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临床试验/NCT05032300
NCT05032300Unknown不适用

Shear Wave Elastography Technology to Evaluate the Efficacy of ESW in the Treatment of Patients With Chronic Plantar Fasciitis,a Single-blinded Randomised Controlled Trial

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Reduction in pain as assessed by a 0-10 visual analogue scale (VAS)

研究概览

简要总结

Inflammation of the plantar fascia is called plantar fasciitis and is common in active or overweight individuals. It can be treated conservatively or surgically. Extracorporeal shock wave therapy has shown significant efficacy in the treatment of plantar fasciitis. Repeated chronic inflammation of the plantar fascia may lead to fibrous edema, thickening and even calcification in the fascia, resulting in thickening of the plantar fascia in patients with chronic plantar fasciitis and affecting the mechanical properties of the plantar fascia (changes in elastic modulus) ). Previous studies rarely involved changes in the elasticity of the plantar fascia before and after extracorporeal shock wave treatment.

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 (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

  • Pain at the proximal calcaneal stop of the plantar fascia
  • The pain is severe when waking up in the morning or standing and walking after sitting for a long time, and it is slightly relieved after activities, and it will be aggravated after long walking or standing for a long time
  • Pain time> 3 months
  • Visual Scoring Scale (VAS)>4
  • The pain is tingling, sore, or burning, etc
  • There is or no tender point at the bottom of the arch of the foot
  • The patient has not undergone corticosteroid injection therapy or shock wave therapy or surgery
  • X-ray confirmed no calcaneal spurs
  • The patient agrees to participate in this study

排除标准

  • Suffering from calcaneal stress fracture, atrophy of fat pad, compression of the little toe abductor nerve (Baxter's nerve), tarsal tunnel syndrome, sciatica, bone or soft tissue tumor, rheumatism or rheumatoid arthritis, rigidity Those with spondylitis and infection
  • those who disagree with and do not understand the treatment methods or methods of the experiment
  • those with mental disorders

结局指标

主要结局

Reduction in pain as assessed by a 0-10 visual analogue scale (VAS)

时间窗: Up to six months

Patients can score a minimum of 0 and a maximum of 10. Getting a high score indicates a bad situation.

Elastic modulus and morphology of plantar fascia lesion area

时间窗: Up to six months

Sonoelastographic changes of plantar fascia after ESWT

次要结局

  • American Society of Foot and Ankle Surgery (AOFAS) Ankle and Hindfoot Function Score(Up to six months)

研究者

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

Yonggang Dou

Intermediate Physiotherapist

Nanfang Hospital, Southern Medical University

研究点 (1)

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