一、 摘要（abstract）

Background: Foot orthoses are widely used in conservative treatment of painful

flexible flatfoot however research is limited to choose the best option in orthotic

treatment.

背景：足矫形器广泛用于保守治疗疼痛的灵活的扁平足但是研究仅限于选择矫形器的较佳选择治疗。

Aim: We aimed to compare the effects of computer-aided design/computer-aided

manufacturing (CAD-CAM) and conventional insole types in comparison with sham

insole, on pain and health related quality of life in patients with painful flexible flatfoot

目的：我们的目的是比较计算机辅助设计/计算机辅助制造的效果（CAD-CAM）和传统的鞋垫类型与假的相比，疼痛和健康相关的疼痛的灵活的扁平足患者的生活质量

Design: Randomized controlled trial.

设计：随机对照试验。

Setting: Outpatient rehabilitation clinic.

环境：门诊康复诊所。

Population: Sixty-seven people with painful flexible flatfoot, aged between 18 and 45

years, were assigned to CAD-CAM (n=22), conventional (n=22) or sham (n=23) groups.

人群：67名患有疼痛的灵活的扁平足，年龄在18至45岁之间的被分配到CAD-CAM（n = 22），常规（n = 22）或假（n = 23）。

Methods: In addition to insoles, a home-based exercise program was followed by all

participants for eight weeks. Foot pain intensity and quality of life were assessed at the

initial evaluation and at the end of two-month follow-up.

方法：除鞋垫外，所有参与者都遵循家庭锻炼计划，为期八周。初步评估和两个月的随访结束后评估足部疼痛强度和生活质量。

Results: Pain intensity (Mean±SD, mm on VAS) was significantly lower in CAD-CAM

(27.84±18.41) and conventional (27.05±16.82) insole groups than sham group (46.39±20.18) after two months (p<.05), but="" there="" was="" no="" difference="" between="" conventional="" and="" cad-cam="" p="">.05). All groups had significantly higher physical health scores at the second assessment (p<.05), but="" there="" was="" no="" intergroup="" difference="" p="">.05).

结果：CAD-CAM（27.84±18.41）和常规（27.05±16.82）组中的疼痛强度（平均值±SD，VAS上的mm）比假组（46.39±20.18）显着降低两个月后（p <.05），但传统和cad-cam之间没有差异（p> .05）。第二次评估时的健康评分所有组的体力都明显增高（p <.05），但没有组间差异性（p>0.05）。

Conclusion: CAD-CAM and conventionally designed insoles are both more effective

than having sham insole in alleviating pain in painful flexible flatfoot.

结论：CAD-CAM和传统设计的鞋垫比使用假鞋垫缓解疼痛反复的扁平足更有效。

Clinical Rehabilitation Impact: CAD-CAM and conventionally designed semicustom

insoles in conjunction with a home-based exercise program are both effective in

controlling pain compared with sham insole and exercise in painful flexible flatfoot.

Clinicians can prescribe both types of semicustom insoles as a part of conservative

treatment instead of each other.

临床康复影响：与假鞋垫相比，CAD-CAM和常规设计的半定制鞋垫与家庭锻炼计划相结合都能有效控制疼痛，并在疼痛的灵活的扁平足运动中进行运用。临床医生可以将这两种类型的半定制鞋垫作为保守治疗的一部分治疗而不是彼此。

Keywords: CAD-CAM - Flatfoot - Foot orthoses - Pain - Quality of life

关键词：CAD-CAM  - 扁平足 - 足矫形器 - 疼痛 - 生活质量

二、 介绍（Introduction）

Painful flexible flatfoot (PFFF) is a common orthopedic problem that may results indisability,and its prevalence can be up to 20 % in some populations.People with flexible flatfoot deformity more likely to develop tendinopathy of the tibialis posterior or Achilles, plantar fasciitis, medial tibial stress syndrome, patellofemoral pain syndrome or even lower back pain as a result of increased loading on soft tissues.

疼痛的灵活的扁平足（PFFF）是一种常见的整形外科问题，可能导致残疾，并且在某些人群中其患病率可高达20％。 具有扁平足畸形的人更容易发生胫骨后肌或跟腱，足底筋膜炎，内侧胫骨应力综合征，髌股关节疼痛综合征或甚至由于软组织负荷增加导致的腰痛。

Different types of insoles are frequently used as a part of conservative treatment in PFFF.Their types vary significantly but can be broadly classified as prefabricated, semicustom or custom-made. Prefabricated insoles are widely available and made of different materials like silicone or thermoplastic in different sizes usually based on length of foot. Custom-made insole production involves capturing an impression of the foot, which can be performed manually with plaster casting or foam impression or digitally with a 3D scanner.Another cost-effective method, which is called semicustom, is usually performed simply by taking some metric measurements of the foot or adapting a prefabricated insole to the patients feet with some modifications.Although capturing 3D shape of the foot provides a more accurate model for insole, Zifchock and Davisfound similar outcomes in terms of foot kinematics for custom and semicustom insoles. Different types of insoles are frequently prescribed but it is still not clear which one is better in alleviating symptoms. Whilst some studies have shown positive effects of custom-made insoles on pain and function in PFFF,there is no worldwide consensus on material and design used in production of insoles

不同类型的鞋垫经常被用作PFFF保守治疗的一部分。它们的类型差异很大，但可大致分为预制，半定制或定制。预制鞋垫广泛可用，并且由不同材料制成，例如硅树脂或热塑性塑料，其尺寸通常基于足部长度。定制的鞋垫生产涉及捕获足部的印象，可以使用石膏铸造或泡沫印模手动进行或使用3D扫描仪进行数字化。另一种经济有效的方法，称为半定制，通常只需采取一些度量标准即可完成。测量尽管采用脚部的3D形状为鞋垫提供更明确的模型，但Zifchock和Davisfound在自定义和半定制鞋垫的足部运动学方面也有类似的结果。不同类型的鞋垫经常被开出，但仍然不清楚哪一种鞋子可以更好地缓解症状。虽然一些研究表明定制鞋垫对PFFF疼痛和功能的积极影响，但鞋垫生产中使用的材料和设计尚未达成全球共识

Over the last decade, the computer-aided design/computer-aided manufacturing (CAD CAM) method, integrated with a pedobarograph or a scanner, has been commonly used in insole production, but there is no research whether it is more effective than the other methods. Our aim was to compare the effects of CAD-CAM and conventionally designed insoles and providing control condition of a flat sham insole on pain and health related quality of life in PFFF. Because of the well-known positive effects of stretching and strengthening exercises in PFFF, we decided to give a home based exercise program to all participants. There were two hypotheses; i) Given in conjunction with home based exercises; CAD-CAM or conventional insoles are more effective than sham insole in reducing pain and improving health related quality of life in PFFF ii) CAD-CAM insole would have better outcomes than conventional insole.

在过去的十年中，计算机辅助设计/计算机辅助制造（CAD CAM）方法与脚踏仪或扫描仪集成，已经普遍用于鞋垫生产，但没有研究它是否比其他更有效。我们的目的是比较CAD-CAM和传统设计的鞋垫的效果，并提供一个扁平假鞋垫的疼痛和健康相关的生活质量的控制条件。由于PFFF伸展和加强锻炼众所周知的积极效果，我们决定为所有参与者提供一个以家庭为基础的锻炼计划。有两个假设; i）与家庭练习一起使用; 在PFFF中，CAD-CAM或传统鞋垫在减少疼痛和改善健康相关生活质量方面比假鞋垫更有效ii）CAD-CAM鞋垫比传统鞋垫具有更好的效果。

三、 材料和方法（materials and methods）

Subjects（主体）

This study was conducted between January 2014 and January 2016. Patients who presented to an outpatient clinic with foot pain of at least one month’s duration due to flexible flatfoot deformity were assessed. The eligibility criteria included being aged between 18 and 45 years, a minimum of + 6 points on the Foot Posture Index,a minimum 5 degrees standing tibiocalcaneal angle (measured with goniometer),no treatment of the foot for at least six months, no leg length discrepancy of more than 1 cm, no history of lower extremity surgery and no disease that could affect lower extremity biomechanics. The research procedures were approved by the Clinical Research Ethics Committee of Hacettepe University at 08th of January in 2014, with GO 14/18-31 decision number and written informed consent was obtained from all participants. The trial was registered with NCT02706327 registration number to ClinicalTrials.gov

这项研究是在2014年1月至2016年1月期间进行的。评估了由于扁平足畸形而出现至少一个月足部疼痛的门诊诊所的患者。 资格标准包括年龄在18至45岁之间，足部姿势指数至少为+ 6点，较低5度站立的双胫骨角（用测角仪测量），至少6个月没有治疗足部，没有腿长度差异超过1厘米，没有下肢手术史，也没有可能影响下肢生物力学的疾病。研究程序于2014年1月8日由Hacettepe大学临床研究伦理委员会批准，GO 14 / 18-31决定编号和所有参与者的书面知情同意书。 该试验以NCT02706327注册号注册到ClinicalTrials.gov

Eligible participants were randomly assigned into three parallel groups using simple randomization procedures. A computer generated list of random numbers was used for allocation with 1:1:1 ratio and each number were placed into an opaque, unmarked envelope. All these procedures including enrollment of participants after envelope selection, were performed by an independent researcher. After each group reached at least 10 participants (conventional-15, CAD-CAM-13, sham-10), we did a preliminary analysis and new participants were stratified according to pain intensity (lower and higher 50 mm) to minimize intergroup baseline difference, because mean of

conventional group was going notably higher than othergroups. A new generated random numbers were used and participants have selected envelopes just after they rated foot pain intensity.

用简单的随机化程序将符合条件的参与者随机分配到三个平行组中。 计算机生成的随机数列表用于以1：1：1的比例进行分配，并且每个数字被放入不透明的，未标记的信封中。 所有这些程序，包括选择信封后参与者的登记，均由独立研究人员进行。 在每组达到至少10名参与者（常规-15，CAD-CAM-13，假10）后，我们进行了初步分析，并根据疼痛强度（较低和较高的50 mm）对新参与者进行分层，以较大限度地减少组间基线差异 因为意思是传统群体明显高于其他群体。 使用了新生成的随机数，参与者在评估足部疼痛强度后选择了信封。

Outcome Measures（测量工具）

Foot pain intensity was assessed using the 100 mm visual analog scale (VAS) as the primary outcome. It is a commonly used valid tool for patients with foot pain.Participants were asked to rate the maximum level of foot pain on VAS after they were informed that zero means no pain and 100 means unbearable pain they experienced in the last week. In addition, the Foot Function Index was used to measure pain intensity and to assess difficulties participating in different activities.The Short Form-36 was used for health related quality of life assessment. We analyzed the physical and mental health sections of it separately to assess the main effect. We also investigated the physical activity level of participants because foot pain is strongly associated with activity and changes in activity could mask our treatment effect. The International Physical Activity Questionnaire-Short Form was used to determine each individual’s activity level with the exception of specific foot exercises that we advised to do. All of these measurements were performed by the five years experienced physiotherapist, at the initial evaluation and again after two months of insole use. Participants were also queried about how many days a week they had used the insoles and were asked to rate their insole satisfaction using a visual analog scale.

使用100mm视觉模拟评分（VAS）作为主要结果评估足部疼痛强度。对于足部疼痛患者来说，这是一种常用的有效工具。参与者被要求评估VAS足部疼痛的较大水平，因为他们被告知零意味着没有疼痛，100意味着他们在上周遇到的难以忍受的疼痛。此外，足部功能指数用于测量疼痛强度并评估参与不同活动的困难。简表36用于健康相关的生活质量评估。我们分别分析了它的身体和心理健康部分，以评估其主要影响。我们还调查了参与者的身体活动水平，因为足部疼痛与活动密切相关，活动的变化可能掩盖了我们的治疗效果。国际身体活动问卷 - 简表用于确定每个人的活动水平，但我们建议做的特定足部运动除外。所有这些测量均由具有五年经验的物理治疗师在初始评估时进行，并且在使用两个月的鞋垫后再次进行。参与者还被询问他们每周使用鞋垫多少天，并被要求使用视觉模拟量表对他们的鞋垫满意度进行评分。

Insole Production（鞋垫生产）

All insoles (Figure 1) were made by same orthotist who had six years’ experience about insole production, in order to eliminate personal differences. For CAD-CAM insole design, participants walked on a five-meter platform equipped with a pedobarograph(Medilogic, platform basic, Germany). The most natural gait without any pause or distinct asymmetric stepping and with clear pedobarographic measurement was selected by the orthotist after three repetitions. Measurement was recorded on computer by the software and then we designed a corrective foot insole with the software using this foot pressure data. We added 8 to 12 mm of height to the medial longitudinal arch pad, 4 to 6 mm metatarsal pad and 60 medial heel wedge into the design for all participants,similarly to other previous studies in literature. Pads were located using the pedobarographic pressure data. Completed design of insole opened with software of the integrated computer numerical control machine (PedCad, Germany) for production; 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering (Figure 1).

所有鞋垫（图1）均由具有六年鞋垫生产经验的同一矫形师制作，以消除个人差异。对于CAD-CAM鞋垫设计，参与者走在一个五米平台上，配备了一个pedobarograph（Medilogic，平台基础，德国）。选择较自然的步态，没有任何暂停或明显的不对称步进和明确的足底测量三次重复之后由矫形师。通过软件在计算机上记录测量结果，然后我们使用该足部压力数据用软件设计矫正足垫。我们为内侧纵弓垫增加了8到12毫米的高度，为所有参与者增加了4到6毫米的跖骨垫和60个内侧足跟楔形，类似于以前的其他文献研究。使用足底压力数据定位垫。用集成计算机数控机床（德国PedCad）软件打开完成的鞋垫设计，用于生产; 35肖氏A硬度乙基乙酸乙烯酯用于主鞋垫，3mm，15肖氏A硬度乙基乙酸乙烯酯用于覆盖（图1）。

For the conventional insole, the plantar surfaces of each patient’s metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. We drew an insole design on paper according to all of these measurements. The medial two-thirds of the midfoot for medial longitudinal arch, the middle two-thirds of the forefoot for metatarsal pad, and two-thirds of the heel for medial heel wedge were used as the standard padding design. They were shaped with using a grinder by the same orthotist. The height of medial longitudinal arch pad was lessened laterally and anteroposteriorly beginning from the navicular line to fill the arch. Metatarsal pad was lessened in the posterior and mediolateral directions keeping the anterior side more prominent. Medial heel wedge was shaped as a 6°rearfoot post as usual. After rectification process of pads, they were located and glued on a 1-mm polypropylene sheet. The height and material features of the padding and covering were the same for both the conventional and CAD-CAM designs (Figure 1).

对于传统的鞋垫，每个患者的跖趾关节的足底表面都标有厚的宽标记，并要求参与者站在干净的纸上。然后绘制足部的边界，并且从足跟的前部到一跖趾关节标记内侧纵弓长度。我们根据所有这些在纸上画了一个鞋垫设计测量。中足三分之二用于内侧纵弓，前足三分之二用于跖骨垫，三分之二用于内侧足跟楔形用作标准衬垫设计。它们是由同一个矫形器使用研磨机塑造的。内侧纵弓垫的高度横向减小，并从舟线开始前后填充拱。跖骨垫在后侧和内侧方向减少，保持前侧更突出。内侧鞋跟楔形被塑造为6°像往常一样的后脚掌。在垫的整流过程之后，将它们定位并胶合在1mm的聚丙烯片上。填充物和覆盖物的高度和材料特征对于传统和CAD-CAM设计都是相同的（图1）。

The 3 mm, 15 Shore A hardness ethyl vinyl acetate that was used to cover the main insoles, was also used as a flat sham insole for the third group (Figure 1). The insoles were implemented in a pair of standard walking-type, lace up, sports shoes after removal of the main insoles from the shoes and the participants were asked to wear the insole-equipped shoes frequently, especially during active outdoor activities. The shoes were patients own and not completely standardized across subjects within this study. The appropriateness and fitting of shoes were assessed by the physiotherapist.

用于覆盖主要鞋垫的3 mm，15 肖氏 A硬度乙基乙酸乙烯酯也用作第三组的平底鞋垫（图1）。从鞋子上取下主鞋垫后，鞋垫采用一双标准的步行式系带运动鞋，并要求参加者经常穿着配有鞋垫的鞋子，特别是在户外活动期间。 在本研究中，这些鞋是患者自己的并且不是完全标准化的。 鞋子的适当性和贴合性由物理治疗师评估。

Home Based Exercise（家庭锻炼）

A home based written exercise program which contains gastrocnemius stretching, tibialis posterior and intrinsic muscles strengthening given to all participants as mostly advised for flatfooted people.The gastrocnemius was stretched in a standing position by bending forward toward a wall with one leg in front and holding the position for 20 seconds. Body weight was used as resistance for the tibialis posterior muscle strengthening with heel rise. Towel grasping with toes was used for intrinsic muscle strengthening. These three exercises were given to perform twice a day with 10 repetitions however no monitoring of  compliance was performed within this study.

一个家庭为基础的书面锻炼计划，包括腓肠肌伸展，胫骨后肌和内在肌肉强化给予所有参与者，主要是腓肠肌通过一条腿在前面朝墙前弯并且保持姿势20秒的墙壁而得到伸展。

。 体重用作胫骨后肌强化的阻力伴随着足跟抬高。 用脚趾抓毛巾用于内在肌肉强化。 这三个练习每天进行两次，每次10个，但是，在本研究中没有对依从性进行监测。

Statistical Analysis and Sample Size（统计分析和样本量）

Analyses were performed with the Statistical Package for Social Sciences Version 18.0

(IBM, New York, USA) at the p ≤ .05 significance level for all comparisons. Normality

of the distribution was investigated by skewness-kurtosis, histogram graphics, normality

tests and plots before the statistical tests were performed. Group comparisons were

tested with One-way analysis of variance when normality was achieved and Kruskal Wallis test when not. A post-hoc test was used with Bonferroni correction. Before and

after treatment comparisons were tested using a paired sample t test or a Wilcoxon test,

and effect sizes (Cohen’s d) were calculated for significant differences. An effect size

between 0.2 and 0.5 was interpreted as a small effect, an effect size from 0.5 to 0.8 was

interpreted as a medium effect, and an effect size greater than 0.8 was interpreted as a

large effect. Numeric results were reported as the mean and standard deviation

(X±SD) along with frequencies by sample size and percentage (n/%). With an average

expected value in the control group of 50 mm and a standard deviation of 20 mm on the

visual analog scale, to detect a minimum clinically significant difference of 20 mm,25

each group needed minimum 21 individuals to achieve 80 % power with 5 % type I

error level. An intention to treat analysis was performed for participants who did not

come to the second assessment without any reported reason by consuming their pre treatment results also as their post-treatment results.

使用Statistical Package for Social Sciences Version 18.0进行分析（IBM，纽约，美国）所有比较的p≤0.05显着性水平。常态通过偏斜 - 峰度，直方图图形，正态性来研究分布

在进行统计测试之前进行测试和绘图。小组比较是当达到正常性时用单因素方差分析进行测试，而Kruskal Wallis测试则不进行测试。 Bonferroni校正使用事后检验。之前和

治疗后比较采用配对样本t检验或Wilcoxon检验进行检验，计算了影响大小（Cohen's d）的显着差异。效果大小在0.2和0.5之间被解释为小的效果，效果大小从0.5到0.8

解释为中等效果，效果大小大于0.8被解释为效果很大.数值结果报告为平均值和标准差（X±SD）以及样本大小和百分比（n /％）的频率。平均而言对照组的预期值为50 mm，标准偏差为20 mm视觉模拟量表，检测较小临床显着性差异为20 mm，25每组较少需要21个人才能达到80％的功率，5％的I型错误级别。对没有参与的参与者进行了治疗分析的意图通过消耗他们的预处理结果也作为他们的治疗结果，在没有任何报告原因的情况下进行第二次评估。

四、 结果（Results）

Eligible participants were recruited between January 2014 and September 2015 and the trial was stopped with the last follow up ended in January 2016. An overview of the study is presented in Figure 2. Age, body mass index, foot posture index and calcaneal valgus angle values were similar for all groups (Table I). We found no significant differences in the frequency of insole use or activity levels between groups.

符合条件的参与者是在2014年1月至2015年9月期间招募的，并且试验在2016年1月结束的较后一次随访中停止。该研究的概述如图2所示。年龄，体重指数，足部姿势指数和跟骨外翻角度值所有组都相似（表I）。 我们发现各组之间的鞋垫使用频率或活动水平没有显着差异。

Additionally, there were no significant differences for gender and pain localization distribution between the groups. Foot pain was rated as 59.7% on medial longitudinal arch and 40.3% on other areas such as the metatarsal, heel and ankle (Table I).

此外，各组之间的性别和疼痛本地化分布没有显着差异。内侧纵弓的足部疼痛评分为59.7％，跖骨，足跟和踝部的其他部位评定为40.3％（表I）。

There were no between-group differences in terms of the initial assessment of pain intensity, Foot Function Index and health related quality of life (p>.05, Table II).

在疼痛强度，足部功能指数和健康相关生活质量的初始评估方面没有组间差异（p> .05，表II）。

All groups had lower pain intensity, better Foot Function Index and physical quality of life scores after two months (p<.001). Pain was significantly lower in CAD-CAM and conventional groups than sham group at second assessment (p<.01), but="" there="" was="" no="" difference="" between="" cad-cam="" and="" conventional="" p="">.016, Table II). Both CAD-CAM and conventional insoles had medium effect sizes while sham insole had small effect size on pain reduction (Table II). No significant difference was found for Foot Function Index and physical quality of life between three groups after two months (p>.05, Table 2). However, the effect sizes on these two outcomes were both small in CAD-CAM and conventional groups but better than sham group (Table II). There was no significant satisfaction difference between the CAD-CAM and conventional insole (p>.016). Deteriorating of foot pain, measured by using VAS, was defined as a potential adverse event of treatment and none of the participants were reported worsened pain.

所有组在两个月后疼痛强度较低，足部功能指数较好，生活质量评分较高（p <.001）。在第二次评估中，CAD-CAM和常规组的疼痛显着低于假手术组（p <.01），但cad-cam与常规组之间没有差异（p> .016，表II）。 CAD-CAM和传统鞋垫都具有中等效果尺寸，而假鞋垫在减轻疼痛方面具有小的效果尺寸（表II）。两个月后三组之间的足部功能指数和身体生活质量没有显着差异（p> .05，表2）。然而，这两种结果的影响大小都很小

CAD-CAM和常规组但优于假组（表II）。 CAD-CAM与传统鞋垫之间没有明显的满意度差异（p> .016）。通过使用VAS测量的足部疼痛的恶化被定义为治疗的潜在不良事件，并且没有参与者报告疼痛恶化。

五、 讨论（Discussion）

Using CAD-CAM or conventional insoles in conjunction with home based exercise were more successful than sham insole and exercise in reducing pain, however none of them improved health related quality of life in PFFF. This partly confirmed our first hypothesis. The CAD-CAM insole had no superiority in comparison to conventional insole in terms of alleviating pain and so the second hypothesis was rejected.

使用CAD-CAM或传统鞋垫与家庭锻炼相结合比假鞋垫和运动更能成功减轻疼痛，但它们没有一个改善了PFFF的健康相关生活质量。这部分证实了我们的一次假设。 CAD-CAM鞋垫与传统鞋垫在减轻疼痛方面相比没有优势，因此第二个假设被否绝。

Whilst there are other studies that have investigated the effect of foot orthoses on foot pain and function for differentconditions, this study is the first to compare different types of insoles for PFFF. Pfeffer et al investigated the effect of different prefabricated and custom-made insoles in conjunction with home based stretching exercises in patients with proximal plantar fasciitis. They obtained better results for prefabricated insoles and stretching in comparison to custom made after two months of use. On the other hand, in two other studies; Wrobel et al and Martin et al showed positive and similar clinical outcomes for custom and prefabricated insoles in the treatment of plantar fasciitis. Contrary to our flatfooted sample group, participants had a specific pathology not deformity in these three studies; however patients with same pathology may have different foot deformities and may respond in a different manner to orthotic treatment. Also Wrobel et al found no difference in Foot Function Index and SF-36 scores between custom, prefabricated and sham insoles after three months of treatment. They also gave a home based self-care program in addition to insoles for all participants as we did in our study. Similarly, we did not find a significant difference between groups in health related quality of life and Foot Function Index, all groups had better scores after two months but the calculated effect sizes were quite small. Positive changes of sham group in both studies may be the results of home based exercises orsham insole or both of them. The main problem of these studies is the unknown compliance of patients to the exercises. In addition, Wrobel et al also showed a greater improvement in spontaneous physical activity in custom group and suggested that traditional outcome measures might not be sensitive or specific enough to detect main effects of treatment. We did not investigate possible effects of insoles on spontaneous physical activity level, because in our opinion pain free life may be an important factor but could not be the only reason of increased physical activity.

虽然还有其他研究调查了针对不同病情的疼痛和功能足部矫形器的影响，这项研究是一次比较不同PFFF的鞋垫类型。 Pfeffer等人调查了预制和定制鞋垫与家庭拉伸相结合近端足底筋膜炎患者的运动的不同的效果。两个月的使用后，与定制相比，他们在预制鞋垫和拉伸获得了更好的结果。另一方面，在另外两项研究中; Wrobel等人和Martin等人表明定制和预制鞋垫治疗足底筋膜炎有积极和类似的临床结果。与我们的平足样本组相反，参与者有一个这三项研究中的特定病理学不是畸形;但患者相同的病理可能有不同的足部畸形，并可能以不同的方式反映在矫形治疗中。此外，Wrobel等发现三个月后定制，预制和假鞋垫之间的足部功能指数和SF-36评分没有差异。他们还为所有研究中所做的参与者提供了除了鞋垫之外的家庭自我护理计划。同样，我们在健康相关生活质量和足部功能指数的群体之间没有发现显着差异，所有群体都有两个月后得分更高但计算出的效果量非常小。两项研究中假组的积极变化可能是基于家庭的运动或假鞋垫或两者的结果。这些研究的主要问题是未知患者遵守练习。此外，Wrobel等人还表明，定制组的自发性体力活动有了更大的改善，并表明传统的结局指标可能不敏感或不足以检测治疗的主要影响。。我们没有调查鞋垫对自发性可能影响身体活动水平，因为在我们看来，无痛苦的生活可能是一个重要因素，但这不是增加体力活动的一原因。

Zammit and Payne found approximately 20 % improvement in foot pain and foot function in symptomatic flatfoot after four weeks follow-up with insole. Our foot function changes were based on a different outcome measure, however, the results were similar. Furthermore, they used different insole types (18 custom made, 4 prefabricated) for participants and did not provide detailed information about the insoles. Effect sizes of insoles were small in both studies; this could be the limited effect of insoles on activity and participation in PFFF.

Zammit和Payne在使用鞋垫四周后，发现有症状的平足足部疼痛和足部功能改善约20％。我们的足部功能变化基于不同的结果测量，但结果相似。此外，他们使用不同的鞋垫类型（18个定制，4个预制）参与者，并没有提供有关鞋垫的详细信息。效果大小两项研究中的鞋垫都很小;这可能是鞋垫对活动和参与PFFF的影响有限。

According to results of above mentioned studies, insoles have positive clinical outcomes for relief of foot pain but there are still some conflicting results whether it should be prefabricated, semicustom or custom made, probably because of different sample groups of the studies. In our study we did not investigate this issue indeed. Both of insoles had similar padding designs on 2D measures of foot, therefore they both seemas semicustom insole. But using plantar pressure record in design, certain measures of pads and accuracy of milling makes CAD-CAM different than the conventional method.Therefore, it was the study of comparison two different manufacturing techniques and results of our study should be discussed being aware of it.

根据上述研究结果，鞋垫对于缓解足部疼痛有积极的临床效果，但仍然存在一些相互矛盾的结果，无论是预制，半定制还是定制，可能是因为不同样本组的研究。在我们的研究中，我们确实没有调查这个问题。两种鞋垫在尺寸为2D的脚上都有类似的衬垫设计，因此它们都是半定制鞋垫。但是在设计中使用足底压力记录，垫的某些测量和铣削精度使CAD-CAM与传统方法不同。因此，研究比较两种不同的制造技术，我们的研究结果应该被认识到它。

An interesting result of this study was the significant improvement in sham group. Basic exercises were given to the sham group and also they used a flat insole with sports shoes. However, it is hard to say that the positive changes of sham group resulted fromthe exercises or flat insole. Because we could not monitor the compliance to home exercises and most of participants were aware it was not an insole that might support their feet; however the sham insole got pretty high satisfaction score. It is not surprising because McCormick et al38 found that flat sham insole, same of which we used in our

study, decreases peak plantar pressure under the heel. Shock absorbing feature of thesham insole might be the reason of decreased pain in some cases. It could also be a result of sports shoes worn more frequently than before. Prescribed insoles are usually worn with a pair of athletic shoes in most of studies but researchers usually concentrate on the effect of insoles not shoes. In a different study; Esterman and Pilotto researched the effect of a prefabricated insole in flat-footed air force recruits with lower extremity musculoskeletal pain and did not observe any significant change. This study required participants to use orthoses with their military boots but 50% of participants failed to use insoles. Their results may have been influenced by the type of shoes used. This means insoles do not affect alone but with the shoes in which they are inserted.

这项研究的一个有趣结果是假手术组的显着改善。基本假手术组也进行了练习，他们还使用了带运动的平底鞋垫鞋。然而，很难说假团体的积极变化是由于练习或平底鞋垫。因为我们无法监控到家的合规性练习和大多数参与者都知道它不是可能支持的鞋垫他们的脚;然而假的鞋垫得到了很高的满意度。这并不奇怪因为McCormick等人发现了平底假鞋垫，我们在其中使用过研究，降低足跟下的足底压力峰值。减震功能在某些情况下，假鞋垫可能是疼痛减轻的原因。它也可能是一个运动鞋的磨损效果比以前更频繁。通常是指定的鞋垫在大多数研究中都穿着运动鞋，但研究人员通常会集中注意力关于鞋垫的效果而不是鞋子。在另一项研究中; Esterman和Pilotto研究了预制鞋垫在下肢肌肉骨骼疼痛的平足空军新兵中的效果，并没有观察到任何显着的变化。这项研究需要参与者使用矫形器与他们的军靴，但50％的参与者未能使用鞋垫。他们的结果可能受到所用鞋子类型的影响。这个意味着鞋垫不会单独影响，而是与插入它们的鞋子有关。

Most of patients came for the second assessment while some of them did not. They did not answer our call but we did intention to treat analysis as recommended to do in randomized controlled trials and we think it is a strong part of the study. We do not know the actual reason of their leave but it might be having considerably less complaints than the other subjects.

大多数患者进行第二次评估，而其中一些患者没有。他们做到了没有接听我们的电话，但我们确实打算按照建议进行分析随机对照试验，我们认为它是该研究的重要组成部分。我们不知道他们离开的实际原因，但可能投诉比其他科目会少得多。

It is the first study that has compared a novel method to a conventional for insole production in PFFF. Different CAD-CAM systems with different types and costs are increasingly used for prosthetic and orthotic production but other conventional methods like we used in our study are still being used especially in developing countries. Our purpose was to investigate if there was an additional effect of this technology on treatment but that is not true to discuss the pros and cons of CAD-CAM insoles only in terms of treatment outcomes. Also it should be noted that CAD-CAM is an umbrella term of the methods used in manufacturing with the aid of computer, our research was only about a small part of it. As we did not have the 3D measures of foot we used similar pad heights in both insoles. Therefore this study has compared the manual and computer aided methods in terms of design and shaping (milling) processes indeed.Although we have found no clinical difference between two methods, CAD-CAM is more likely to be used in this area because of its faster, more accurate and simple design and manufacturing features. In future, cost analysis of CAD-CAM systems should be investigated by researchers. This could be helpful for companies to give a decision about their necessity in production.

在PFFF中，这是一项将新方法与传统鞋垫进行比较的研究。具有不同类型和成本的不同CAD-CAM系统越来越多地用于修复和矫正生产，但我们研究中使用的其他常规方法仍然在发展中国家使用。我们的目的是调查这项技术是否对治疗产生了额外的影响，但仅仅就治疗结果来讨论CAD-CAM鞋垫的利弊是不正确的。还应该指出的是，CAD-CAM是借助计算机在制造中使用的方法的总称，我们的研究是只有一小部分。由于我们没有脚的3D测量，我们在两个鞋垫中都使用了相似的垫高度。因此，本研究在设计和成型（铣削）过程方面确实比较了手动和计算机辅助方法。虽然我们发现两种方法之间没有临床差异，但CAD-CAM是更有可能在这个领域使用，因为它更快，更准确和简单的设计和制造功能。将来，CAD-CAM系统的成本分析应该是由研究人员调查。这可能有助于公司决定他们在生产中的必要性。

研究局限（study limitations）

There are some issues which could limit our findings. Participants of the study had no specific pathology but flexible flatfoot deformity, the effect of insoles may differ in different pathologies. Also we did not monitor the compliance to home based exercise program so we do not know whether all of them did exercises like we advised. The young average age of our study population could limit the generalizability of our resultsand also the

two-month follow-up interval was sufficient to see the benefit of insoles but may not be long enough to determine whether the benefit will last.

有些问题可能会限制我们的研究结果。该研究的参与者没有特定的病理学，但有灵活的扁平足畸形，鞋垫的影响可能在不同的病理学上有所不同。 此外，我们没有监测家庭锻炼计划的遵守情况，因此我们不知道他们是否都像我们建议的那样进行锻炼。 我们研究人群的年轻平均年龄可能会限制我们结果的普遍性而且两个月的随访间隔足以看到鞋垫的好处，但可能不足以确定好处是否会持久。

七、结论（conclusions）

CAD-CAM and conventionally designed insoles in conjunction with a home-based exercise program are both more effective in controlling pain compared with sham insole and exercise in flexible flatfoot. Clinicians can prescribe both types of semicustom insoles as a part of conservative treatment in PFFF, instead of each other.

与假鞋垫相比，CAD-CAM和传统设计的鞋垫结合家庭锻炼计划更有效地控制疼痛在灵活的扁平足中。临床医生可以将两种类型的半指甲鞋垫作为PFFF中保守治疗的一部分，而不是彼此。