Heigh Evelyn, Bohman Laura, Briskin Gary, Slayton Michael, Amodei Richard, Compton Keegan, Baravarian Bob
Podiatric Surgeon, Summit Medical Group Arizona, Glendale, AZ.
Podiatric Surgeon, Podiatry Associates of Cincinnati, Cincinnati, OH.
J Foot Ankle Surg. 2019 May;58(3):519-527. doi: 10.1053/j.jfas.2018.10.002. Epub 2019 Mar 23.
Intense therapeutic ultrasound for chronic plantar fasciitis musculoskeletal tissue pain reduction was evaluated in a pivotal clinical trial examining effectiveness, safety, and patient tolerance. In this single-blinded study, 33 patients received 2 treatments that were 4 weeks apart on plantar fascia tissue along with conservative standard of care. Patients were followed for up to 6 months after the first treatment, receiving a physical examination and diagnostic ultrasound at each follow-up visit and completing patient-/subject-reported outcome measure and Foot Function Index surveys. The goal was to reduce overall pain by ≥25% on average and >25% individually. Hypoechoic area changes on diagnostic ultrasound and adverse events were measured. The percentage meeting pain reduction criteria at weeks 4, 8, 12, and 26 were 72%, 81%, 86%, and 79%, respectively. Mean pain scores at each visit were significantly different from baseline (p < .001) at -39%, -49%, -51%, and -44%. Hypoechoic lesions were found in all patients and decreased in size significantly (p < .05) at weeks 8 and 12 (-56% and -67%). Foot Function Index scores declined favorably from baseline (p < .001) at all time points (-32%, -46%, -49%, and -32%). The percentages of patients meeting satisfaction criteria were 72%, 85%, 90%, and 83%. The mean pain score during treatment 1 was 3.4, and during treatment 2, 2.9. Attrition of only 1 patient owing to pain occurred, after treatment 1. No adverse events occurred. Intense therapeutic ultrasound for chronic plantar fasciitis is shown to be effective, safe, and well tolerated in this pivotal clinical trial.
在一项评估疗效、安全性和患者耐受性的关键临床试验中，对用于减轻慢性足底筋膜炎肌肉骨骼组织疼痛的高强度治疗性超声进行了评估。在这项单盲研究中，33名患者在接受保守标准护理的同时，在足底筋膜组织上接受了两次间隔4周的治疗。首次治疗后对患者进行长达6个月的随访，每次随访时进行体格检查和诊断性超声检查，并完成患者/受试者报告的结局指标和足部功能指数调查。目标是平均将总体疼痛减轻≥25%，个体减轻>25%。测量诊断性超声上的低回声区变化和不良事件。在第4、8、12和26周达到疼痛减轻标准的百分比分别为72%、81%、86%和79%。每次随访时的平均疼痛评分与基线相比有显著差异（p <.001），分别降低了-39%、-49%、-51%和-44%。在所有患者中均发现了低回声病变，在第8周和第12周时病变大小显著减小（p <.05）（分别减小了-56%和-67%）。足部功能指数评分在所有时间点均较基线有显著改善（p <.001）（分别降低了-32%、-46%、-49%和-32%）。达到满意度标准的患者百分比分别为72%、85%、90%和83%。治疗1期间的平均疼痛评分为3.4，治疗2期间为2.9。仅1名患者在治疗1后因疼痛退出。未发生不良事件。在这项关键临床试验中，高强度治疗性超声治疗慢性足底筋膜炎显示出有效、安全且耐受性良好。
