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临床试验/NCT03918434
NCT03918434已完成不适用

Efficacy of a Locoregional Anesthesia Technique During High Energy Extracorporeal Shock Wave Therapy for Painful Foot Disease: a Pilot Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2019年6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
21
试验地点
1
主要终点
Number of patients who reported a reduction of pain during High Energy Shock Wave Therapy with posterior nerve block

研究概览

简要总结

Plantar fasciitis and the chronic Achilles tendinopathy are the most common causes of heel pain. The term "plantar fasciitis" implies an inflammatory condition by the suffix "itis". However, various lines of evidence indicate that this disorder is better classified as "fasciosis" or "fasciopathy", as heel pain associated with degenerative changes in the fascia and atrophy of the abductor minimi muscle. High energy shock wave therapy (HESWT) has been proposed as a potential method of treating patients with chronic disease without the need to stop weightbearing. Often a crucial complication of HESWT is the appearance of pain with the subsequent interruption of the procedure. The consequences are a reduced patient compliance, need of a deep sedation and more sessions for the treatment.

Frequently, topic anesthesia (TA) (as EMLA) is applied during the therapy to decrease the pain HESWT-induced and enable sham treatment. Multiple publications focused on the evaluation of a clinically relevant effect of shock wave application on plantar heel pain, either of HESWT, applied in a single session with local or regional anesthesia or of low energy HESWT, applied repetitively without local anesthesia.

Rompe JD and colleagues have demonstrated that the therapeutic success rate of HESWT with TA is significantly smaller than without TA even after 3 months. Probably, the use of anesthetic topically applied can reduce the efficacy of HESWT for increased impedance. To date, many patients interrupted the HESWT for moderate-severe pain. Consequently, this therapy, which generally is administered in three sessions, required a prolongation of procedure up to six sessions.The clinical application of Posterior Tibial nerve block (already widely used in operating room) during HESWT applied in Orthopedic Day Hospital could offer the possibility to minimize the patient discomfort and to give the therapeutic doses just in few HESWT sessions, reducing the hospital access of outpatients for the treatments and the costs related to prolonged treatment caused by pain. Furthermore, this anesthetic approach could make patients tolerate majorated doses of HESWT in few sessions, with high effectiveness of procedure after several months.

详细描述

The aim of this pilot prospective observational study is to allow outpatients with chronic Achilles tendinopathy and plantar fasciitis to reduce the pain during HEWST. The study will be focused on the evaluation of a posterior tibial nerve block efficacy in patients who discontinued the first application of HESWT due to surge of moderate-severe pain.

Objectives of the study Primary objective The primary objective of the study is to observe a 40% reduction in Numerical Rating Scale (NRS) from baseline (T0) to T1 during HESWT.

Secondary objectives: evaluation of the number of patients that are able to complete a single session with Posterior tibial nerve block (usually, without Posterior tibial nerve block, 40% of patients can not complete the session); evaluation of the number of sessions required to complete successfully the treatment (usually, without Posterior tibial nerve block, the number of sessions required to complete successfully the treatment is 6); evaluation of the efficacy of HESWT (American Orthopedic Foot and Ankle Society Score - AOFAS, performed 1 month from the end of treatment).

Design of the study This is an observational, pilot, prospective, cohort study. It will be conducted in Orthopedic Day Hospital Ward of "Fondazione-Policlinico Universitario A. Gemelli IRCCS" of Rome. The planned duration of the study is 6th months and the proposed sample size is N:21.

Materials and Methods The enrollment starts after the patient interrupt his/her first HESWT treatment (T0) because the pain is unbearable with NRS>5. Before the second HESWT session (T1) patients will receive the posterior tibial nerve block (PTNB) under ultrasound control. This anesthetic procedure will be repeated for every subsequent HESWT session. After each treatment, the patient will be monitored in Orthopedic Day hospital ward for about 2 hours or until complete sensitive recovery. At the end of each session the patient will be asked to express his/her pain intensity using the NRS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • • History of Chronic Achilles tendinopathy and/or plantar fasciitis at least 6 months long
  • Unsatisfying subjective result (Numeric Rating Scale (NRS) score persistently ≥ 4 points for pain during the first few steps of walking in the morning) after at least 6 months after ≥ 3 of the following 5 conventional therapy programs: ≥ 4 weeks of physical therapy; ≥4 weeks course of non-steroidal anti-inflammatory medications
  • HESWT indication
  • Application of HESWT at 1500 shock waves with energy of 16 Ky
  • First treatment discontinued for surge of pain (numeric rating scale [NRS] > 5)

排除标准

  • • Patient < 18 years
  • Peripheral circulatory disorders
  • Arthrosis of the foot or ankle, as confirmed by X-ray diagnosis
  • Skin lesions of the foot
  • Allergy to local anesthetic
  • Neurologic abnormality (changes of deep tendon reflexes, motor or sensory deficit)
  • Routinely consumption of analgesics or history of analgesic consumption within 24 hours prior to therapy.

结局指标

主要结局

Number of patients who reported a reduction of pain during High Energy Shock Wave Therapy with posterior nerve block

时间窗: 6th months

The primary objective of the study is to observe a 40% reduction in Numerical Rating Scale before and after posterior tibial nerve block during shock wave therapy. Intensity of pain at the end of each procedure will be measured by Numerical Rating Scale (NRS) between 0 and 10 points, where Zero usually represents 'no pain at all' whereas ten represents 'the worst pain ever possible.

次要结局

  • Number of shock wave sessions(6th months)
  • Number of patients who completed the session of shock wave therapy(6th months)
  • Number of patients with clinical efficacy of shock wave therapy evaluated by American Orthopedic Foot and Ankle Society Score (AOFAS)(7th months)

研究者

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

SPINAZZOLA GIORGIA

Medical doctor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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