、足底冲量变化、外展角等步态参数,从客观层面上证实了六步手法治疗早期膝OA的临床疗效。
1. Background
Knee osteoarthritis (KOA) is a common and frequently-occurring diseases in the aged people whose life quality is greatly degraded because of pain and functional limitations. Epidemiological data show that with the aging of the population intensifies, the incidence of KOA disease is increasing gradually. Therefore, 2000-2010 global health topics were identified as "Bone and Joint 10 years"by the World Health Organization, to arouse people to extensive concern of the osteoarthritis disease. The knee is the main weight-bearing joints, so the objective of treatment is to alleviate pain, prevent and delay the progress of the disease, protect the joint function, improve the quality of life. According to treatment guidelines for KOA, put prevention first to Early osteoarthritis, Including health education and functional training, a variety of physical therapy. And in osteoarthritis mid-term, drug therapy is given priority to, including DMARDs and NSAIDs. In the late osteoarthritis, surgical treatment is given priority to, mainly including arthroscopic treatment and total knee replacement. Undoubtedly, the development of the modern joint surgery artificial joint replacement has made good progress, postoperative function recovered significantly, complications reduce,it makes a lot of severe knee OA patients regain viability. But considering the sociology and health economics, the joint surgery can only be the final clinical choice because of the strict indication. Only apply to severe osteoarthritis and elderly patients and have higher requirements on the surgeon and surgical conditions. Drug shoulds not be long application because of side effects. Therefore, the early prevention and reasonable treatment is very important, it's the most effective and most practical clinical measures to reduce knee injured function.
There are some treatments got the support of evidence-based medicine, for example, self-management, overweight patients lose weight, low intensity aerobic exercise, quadriceps muscle strength training. Acupuncture analgesic effect also won some systematic reviews confirmed, but manual therapy is not explicitly recommend in clinical use, only be as a kind of auxiliary treatment. There are two reasons:first, In diseases of orthopedics manipulation treatment is now a relatively broad concept, and be divided into several classes according to different methods. The special manual therapy for KOA is relatively rare,instead of the comprehensive use of various treatments. Lack of systematic research and randomized controlled trial, simple case study can't explain the curative effect for low level of evidence. Second, because of the current diagnosis standard, people attach more importance to the bone structure than soft tissue. And the efficacy often cannot satisfactory, if osseous change significantly. In addition, if it is lack of objective indicators in knee function evaluation, and early x-ray is not obviously or not and clinical manifestations don't match with the clinical manifestations, should it be reflect the knee function only depend on physical examination and complaints? Can the manipulation treatment mainly for the soft tissue improve the function of the knee joint? These questions need to be further investigated.
As the biomechanics of special branch, gait analysis is to observe kinematic joint activities and analyse dynamics walking, which involved the cooperative movement of lower extremity joints and muscle. There is important significance in clinical diagnosis, disease extent determine effect assessment, and postoperative rehabilitation research biomechanics,and widly used in lower limb orthopaedic disease.At present, the gait analysis reports rarely about early KOA.There is almost no reports about gait characteristics of KOA after manual therapy. This paper discusses the function of gait characteristics of knee joint. On the subject of mentor in the knees OA before and after treatment, we found the the knees OA gait performance is not entirely consistent clinical features. This test will have a further research of early knee OA gait features depend on the Footscan test system and analysis of the gait changes before and after six-step manual therapy.
The six-step manual therapy is an instance of inheriting and innovating to Chinese manipulation of Du Ziming, Liu Daoxin. Ge Yunbin, Chen Zhengguang,who worked in China Academy of Chinese Medical Sciences(CACMS). The academic thoughts and technique characteristics of orthopedics and traumatology of TCM is particularly valuable resource. and is effectual of clinical application in early knee OA patients. But so far it hasn't been systematic arrangement and scientific evaluation. As time passed, modern surgical technology development, the clinical application of manual therapy is gradually diminishing, and even disappear. It is necessary to systematic research the manual therapy of Knee OA, not only for inheriting and innovating to Chinese manipulation, but also to provide scientific evidence to support clinical efficacy of manipulation. The effectiveness and science of manual therapy need to be confirmed by a strict designed clinical research. This is also the fundamental starting point of this study.
2. Objective
In order to establish gait database of early KOA, as biomechanical parameters of for KOA diagnosis, treatment, analysis gait characteristic by Footscan system for early (middle) KOA. Combined with gait analysis evaluation before and modern technology, and set randomized controlled clinical program to evaluate the clinical efficacy of six-step manual, analysis knee functional status pre- and post-treatment to explain its mechanism, furthermore confirmed its clinical utility and scientific.
3. Content
3.1 gait analysis of KOA patients
3.1.1 Materials and methods
The study objects are the patients who diagnosised early KOA,which come from the outpatient or inpatient in Wang Jing Hospital of Traditional Chinese Academy of Sciences. The gait test system was footscan by RSscan Company of Belgium,and obtain gait into the test group in accordance with the provisions of the test method, including image analysis and gait data. To classified in accordance with OA patients who were two knees or one knee disease, respectively, the parameters describe plantar pressure curve in three way, the stance phase and the percentage of time in various stages of stance phase, foot contact area in stance phase and the percentage of strike power, the percentage of strike power for inside and outside in stance phase, the percentage of strike power with five districts of forefoot, the abduction angle and Subtalar joint angle, foot balance curve.
3.1.2 Results
1) In the gait cycle, the plantar pressure was the typical bimodal curve in patients with OA knees, that was irregular upward curved or flat arc, significantly affected by individual differences.
2) Time of stance phase in KOA patients was more extension than the normal person, has no difference between left and right side in KOA patients with both knees, affected side is shorter than the healthy side in KOA patients who just one knee OA. To comparison of the time of various stages on stance phase of KOA, the time of Forefoot contact phase was prolonged, however Foot flat phase and the time of forefeet push off phase is reduced.
3) Impulse of heel medial was greater than the heel lateral;And it's instability in the forefoot, with the middle metatarsals increased; Impulse of forefoot at stance phase is maximum, and Midfoot least,. Heel impulse in the healthy side is greater than affected one of single KOA patient, contacts area similar to the normal.
4) In stance phase, the abduction angle and subtalar joints angle were larger than normal.
3.1.3 Conculsion
To completely collected the gait parameters by systemic Footscan test in KOA patients, it can reflect the characteristics of gait of KOA patients through the analysis these data and compared with normal reference values.
3.2 The clinical research in six-step manual therapy of early knee OA
3.2.1 Materials and methods
The study objects are the patients who diagnosised early KOA,which come from the outpatient or inpatient in Wang Jing Hospital of Traditional Chinese Academy of Sciences. In accordance with the randomized controlled and blinded design,60 patients were divided into half patients for treatment group and control group, the treatment group (47 knees) with six-step manual to treatment, the control group (50 knees) to treat by electric acupuncture. To functional exercise with the quadriceps in the two groups during and after treatment. Futhermore study after treatment for 4 weeks and six months, including efficacy evaluation, the VSA scores, JOA scores, and efficient.
3.2.2 Results
1) Comparison of the baseline in two groups:these of data was not significant change by statistical analysis of sex, age, disease duration (P>0.05), and state what we found pre-treatment VAS score and JOA score also was no significant difference in statistics (P>0.05).
2) Comparison of VAS scores:VAS score of both groups of patients were decreased at 4 weeks and six months post-treatment (P<0.001), VAS score compared difference pretreatment with post-treatment after six months, the difference data of manual group is greater than the EA group (P<0.05)
3) Comparison of JOA scores:the single point and total scores of JOA score of two groups at the 4weeks of post-treatment were higher than scores of pretreatment. To review of gaint, pain walking up and down stairs, further ease at 4 weeks of post-treatment compared with six months.In addition, the single score of pain in the up and down stairs for massage group was better than the EA group at six months.
4) Comparison of efficient:total efficient of massage group was 91.49% at 4weeks of post-treatment,but that of EA group was 93.62%, then former was 93.62 at six months of post-treatment,and the latter was 92%.Consequently two groups has no statistically significant difference.(P>0.05)
3.2.3 Conclusion
To relieve symptoms of early KOA by both six-step manual and acupuncture treatment, there were no significant difference in clinical efficacy. But by follow-up observation, to comparison on later effects, manual therapy is better than EA group for these way:improved with function of patellofemoral, and ease the pain of up and down stairs,moreover adjusted the knee joint lateral soft tissue structures, and recover the knee in walking dynamic balance.
3.3 The gait analysis of six-step manual therapy of early knee osteoarthritis
3.3.1 Materials and methods
The study objects are the patients who diagnosised early KOA,which come from the outpatient or inpatient in Wang Jing Hospital of Traditional Chinese Academy of Sciences. These patients were treated by six-step manual and EA treatment,then analysis and compare the footscan with before treatment and after treatment in six months. Finally KOA patients who included in the study divided into two groups, and then had gait analysis, first group was 13 cases with manipulation, second was 16 patients with EA. In addition, symptoms and signs scores showed no significant difference with treatment before. Gait analysis parameters including time parameters, the Strike power parameters and balance parameters.
3.3.2 Results
1) Time parameters:The time of stance phase were shorter in two groups after treatment (P<0.01 or P<0.05).The percentage various stages at time of stance phase in before and after treatment for two groups, which appeared as the time of front feet touch the ground phase was prolonged, however time of full-foot hold phase and time of forefoot push off phase were shorter after treatment, but the same stage with same side, the percentage of time without significant change. (P>0.05)
2) Impulse parameters:Impulse of bilateral heel was increase after six-step manual treatment(P<0.05), and (P<0.05),. Impulse of bilateral heel was increase after EA treatment(P<0.05), and the ratio of strike power with forefoot was decreased,have not significant change in left side (P=0.447)but have more change in right(P=0.001), in addition the ratio heel and forefoot was decreased. Moreover the Impulse of foot arch had no more change in two groups(P>0.05).
3) Balance parameters:Abduction angle of both side was still greater than the normal range after six-step manual treatment, but lower than before treatment(P<0.05). Bilateral abduction angle did not change significantly after EA treatment, but higher than the normal reference range.
3.3.3 Conclusion
The finally data of evaluation in gait analysis was not fully consistent with the traditional effect. Strike power parameters can reflect the buffering capacity of the knee, and knee balancing parameters can reflect the stability of lateral soft tissue. To significantly improved knee joint function in these parameters after six-step manual treatment, and to explain of the clinical result by more objective and scientific way. Clinical study of six-step manual have positive meaning in inheriting and innovating to academic thought and manipulation of orthopedics and traumatology of TCM.
4. Summary
1) System examination can test plantar pressure, time of stance phase, time of each stage distribution, impulse and area ratio of touch ground, abduction angle and subtalar joints angle during walking by Footscan, It can reflect the function of knee joint and gait characteristics in KOA patients basically.
2) Six-step manual treatment have better clinical efficacy in the relieve pain and improved knee function for early KOA patients.
3) The results of gait analysis more objectively confirmed clinical effective after six-step manual treatment for early KOA, moreover strengthened and improved understanding in the mechanism of kOA through six-step manual treatment for early KOA, in addition confirmed scientificity for that.
"Jin as important as Bone''(筋骨并重)is not only the important principle of fracture healing treated by ITCWM,but also the guidelines of manual therapy of early knee osteoarthritis.There are two important features we found in the early knee osteoarthritis: (1) the soft tissues balance changes earlier than the osseous change; (2) patellofemoral joint cartilage change earlier than tibial strands of the joints. According to the two features, and based on the concept of "soft tissue bundle bone" (筋束骨)and "Normal bone decides well-functioning soft tissue"(骨正筋柔),the purpose of six-step manual therapy is to adjust the balance of articular soft tissue,restore patellar position and normal anatomic trajectory. The guiding principle is a six-step manipulation treatment early clinical curative effect of guarantee knees OA.The guiding principle is to ensure that the six-step manual therapy for early knee OA has good curative effect.
5. Innovation
1) Considering the biomechanical characteristics and pathological changes of knee OA, the six-step manual therapy is an instance of inheriting and innovating to academic thought and manipulation of orthopedics and traumatology of TCM.
2) To test and analyze gait parameters in KOA patients by Footscan systems, including the time of stance phase, the ratio of various stages in stance phase, strike power and area of plantar contact, the abduction angle and subtalar joints angle, established the gait database of knee OA patients.
3) The evaluation of clinical curative effect, Through the study on the time of stance phase, foot impulse change, abduction angle and others gait parameters, consequently evaluated the six-step manual treatment of early KOA, and confirmed the clinical efficacy from on the objective level.
膝骨关节炎是临床上中老年患者的常见病和多发病,临床表现以膝关节疼痛和功能受限为主,严重影响生活质量。流行病学资料显示,随着人口老龄化的加剧,膝OA的发病率日趋升高。为此,世界卫生组织将2000-2010年的全球健康主题确定为“骨与关节10年”,在全球范围内唤起人们对骨关节疾患的广泛关注。膝关节是主要负重关节,一旦患病容易持续加重,治疗的目的是缓解疼痛,阻止和延缓疾病的进展,保护关节功能,改善生活质量。膝骨关节炎的治疗指南中一般推荐金字塔治疗,早期以预防为主,包括健康宣教和适当的运动锻炼,结合各种物理治疗；中期药物治疗为主,包括缓解症状的药物和骨关节炎慢作用药及软骨保护剂；后期则以外科治疗为主,主要包括关节镜治疗和人工关节置换术。毋庸置疑,现代关节外科学的发展使人工关节置换术取得了长足的进步,术后功能恢复明显,并发症减少,使得很多重度膝OA患者重新恢复生存能力。但从社会学和卫生经济学角度考虑,关节的外科治疗只能是最终的临床选择,有严格的适应症,既不适合于轻中度和年龄较小的患者,还对术者和手术条件有较高要求。药物治疗由于其副作用明显不宜长期应用。因而,早期预防与合理治疗极为重要,是临床上最有效最实际的减少膝关节功能损伤的措施。
得到循证医学支持的早期预防和治疗的措施包括自我管理、超重患者减轻体重、有氧低强度的适应性锻炼、股四头肌力量练习等。针灸的止痛作用也获得了一些系统性回顾研究证实,但临床上常用的手法治疗并没有被明确推荐使用,常常被当做一种辅助手段。分析其原因,主要有两点：第一、手法治疗在骨伤科疾病中是一种比较宽泛的概念,临床上常以操作特点分门别类,如点、按、揉、推、拿、捏、提等,流派众多,各有侧重。有针对性的治疗早期膝OA的手法相对较少,往往是伤科手法的综合运用,缺乏系统整理。早期膝OA手法治疗的随机对照研究很少,常见的单纯病例报道证据等级较低,不足以证实其临床疗效。第二目前存在的膝OA诊断标准,使人们过多的关注膝OA的骨性改变,而忽视了膝周软组织的病变对整个病程的影响。如果在出现明显的骨性改变时才进行手法治疗,疗效往往不能令人满意。另外的问题是,膝关节功能评定上缺乏客观指标,早期影像学改变不明显或与临床表现不符合时,单纯依靠主诉和体格检查能否严谨的反映膝关节功能?针对软组织为主的手法治疗又是否能改善膝关节的功能?这些问题均需要进行深入的研究。
步态分析作为生物力学的特殊分支,是对人体行走时的肢体和关节活动进行运动学观察和动力学分析,涉及下肢各关节和肌肉的协同运动。对于临床诊断、疾病程度测定、术后疗效评价、生物力学及康复研究具有重要意义,在下肢骨科疾病中应用广泛。目前,对早期膝OA的步态分析研究报道很少,用于评定膝关节手法治疗前后的步态特征,探讨膝关节功能改善程度的研究鲜有报道。导师在前期课题中对膝OA治疗前后的步态分析有过一些初步的探讨,发现膝骨关节炎患者步态特征与临床表现并不完全一致。本试验将利用Footscan测试系统进一步研究早期膝OA步态特征及六步手法治疗前后的步态变化。
“六步手法”是对中国中医科学院已故的四位中医骨伤科专家杜自明、刘道信、葛云彬、陈正光的伤科流派手法的继承和创新。老一辈专家的伤科学术思想及手法特征是中医伤科学中尤为宝贵的资源,临床应用于早期膝OA患者疗效显著,但是至今却尚未进行系统整理和科学的评价。随着时间流逝,现代外科技术的发展,膝关节的手法应用逐渐减少,特色手法近将失传。因此,尽早的进行系统化的整理和研究膝关节手法,既是对老一辈专家学术思想及手法特点的继承和创新,也是从科学论证的角度为膝OA的早期手法治疗提供证据支持。手法治疗的临床有效性和科学性是否能得到当前诊疗标准的检验,对循证医学的证据支持是否能脱离经验医学的窠臼,均需要一项严格设计的随机对照临床试验方案的实施来总结归纳,这也是本研究的根本出发点。
2.研究目的
利用Footscan系统分析早(中)期膝OA的步态特征,建立早(中)期膝OA步态数据库,作为诊断、治疗膝OA的生物力学参数。
结合既有的膝OA评价指标和现代步态分析技术,实施随机对照临床试验方案,评价六步手法的临床疗效,分析早期膝OA患者治疗前后膝关节功能状况,阐述其作用机理,进一步证实六步手法的临床实用性和科学性。
3.研究内容
3.1膝关节骨关节炎人群的步态分析
3.1.1材料与方法
研究对象来源于中国中医科学院望京医院门诊或住院患者,符合早期或中期膝关节骨关节炎诊断。利用比利时RSscan公司footscan plate system步态测试系统,按照规定测试方法获得纳入人群的步态资料,包括图像分析及步态数据。按照双膝OA患者及单膝OA患者分类,分别描述三个方面的参数足底压力曲线、双足支撑期时间及支撑期各阶段时间百分比、支撑期足底接触面积和冲量百分比、支撑期足底内外侧冲量百分比、支撑期前足五个分区冲量百分比、外展角和距下关节活动角、平衡曲线。
3.1.2结果
1)在步态周期中,双膝OA患者足底压力没有典型的双峰曲线,呈不规则的弓背向上的弧形或平弧形,受个体差异影响明显。
2)膝OA患者支撑期时间较正常人群延长,双膝OA患者左右侧无差异,单膝OA患者患侧短于健侧。支撑期各阶段时间比较显示膝OA患者前足着地阶段时间延长,全足支撑阶段及前足蹬离阶段时间减少。
3)足跟内侧冲量大于外侧；前足冲量变化不稳定,但中间跖骨头冲量增大；支撑阶段冲量前足最大,足弓最小,单膝OA患者足跟部冲量健侧大于患侧；接触面积与正常人群分布特征类似,
4)在膝OA患者支撑期,外展角和距下关节活动角均大于正常人。
3.1.3结论
通过Footscan测试系统能比较完整的收集膝OA患者的步态参数,通过这些数据的分析及与正常参考值的比较,阐述并分析膝OA患者的步态特征。
3.2早期膝骨关节炎六步手法治疗的临床研究
3.2.1材料与方法
研究对象来源于中国中医科学院望京医院门诊或住院患者,符合早期膝关节骨关节炎诊断。按照随机对照的设计方案,60例患者分为治疗组和对照组,每组30例,治疗组(47膝)采取六步手法治疗,对照组(50膝)予以电针治疗,两组在治疗期间及治疗后均配合股四头肌功能锻炼。治疗后4周及半年时分别进行疗效评定,包括VSA评分、JOA评分和有效率
3.2.2结果
1)两组患者基线比较：两组资料经统计学处理在性别、年龄、病程上差异无显著性意义(P>0.05),治疗前VAS评分和JOA评分也无统计学差异(P>0.05),具有可比性。
2)两组VAS评分：治疗后4周与治疗后半年,两组患者的VAS评分值均降低(P<0.001),治疗前和治疗半年后VAS评分差值比较,手法组的VAS差值大于电针组(P<0.05),结果具有显著性意义。
3)两组JOA评分：治疗后4周与治疗后半年,两组患者的JOA评分值在单项及总分均高于治疗前(P<0.001),与治疗后4周比较,半年复查时步行和上下楼梯的疼痛情况进一步缓解。半年时,手法组在上下楼梯时疼痛评分单项上优于电针组(P<0.01)。
4)两组有效率比较：4周时手法组总有效率为91.49%,电针组总有效率为86%；治疗后半年,手法组总有效率为93.62%,电针组优总有效率为92%。两组无明显差异(P>0.05)
3.2.3结论
六步手法和电针治疗均能有效缓解早期膝OA的症状,临床有效率无明显差异。但通过随访观察,比较后期疗效,手法治疗对于改善患者髌股关节功能效果明显,缓解上下楼梯时的疼痛优于电针组,对于调整膝关节的内外侧软组织结构,恢复膝关节在行走活动中动态平衡,手法治疗要优于电针。
3.3早期膝骨关节炎六步手法治疗的步态分析研究
3.3.1材料与方法
研究对象来源于中国中医科学院望京医院门诊或住院患者,符合早期膝关节骨关节炎诊断。按要求接受六步手法和电针治疗,治疗前及治疗后半年进行步态分析比较。最终纳入研究进行步态分析的患者手法组有13例,电针组有16例,均为双膝OA,且治疗前左右膝症状及体征评分无明显差异。步态分析的参数包括时间参数、冲量参数和平衡参数。
3.3.2结果
1)时间参数：两组治疗后双侧行走时支撑期时间均小于疗前(P<0.01或P<0.05)。两组支撑期各阶段时间百分比在治疗前与治疗后,均表现为前足着地阶段时间延长,全足支撑阶段和前足蹬离阶段时间缩短,治疗后与治疗前同侧同阶段比较,时间百分比无明显改变(P>0.05)。
2)冲量参数：六步手法治疗后,双侧足跟冲量比增大(P<0.05),前足冲量比减小(P<0.05),足跟与前足的冲量比例缩小。电针治疗后,双侧足跟冲量比增大(P<0.05),前足冲量比减下,左侧差异不显著(P=0.447),右侧有显著性差异(P=0.001),足跟与前足的冲量比例增大。两组疗法足弓冲量比无明显变化(P>0.05)。
3)平衡参数：六步手法治疗后,左右两侧外展角仍大于正常参考范围,但较治疗前减小(P<0.05)。电针治疗后,双侧外展角与治疗前外展角变化不明显(P>0.05),仍大于正常参考范围。
3.3.3结论
步态分析的结局与传统疗效评价不完全一致。冲量参数能够反映膝关节的缓冲能力,平衡参数能够反映膝关节内外侧软组织的稳定性,这几项参数均显示六步手法治疗后膝关节功能明显改善,可以更加客观、科学的阐述临床结局。六步手法的临床研究对于系统整理我院骨伤专家伤科学术思想和手法特征有积极意义。
4.总结
1)通过Footscan系统测试行走时的足底压力、支撑期时间、各阶段时间分布、冲量和触地面积比例、外展角和距下关节活动角,基本上能够反映膝OA患者膝关节功能和步态特征。
2)六步手法治疗早期膝OA在缓解疼痛和改善膝关节功能上有较好的临床疗效。
3)步态分析的结果比较客观的证实了六步手法治疗早期膝OA的临床有效性,加强和提高了对六步手法治疗早期膝OA机理的认识,验证了其科学内涵。
筋骨并重不仅是中西医结合治疗骨折的重要原则,同样也应该是伤科学中手法治疗早期膝OA的指导原则。研究中发现,早期膝骨关节炎具备两个重要特征：①软组织平衡改变早于骨性改变；②髌股关节软骨改变早手胫股关节。针对这两个特征,六步手法治疗过程中,遵从“筋束骨”和“骨正筋柔”的理念,调整关节周围软组织的平衡,恢复髌骨的正常解剖位置和运动轨迹。这一指导原则是六步手法治疗早期膝OA临床疗效的保证。
5.创新点
1)六步手法是在结合现代医学对早期膝OA病理和生物力学认识的基础上整理形成的,是对老一辈专家伤科学术思想和手法特征的继承和创新。
2)运用现代Footscan系统测试膝OA患者的步态,包括支撑期时间、支撑期各阶段比例、足底各区冲量和接触面积、外展角和距下关节活动角,建立膝OA患者步态数据库。
3)疗效评价上,应用支撑期时间、足底冲量变化、外展角等步态参数,从客观层面上证实了六步手法治疗早期膝OA的临床疗效。
1. Background
Knee osteoarthritis (KOA) is a common and frequently-occurring diseases in the aged people whose life quality is greatly degraded because of pain and functional limitations. Epidemiological data show that with the aging of the population intensifies, the incidence of KOA disease is increasing gradually. Therefore, 2000-2010 global health topics were identified as "Bone and Joint 10 years"by the World Health Organization, to arouse people to extensive concern of the osteoarthritis disease. The knee is the main weight-bearing joints, so the objective of treatment is to alleviate pain, prevent and delay the progress of the disease, protect the joint function, improve the quality of life. According to treatment guidelines for KOA, put prevention first to Early osteoarthritis, Including health education and functional training, a variety of physical therapy. And in osteoarthritis mid-term, drug therapy is given priority to, including DMARDs and NSAIDs. In the late osteoarthritis, surgical treatment is given priority to, mainly including arthroscopic treatment and total knee replacement. Undoubtedly, the development of the modern joint surgery artificial joint replacement has made good progress, postoperative function recovered significantly, complications reduce,it makes a lot of severe knee OA patients regain viability. But considering the sociology and health economics, the joint surgery can only be the final clinical choice because of the strict indication. Only apply to severe osteoarthritis and elderly patients and have higher requirements on the surgeon and surgical conditions. Drug shoulds not be long application because of side effects. Therefore, the early prevention and reasonable treatment is very important, it's the most effective and most practical clinical measures to reduce knee injured function.
There are some treatments got the support of evidence-based medicine, for example, self-management, overweight patients lose weight, low intensity aerobic exercise, quadriceps muscle strength training. Acupuncture analgesic effect also won some systematic reviews confirmed, but manual therapy is not explicitly recommend in clinical use, only be as a kind of auxiliary treatment. There are two reasons:first, In diseases of orthopedics manipulation treatment is now a relatively broad concept, and be divided into several classes according to different methods. The special manual therapy for KOA is relatively rare,instead of the comprehensive use of various treatments. Lack of systematic research and randomized controlled trial, simple case study can't explain the curative effect for low level of evidence. Second, because of the current diagnosis standard, people attach more importance to the bone structure than soft tissue. And the efficacy often cannot satisfactory, if osseous change significantly. In addition, if it is lack of objective indicators in knee function evaluation, and early x-ray is not obviously or not and clinical manifestations don't match with the clinical manifestations, should it be reflect the knee function only depend on physical examination and complaints? Can the manipulation treatment mainly for the soft tissue improve the function of the knee joint? These questions need to be further investigated.
As the biomechanics of special branch, gait analysis is to observe kinematic joint activities and analyse dynamics walking, which involved the cooperative movement of lower extremity joints and muscle. There is important significance in clinical diagnosis, disease extent determine effect assessment, and postoperative rehabilitation research biomechanics,and widly used in lower limb orthopaedic disease.At present, the gait analysis reports rarely about early KOA.There is almost no reports about gait characteristics of KOA after manual therapy. This paper discusses the function of gait characteristics of knee joint. On the subject of mentor in the knees OA before and after treatment, we found the the knees OA gait performance is not entirely consistent clinical features. This test will have a further research of early knee OA gait features depend on the Footscan test system and analysis of the gait changes before and after six-step manual therapy.
The six-step manual therapy is an instance of inheriting and innovating to Chinese manipulation of Du Ziming, Liu Daoxin. Ge Yunbin, Chen Zhengguang,who worked in China Academy of Chinese Medical Sciences(CACMS). The academic thoughts and technique characteristics of orthopedics and traumatology of TCM is particularly valuable resource. and is effectual of clinical application in early knee OA patients. But so far it hasn't been systematic arrangement and scientific evaluation. As time passed, modern surgical technology development, the clinical application of manual therapy is gradually diminishing, and even disappear. It is necessary to systematic research the manual therapy of Knee OA, not only for inheriting and innovating to Chinese manipulation, but also to provide scientific evidence to support clinical efficacy of manipulation. The effectiveness and science of manual therapy need to be confirmed by a strict designed clinical research. This is also the fundamental starting point of this study.
2. Objective
In order to establish gait database of early KOA, as biomechanical parameters of for KOA diagnosis, treatment, analysis gait characteristic by Footscan system for early (middle) KOA. Combined with gait analysis evaluation before and modern technology, and set randomized controlled clinical program to evaluate the clinical efficacy of six-step manual, analysis knee functional status pre- and post-treatment to explain its mechanism, furthermore confirmed its clinical utility and scientific.
3. Content
3.1 gait analysis of KOA patients
3.1.1 Materials and methods
The study objects are the patients who diagnosised early KOA,which come from the outpatient or inpatient in Wang Jing Hospital of Traditional Chinese Academy of Sciences. The gait test system was footscan by RSscan Company of Belgium,and obtain gait into the test group in accordance with the provisions of the test method, including image analysis and gait data. To classified in accordance with OA patients who were two knees or one knee disease, respectively, the parameters describe plantar pressure curve in three way, the stance phase and the percentage of time in various stages of stance phase, foot contact area in stance phase and the percentage of strike power, the percentage of strike power for inside and outside in stance phase, the percentage of strike power with five districts of forefoot, the abduction angle and Subtalar joint angle, foot balance curve.
3.1.2 Results
1) In the gait cycle, the plantar pressure was the typical bimodal curve in patients with OA knees, that was irregular upward curved or flat arc, significantly affected by individual differences.
2) Time of stance phase in KOA patients was more extension than the normal person, has no difference between left and right side in KOA patients with both knees, affected side is shorter than the healthy side in KOA patients who just one knee OA. To comparison of the time of various stages on stance phase of KOA, the time of Forefoot contact phase was prolonged, however Foot flat phase and the time of forefeet push off phase is reduced.
3) Impulse of heel medial was greater than the heel lateral;And it's instability in the forefoot, with the middle metatarsals increased; Impulse of forefoot at stance phase is maximum, and Midfoot least,. Heel impulse in the healthy side is greater than affected one of single KOA patient, contacts area similar to the normal.
4) In stance phase, the abduction angle and subtalar joints angle were larger than normal.
3.1.3 Conculsion
To completely collected the gait parameters by systemic Footscan test in KOA patients, it can reflect the characteristics of gait of KOA patients through the analysis these data and compared with normal reference values.
3.2 The clinical research in six-step manual therapy of early knee OA
3.2.1 Materials and methods
The study objects are the patients who diagnosised early KOA,which come from the outpatient or inpatient in Wang Jing Hospital of Traditional Chinese Academy of Sciences. In accordance with the randomized controlled and blinded design,60 patients were divided into half patients for treatment group and control group, the treatment group (47 knees) with six-step manual to treatment, the control group (50 knees) to treat by electric acupuncture. To functional exercise with the quadriceps in the two groups during and after treatment. Futhermore study after treatment for 4 weeks and six months, including efficacy evaluation, the VSA scores, JOA scores, and efficient.
3.2.2 Results
1) Comparison of the baseline in two groups:these of data was not significant change by statistical analysis of sex, age, disease duration (P>0.05), and state what we found pre-treatment VAS score and JOA score also was no significant difference in statistics (P>0.05).
2) Comparison of VAS scores:VAS score of both groups of patients were decreased at 4 weeks and six months post-treatment (P<0.001), VAS score compared difference pretreatment with post-treatment after six months, the difference data of manual group is greater than the EA group (P<0.05)
3) Comparison of JOA scores:the single point and total scores of JOA score of two groups at the 4weeks of post-treatment were higher than scores of pretreatment. To review of gaint, pain walking up and down stairs, further ease at 4 weeks of post-treatment compared with six months.In addition, the single score of pain in the up and down stairs for massage group was better than the EA group at six months.
4) Comparison of efficient:total efficient of massage group was 91.49% at 4weeks of post-treatment,but that of EA group was 93.62%, then former was 93.62 at six months of post-treatment,and the latter was 92%.Consequently two groups has no statistically significant difference.(P>0.05)
3.2.3 Conclusion
To relieve symptoms of early KOA by both six-step manual and acupuncture treatment, there were no significant difference in clinical efficacy. But by follow-up observation, to comparison on later effects, manual therapy is better than EA group for these way:improved with function of patellofemoral, and ease the pain of up and down stairs,moreover adjusted the knee joint lateral soft tissue structures, and recover the knee in walking dynamic balance.
3.3 The gait analysis of six-step manual therapy of early knee osteoarthritis
3.3.1 Materials and methods
The study objects are the patients who diagnosised early KOA,which come from the outpatient or inpatient in Wang Jing Hospital of Traditional Chinese Academy of Sciences. These patients were treated by six-step manual and EA treatment,then analysis and compare the footscan with before treatment and after treatment in six months. Finally KOA patients who included in the study divided into two groups, and then had gait analysis, first group was 13 cases with manipulation, second was 16 patients with EA. In addition, symptoms and signs scores showed no significant difference with treatment before. Gait analysis parameters including time parameters, the Strike power parameters and balance parameters.
3.3.2 Results
1) Time parameters:The time of stance phase were shorter in two groups after treatment (P<0.01 or P<0.05).The percentage various stages at time of stance phase in before and after treatment for two groups, which appeared as the time of front feet touch the ground phase was prolonged, however time of full-foot hold phase and time of forefoot push off phase were shorter after treatment, but the same stage with same side, the percentage of time without significant change. (P>0.05)
2) Impulse parameters:Impulse of bilateral heel was increase after six-step manual treatment(P<0.05), and (P<0.05),. Impulse of bilateral heel was increase after EA treatment(P<0.05), and the ratio of strike power with forefoot was decreased,have not significant change in left side (P=0.447)but have more change in right(P=0.001), in addition the ratio heel and forefoot was decreased. Moreover the Impulse of foot arch had no more change in two groups(P>0.05).
3) Balance parameters:Abduction angle of both side was still greater than the normal range after six-step manual treatment, but lower than before treatment(P<0.05). Bilateral abduction angle did not change significantly after EA treatment, but higher than the normal reference range.
3.3.3 Conclusion
The finally data of evaluation in gait analysis was not fully consistent with the traditional effect. Strike power parameters can reflect the buffering capacity of the knee, and knee balancing parameters can reflect the stability of lateral soft tissue. To significantly improved knee joint function in these parameters after six-step manual treatment, and to explain of the clinical result by more objective and scientific way. Clinical study of six-step manual have positive meaning in inheriting and innovating to academic thought and manipulation of orthopedics and traumatology of TCM.
4. Summary
1) System examination can test plantar pressure, time of stance phase, time of each stage distribution, impulse and area ratio of touch ground, abduction angle and subtalar joints angle during walking by Footscan, It can reflect the function of knee joint and gait characteristics in KOA patients basically.
2) Six-step manual treatment have better clinical efficacy in the relieve pain and improved knee function for early KOA patients.
3) The results of gait analysis more objectively confirmed clinical effective after six-step manual treatment for early KOA, moreover strengthened and improved understanding in the mechanism of kOA through six-step manual treatment for early KOA, in addition confirmed scientificity for that.
"Jin as important as Bone''(筋骨并重)is not only the important principle of fracture healing treated by ITCWM,but also the guidelines of manual therapy of early knee osteoarthritis.There are two important features we found in the early knee osteoarthritis: (1) the soft tissues balance changes earlier than the osseous change; (2) patellofemoral joint cartilage change earlier than tibial strands of the joints. According to the two features, and based on the concept of "soft tissue bundle bone" (筋束骨)and "Normal bone decides well-functioning soft tissue"(骨正筋柔),the purpose of six-step manual therapy is to adjust the balance of articular soft tissue,restore patellar position and normal anatomic trajectory. The guiding principle is a six-step manipulation treatment early clinical curative effect of guarantee knees OA.The guiding principle is to ensure that the six-step manual therapy for early knee OA has good curative effect.
5. Innovation
1) Considering the biomechanical characteristics and pathological changes of knee OA, the six-step manual therapy is an instance of inheriting and innovating to academic thought and manipulation of orthopedics and traumatology of TCM.
2) To test and analyze gait parameters in KOA patients by Footscan systems, including the time of stance phase, the ratio of various stages in stance phase, strike power and area of plantar contact, the abduction angle and subtalar joints angle, established the gait database of knee OA patients.
3) The evaluation of clinical curative effect, Through the study on the time of stance phase, foot impulse change, abduction angle and others gait parameters, consequently evaluated the six-step manual treatment of early KOA, and confirmed the clinical efficacy from on the objective level.
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