跳至主要内容
临床试验/NCT06737601
NCT06737601Enrolling By Invitation不适用

ESWT vs Orthosis in Trigger Finger Treatment: Prospective Randomized Clinical Study

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
1
主要终点
recovery of pain

研究概览

简要总结

Recently, two works have proposed the application of Extracorporeal Shock Waves Therapy (ESWT) in the treatment of trigger finger. Yildirim and colleagues (2016) compared shock waves with corticosteroid infiltration. both methods proved effective at 6 months. The authors suggested that shock wave treatment could be a valid non-invasive therapy option for this pathology. Chen and colleagues (2021) analyzed two different shock wave protocols [high and low Energy Density Flux (EDF)] vs placebo. All treatment groups showed improvements within 6 months. The high-energy treatment (EDF 0.01 mj/mm2) demonstrated greater effects on clinical remission and functional recovery compared to the other two groups in the study. The aim of our study is to compare the effects of shock waves vs the use of the orthosis.

详细描述

Trigger finger, also called flexor digitorum stenosing tenosynovitis, is a pathological condition characterized by a size discrepancy between the flexor tendon/tendon sheath and the A1 pulley, located in the metacarpal head. This pathology causes pain and blockage of the flexion tendon of the finger, with a frequency of 2.6% in the general population, with a higher incidence in the female population, especially in the fifth and sixth decade. The 4th, 3rd and 1st fingers are most involved. trigger finger limits daily activities, such as grasping and holding objects with handles, manipulating coins and buttoning.

The diagnosis is based on the clinical history of transient locking of the finger when flexed with subsequent painful snapping when extended. The trigger phenomenon can be preceded by pain and joint stiffness. The instrumental study, with ultrasound and/or MRI, allows you to monitor the severity of the disease, identify the underlying cause and decide on the appropriate treatment. Surgical treatment should be reserved for those who do not respond to conservative treatment and desire definitive resolution.

A consensus was conducted to identify the consensus treatment guideline for trigger finger, including nonsteroidal anti-inflammatories, orthoses, corticosteroid infiltration and percutaneous release, and surgery. No evidence was found to support the use of nonsteroidal anti-inflammatory drugs. There has been evidence regarding the use of an orthosis, because by immobilizing the finger joint, it would prevent the occurrence of a trigger. Corticosteroid infiltration was effective, albeit with shorter-term effects than the orthosis, with high rates of relapses and exacerbations after 6 months. Surgical treatment is reserved for those who do not benefit from conservative therapy and need a definitive result.

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 (Investigator)

盲法说明

Given the nature of the therapy, it is not possible to blind the operators or patients. The medical staff responsible for collecting the disease scores, however, will be blind regarding the assignment of patients to one or the other group.

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

  • Grade 2~3 trigger finger according to Quinnell classification
  • problem that has been occurring for at least 3 months

排除标准

  • Previous treatment via physiotherapy, local corticosteroid injection or surgical release for trigger finger within 3 months prior to recruitment.
  • Presence of musculoskeletal disease or previous nerve injury to the upper extremities.
  • Multiple trigger finger.
  • contraindications to treatment with ESWT: local infection; epilepsy; malignant tumor; inflammatory arthritis; cardiac arrhythmia or cardiac pacemaker; and pregnancy.

研究组 & 干预措施

orthesis group

No Intervention

use of metacarpophalangeal orthosis for 4-6 weeks

ESWT group

Experimental

3 shock waves sessions, weekly, EDF 1500 pulses, 0.01-0,08 mJ/mm2 (Minilith SL1 Storz, Swiss)

干预措施: shock waves (Device)

结局指标

主要结局

recovery of pain

时间窗: From enrollment to 1, 3 and 6 months

The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

次要结局

  • Trigger frequency(From enrollment to 1, 3 and 6 months)
  • Quick-Disabilities of the Arm, Shoulder, and Hand (QuickDASH)(From enrollment to 1, 3 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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