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临床试验/NCT04332471
NCT04332471进行中(未招募)不适用

Treatment of Plantar Fasciitis With Radial Shockwave Therapy vs. Focused Shockwave Therapy: a Randomized Controlled Trial

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2020年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
114
试验地点
1
主要终点
Visual analog scale pain - morning

研究概览

简要总结

Inflammation of the plantar fascia is known as plantar fasciitis and is commonly seen in active or overweight individuals. It can be treated via conservative or surgical therapies. Extracorporeal shockwave therapy has shown promise in the treatment of plantar fasciitis. Several studies have compared the effects of different types of extracorporeal shockwave therapy (radial and focused) with other forms of conservative treatment in patients with chronic plantar fasciitis. No study has yet compared the effect of radial vs. focused shockwave therapy on pain in this population.

详细描述

Plantar fasciitis is a common foot problem that affects 3.8 per 1,000 persons in the United States. It is characterized by inflammation of the plantar fascia, a fibrous tissue which connects the calcaneus to the metatarsal heads, and is often seen in individuals who are overweight and/or participate frequently in weight-bearing endurance activities such as running. Pain is typically at its highest during the first steps in the morning, although it can also occur with prolonged weightbearing. Plantar fasciitis can be treated via conservative or surgical measures, although surgery is considered as the last resort. In recent years, extracorporeal shockwave therapy has emerged as an alternative conservative method for treating plantar fasciitis. There are two types -- radial and focused shockwave therapy. Focused therapy creates deeper-penetrating, higher-energy shockwaves, whereas radial therapy produces more superficial shockwaves that can treat a wider area of pathology.

Randomized controlled trials have compared focused and radial shockwave therapy to placebo and other conservative measures in the treatment of chronic plantar fasciitis and overall demonstrated benefit. Only one study has directly compared radial and focused shockwave therapy in this population, although pain was not an outcome of focus in the study. The current study aims to collect patient-reported outcomes on both pain and function following radial vs. focused shockwave therapy vs. control therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients presenting with a clinical diagnosis of chronic plantar fasciitis (>3 months) that has been recalcitrant to other treatments
  • Minimum VAS pain of 40/100 (4/10; morning pain when taking first steps, pain after prolonged walking/standing)
  • English-speaking

排除标准

  • Cortisone injection within the past 3 months
  • Platelet-rich plasma injection within the past 6 months
  • History of previous foot surgery
  • Bilateral heel pain
  • Coagulopathies or use of anti-coagulants
  • Local and systemic neurologic or vascular insufficiencies
  • Rheumatologic disorders
  • Systemic inflammatory disorders
  • Active or chronic infection in the area
  • Lower extremity bone disorders (e.g., Paget's disease, osteomyelitis)
  • Calcaneal fractures
  • Nerve entrapment
  • Ruptures in tendon
  • Non-English speaking

研究组 & 干预措施

Control

Active Comparator

Patients in the control group will be treated using the home therapy protocol only.

干预措施: Home therapy (Other)

Radial shockwave therapy

Active Comparator

Patients will receive 4 sessions of radial shockwave therapy.

干预措施: Home therapy (Other)

Radial shockwave therapy

Active Comparator

Patients will receive 4 sessions of radial shockwave therapy.

干预措施: Radial shockwave therapy (Procedure)

Radial shockwave therapy

Active Comparator

Patients will receive 4 sessions of radial shockwave therapy.

干预措施: Shockwave therapy device (Device)

Focused shockwave therapy

Active Comparator

Patients will receive 4 sessions of focused shockwave therapy.

干预措施: Focused shockwave therapy (Procedure)

Focused shockwave therapy

Active Comparator

Patients will receive 4 sessions of focused shockwave therapy.

干预措施: Shockwave therapy device (Device)

Focused shockwave therapy

Active Comparator

Patients will receive 4 sessions of focused shockwave therapy.

干预措施: Home therapy (Other)

结局指标

主要结局

Visual analog scale pain - morning

时间窗: Up to 1 year

Morning pain. This will be assessed on a scale of 0-100, with a higher score representing more pain.

Visual analog scale pain - after prolonged walking or standing

时间窗: Up to 1 year

Pain after prolonged walking or standing. This will be assessed on a scale of 0-100, with a higher score representing more pain.

次要结局

  • Foot and Ankle Outcome Score (FAOS)(Up to 1 year)
  • PROMIS Physical Function computer adaptive test score(Up to 1 year)
  • Treatment satisfaction(Up to 1 year)

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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