Main data.

BackgroundRadial extracorporeal shock wave therapy (r-ESWT) is accepted as one of the most effective treatment modalities for plantar fasciitis (PF). Also kinesio taping (KT) applicationis effective for the treatment of PF. However, there is not enough evidence about the effectiveness of the combination of these two modalities in the treatment of PF. This prospective randomized clinical trial was planned to investigate the acute effects of KT application in addition to r-ESWT application on pain, foot function and flexibility.MethodsThe study was performed on 42 patients with unilateral PF, that were randomly assigned into two groups receiving four sessions of either r-ESWT or r-ESWT+KT treatment once per week. All patients performed home exercises. Patients’ pain levels were evaluated via the Visual Analogue Scale (VAS), and foot function via the Foot Function Index (FFI). Flexibility was evaluated through gastro-soleus and plantar fascia flexibility tests. The evaluations were done before and one week after the final treatment. Two Way Analysis of Variance with Repeated Measures and Generalized Estimating Equations (GEE) methods were used in statistical analyses.ResultsAs a result, rest pain and activity pain decreased in both groups and there is no differences between the groups (respectively p: 0,831; p: 0.331). FFI pain and disability subscores decreased and were also similar between the groups (respectively p: 0.304; p: 0.978). FFI activity limitation subscore decreased in the r-ESWT group more than r-ESWT+KT group (p: 0.002). Night pain, gastro-soleus and plantar fascia flexibility did not change in both goups (respectively p: 0.713; p: 0.413; p: 0.475).ConclusionAdding KT to r-ESWT application did not create an additional pain relieving effect, on the contrary, resulted in less improvement in activity limitation. This may be related to the fact that KT application to the sole and heel region creates a hard surface on the heel. r-ESWT application may be more beneficial in PF where activity limitation are prominent.ClinicalTrials.govThe registration number: NCT06516393

背景 径向体外冲击波疗法（radial extracorporeal shock wave therapy, r-ESWT）已被公认为治疗足底筋膜炎（plantar fasciitis, PF）最有效的干预方式之一。肌内效贴（kinesio taping, KT）同样对PF的治疗具有明确疗效，但目前关于二者联合应用治疗PF的有效性证据仍相对不足。本前瞻性随机临床试验旨在探讨在r-ESWT基础上加用KT对患者疼痛、足部功能及柔韧性的急性影响。
方法 本研究纳入42例单侧PF患者，采用随机分组法将其分为两组，分别接受每周1次、共4个疗程的r-ESWT治疗，以及r-ESWT联合KT治疗，所有患者均同步完成居家锻炼。采用视觉模拟评分法（Visual Analogue Scale, VAS）评估患者疼痛程度，以足部功能指数（Foot Function Index, FFI）评估足部功能；通过腓肠比目鱼肌及足底筋膜柔韧性测试评估肢体柔韧性。分别于末次治疗前及末次治疗后1周完成上述评估。统计学分析采用重复测量两因素方差分析及广义估计方程（Generalized Estimating Equations, GEE）方法。
结果 两组患者的静息痛与活动痛均较前缓解，组间差异无统计学意义（分别对应p=0.831、p=0.331）。FFI的疼痛与残疾亚评分均有所降低，且组间无显著差异（分别对应p=0.304、p=0.978）。但r-ESWT组的FFI活动受限亚评分改善程度优于r-ESWT+KT组（p=0.002）。两组患者的夜间痛、腓肠比目鱼肌及足底筋膜柔韧性均无明显变化（分别对应p=0.713、p=0.413、p=0.475）。
结论 在r-ESWT基础上加用KT并未带来额外的疼痛缓解获益，反而导致患者活动受限的改善效果更差。这可能与KT贴敷于足底及足跟区域后在足跟处形成硬质接触面有关。对于活动受限症状突出的PF患者，单纯r-ESWT治疗或许更为有益。
临床试验注册 本研究在ClinicalTrials.gov的注册编号为NCT06516393。