跳至主要内容
临床试验/NCT01509274
NCT01509274Unknown4 期

Treatment of Plantar Fasciitis With Injection af Platelet-rich Plasma Into the Origin of the Plantar Fascia - a Prospective, Randomized and Double Blinded Study.

Kolding Sygehus2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2011年8月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
90
试验地点
2
主要终点
Pain on a VAS score

研究概览

简要总结

The purpose of our study is to determine whether one injection with plasma into the origin of the plantar fascia is an effective treatment of plantar fasciitis.

90 patients will be randomized into three groups. 30 patients will be treated with one plasma injection, 30 patients will be treated with one injection with saline and 30 patients will do physiotherapy and use heel cups. The two groups who receive injections will do the same physiotherapy and use heel cups, as the conservatively treated group.

Both groups randomized to receive an injection will have a 10 ml blood sample taken from their cubital vein. The sample is centrifuged for 5 minutes at 5000 rpm. No additives are added. 3 ml of plasma i obtained, and the syringe i blinded. Is the patient randomized to receive an injection with saline, a similar syringe is blinded with 3 ml of saline. The injection into to the origin of the plantar fascia i done 10 minutes after the sample of blood is obtained. The content of the syringe i blinded to both the investigator and the patient.

The injection i performed from the medial aspect of the heel under guidance of ultrasound. No local/systemic analgetic is used. The content of the syringe is spread using peppering technique into the origin of the plantar fascia.

Patients will do questionnaires at inclusion and after 1, 2, 3, 6 and 12 months. The questionaires will be Foot Function Index and SF-36 as well as questions about their use of analgetics, use of heel cups and intensity of their physiotherapy

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • between 18 and 70 of age
  • Sore at the insertion of the plantar fascia on calcaneus
  • A VAS score of at least 4 at the insertion of the plantar fascia on calcaneus taking the first step in the morning
  • Symptoms for 6 to 12 months
  • Ability to understand danish and give informed consent

排除标准

  • Previously operated in the same ankle or foot
  • Pain anywhere else in the foot on palpation otherwise than at the insertion of the plantar fascia on calcaneus
  • Inflammatory disease
  • Formerly rupture of the Achilles tendon
  • Formerly treated with plasma injections
  • Ongoing infection treated with antibiotics
  • Treated with steroid during the trial
  • Treatment of the plantar fasciitis exceeding conservative treatment
  • Use of crutches, walker or similar
  • Pregnancy

结局指标

主要结局

Pain on a VAS score

次要结局

  • Disability

研究者

发起方
Kolding Sygehus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bjørn Nedergaard

Cand. Med.

Kolding Sygehus

研究点 (2)

Loading locations...

相似试验