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临床试验/NCT06138236
NCT06138236招募中早期 1 期

Comparison of ESWT and Collagen Hydrolyzed Peptides in the Treatment of Plantar Fascitiis

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
招募中
入组人数
84
试验地点
1
主要终点
VAS (Visuoanalogic scale)

研究概览

简要总结

Patients suffering from Plantar Fasciitis were randomized into three groups:

the first group underwent infiltration of Collagen Hydrolyzed Peptides, the second one underwent the ESWT treatment, the third one underwent a combination of the two treatments.

详细描述

Patients suffering from Plantar Fasciitis were randomized into three groups:

the first group underwent infiltration of Collagen Hydrolyzed Peptides, the second one underwent the ESWT treatment, the third one underwent a combination of the two treatments.

Aim of the study was to consider any difference in the outcome of the three groups of patients. The NRS and the AFAS score were considered for the outcome measurement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Plantar fascitiis Aged between 18 and 80 years old

排除标准

  • Previous surgery of the foot
  • Contraindications to ESWT

研究组 & 干预措施

Infiltration

Experimental

1. Infiltration of collagen hydrolyzed peptides

干预措施: Collagen hydrolyzed peptides (Drug)

ESWT(Extracorporeal Shockwave Therapy)

Experimental

ESWT (Extracorporeal Shockwave Therapy)

干预措施: Collagen hydrolyzed peptides (Drug)

Combination

Experimental

Combination of both treatments

干预措施: Collagen hydrolyzed peptides (Drug)

结局指标

主要结局

VAS (Visuoanalogic scale)

时间窗: Between recruitment and 30 days

Visuoanalogic Scale during walking. Range 0 (No pain) -10 (maximum pain)

AFAS (American Foot and Ankle Score) is the American Foot and Ankle Scale

时间窗: Between Recruitment and 15 days

It is a measurement of active ROM and deambulation of the patient. Range 0 (no function) -100 (perfect function)

AFAS is American Foot and Ankle Scale

时间窗: Between Recruitment and 60 days

It is a measurement of active ROM and deambulation of the patient (Range 0-100)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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