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临床试验/NCT06712329
NCT06712329已完成不适用

Chronic Plantar Fasciitis: Which is More Effective? Prolotherapy/Extracorporeal Shock Wave Therapy?

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Visual Analogue Scale(VAS)

研究概览

简要总结

The primary objective of this prospective study was to compare the effects of ESWT (extracorporeal shock wave therapy ) and prolotherapy on pain and foot function in patients with chronic plantar fasciitis. In addition, the study was to investigate the changes in plantar pressure distribution and plantar fascia thickness measured by ultrasonography after ESWT and prolotherapy.

The fundamental questions that investigators want to answer are as follows:

[question 1]:Do ESWT and prolotherapy improve pain and foot function in patients with chronic plantar fasciitis? [question 2]:Do ESWT and prolotherapy change plantar pressure distribution and plantar fascia thickness in patients with chronic plantar fasciitis?

详细描述

Chronic plantar fasciitis is a prevalent musculoskeletal disorder that results in discomfort and impaired functionality within the plantar surface of the foot. In instances where conservative treatment proves ineffective, it can complicate the management of the condition. Two invasive treatment options, namely extracorporeal shock wave therapy (ESWT) and prolotherapy, are available for the management of plantar fasciitis, with the objective of providing pain and functional improvement. The objective of this study was to compare the effects of ESWT and prolotherapy on pain, foot function, plantar fascia thickness and plantar pressure distribution in patients with chronic plantar fasciitis.

A total of 70 patients who did not respond to conservative treatment were included in this prospective, randomised controlled study. Following a clinical and ultrasonographic evaluation, the patients were randomly assigned to one of two groups. The study population was divided into two groups: the ESWT group (n = 36) and the prolotherapy group (n = 34). In the ESWT group, a total of 1800 to 2000 focused shock waves (0.15-0.25 mJ/mm² sessions with a frequency of 3-4 Hz) were applied. The prolotherapy group was administered a 3-ml injection of a 15% dextrose solution. The ESWT and prolotherapy treatments were administered in a total of three sessions, with two-week intervals between each session. The efficacy of the treatment was evaluated using a number of different measures, including the Visual Analogue Scale (VAS), the Foot and Ankle Ability Measurement (FAAM), the thickness of the plantar fascia and the distribution of plantar pressure. The evaluations were conducted at the outset of the study, at the six-week mark, and at the 12-week mark following the final intervention.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • participants must be aged between 18 and 75 years
  • they must have experienced heel pain for a period of at least three months
  • they must exhibit pain and tenderness upon palpation of the medial aspect of the calcaneal tuberosity with the ankle in full dorsiflexion
  • they must have demonstrated no response to conservative treatment for a minimum of three months.
  • In cases where symptoms were present on both sides, the more prominent side was included.

排除标准

  • Inflammatory rheumatic disease
  • Dermatological lesion on the heel
  • Coagulopathy
  • Peripheral circulatory disorder
  • A neurological disorder, such as radiculopathy or polyneuropathy
  • Previous ESWT, dextrose prolotherapy, or surgical procedure to the heel region
  • A local corticosteroid injection or oral corticosteroids in the last six weeks.

结局指标

主要结局

Visual Analogue Scale(VAS)

时间窗: baseline - 6th week-12th week

The Visual Analogue Scale (VAS) was employed to evaluate the general perception of pain and the pain experienced at the first step upon rising. The scale ranges from 0 to 10, with a score of 0 indicating no pain and a score of 10 indicating the most severe pain imaginable

次要结局

  • Plantar pressure distribution(baseline - 6th week-12th week)
  • Foot and Ankle Ability Measure (FAAM)(baseline - 6th week-12th week)
  • Thickness of the plantar fascia(baseline - 6th week-12th week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayşe Ukbe Baykut

Medical Doctor

Ankara City Hospital Bilkent

研究点 (2)

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