Percutaneous Needle Tenotomy Associated With Platelet-rich Plasma Injection Platelet-rich Plasma in the Treatment of Refractory Plantar Fasciitis: a Pilot Study of the Effect on Pain and Tolerance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- To evaluate the evolution of plantar pain after treatment combining needle tenotomy and PRP injection in refractory plantar fasciitis.
研究概览
简要总结
There are various treatments for plantar fasciitis, including physical therapy, orthopedic inserts or steroid infiltrations. However, it is estimated that about 20% of patients do not respond to first-line treatment [Rompe, Sports Med Arthrosc Rev, 2009]. It is therefore necessary to be able to integrate new treatments into the management of this condition. The objective of the study is to assess the effect on pain and the safety of the percutaneous ultrasound-guided tenotomy associated with a platelet rich plasma injection to treat refractory plantar fasciitis.
详细描述
- Pre-inclusion visit (consultation for scheduling the procedure) After verification of the inclusion criteria, the investigating rheumatologist will inform the patient of the study and give him/her the information note. The patient will be offered a period of reflection before signing the consent form. As the procedure requires prior precautions, this will allow the patient to become aware of them. The patient will be given a prescription for a walking boot and a pair of walking sticks.
- Inclusion visit (D0)
After verification of all the inclusion and non-inclusion criteria, the following examinations will be performed during the inclusion visit before the procedure:
- Signature of the consent by the patient and the investigator
- Interrogatory including collection of concomitant treatments, evaluation of the walking perimeter, evaluation of sports activities
- Clinical examination of the foot (Heel tenderness index)
- Standard X-ray of the foot (if not performed at screening)
- Plantar ultrasound = echogenicity of the plantar aponeurosis, measurement of thickness in mm, search for hypervascularization by Doppler
- VAS pain during activity
- FAAM self-questionnaire
- Procedure in 3 steps:
- Local anesthesia by tibial block 60 minutes before the tenotomy
- Venous sampling of 10 ml and centrifugation for 5 minutes
- Needle tenotomy and injection of 1 ml of PRP at the end of the procedure
- Prescription of enoxaparin at a preventive dose for 7 days
The tolerance of the procedure will be evaluated immediately after the procedure, using a VAS for pain. This will be collected by a nurse. We will also collect the acceptability of the procedure as well as the immediate complications (vagal discomfort, bleeding at the injection site).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
To evaluate the evolution of plantar pain after treatment combining needle tenotomy and PRP injection in refractory plantar fasciitis.
时间窗: 6 months
VAS pain at activity
次要结局
- Evaluate the tolerance of the procedure(6 weeks, 3 months, 6 months)
- Evaluate the evolution of pain when pressing the insertion of the plantar fascia(6 weeks, 3 months, 6 months)
- Evaluate the acceptability of the procedure(6 weeks, 3 months, 6 months)
- Evaluate the evolution of the functional discomfort(6 weeks, 3 months, 6 months)
- Evaluate the evolution of the ultrasound data(6 weeks, 3 months, 6 months)
- Evaluate the return to sports activities(6 weeks, 3 months, 6 months)