| 1. BackgroundKnee 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. ObjectiveIn 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. Content3.1 gait analysis of KOA patients3.1.1 Materials and methodsThe 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 Results1) 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 ConculsionTo 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 OA3.2.1 Materials and methodsThe 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 Results1) 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 ConclusionTo 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 osteoarthritis3.3.1 Materials and methodsThe 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 Results1) 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 ConclusionThe 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. Summary1) 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. Innovation1) 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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