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临床试验/NCT06296017
NCT06296017招募中不适用

Effectiveness of Conservative Interventions in the Treatment of Trigger Finger

Hacettepe University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
54
试验地点
1
主要终点
Visual analog scale

研究概览

简要总结

There is no study in the literature comparing the effectiveness of ESWT and splint therapy, which are the most commonly used approaches in the treatment of Trigger Finger (TF). The aim in this study is to investigate the effectiveness of ESWT and splint therapy used in the treatment of TF.

详细描述

Volunteer patients who were clinically diagnosed with trigger finger by consulting a doctor at Etlik City Hospital, Hand Surgery Clinic will be included in the randomized controlled prospective study. Patients will be randomly divided into three groups using the 'Random Sequence Generator tab' on Random.org, a randomization website, and different treatment programs will be applied. ESWT application to a group; splint treatment with ESWT to the second group; The third group will receive only splint treatment. ESWT application will be performed on A1 puley at 15 Hz, 1000 shock wave impuls and 2.0 bar level, for a total of 5 sessions, one week apart. In addition to ESWT with the same parameters, a trigger finger splint that immobilizes the MCP joint will be recommended to the ESWT and splint treatment group. The patient will be asked to use this splint throughout the day for 8 weeks. The Splint Group will be offered the same trigger finger splint and will be asked to use it throughout the day for 8 weeks. Evaluation and measurements will be repeated for all three groups before treatment, immediately after treatment (8th week) and 4 weeks after the end of treatment (12th week). The number of individuals to participate in the study was calculated as 54 in total, with 18 people in each group (ESWT Group, ESWT+ Splint Group and Splint Group), according to the power and sample size analysis based on 80% power and 5% Type 1 error rate. Power analysis was performed based on pain intensity as the clinical endpoint.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Volunteering
  • •Being between the ages of 18-65
  • •Being diagnosed with stage 1 or stage 2 (according to the Froimson classification) trigger finger
  • •Having the language and cognitive skills to answer the questionnaires used in the evaluation

排除标准

  • •Being pregnant
  • •Having an inflammatory disorder
  • •Having had surgery on the hand/wrist
  • •Having a neurological disease
  • •NSAIDs, painkillers, etc. being on medication
  • •De Quervain's tenosynovitis, carpal tunnel syndrome

研究组 & 干预措施

Extracorporeal Shock Wave Therapy

Experimental

Extracorporeal Shock Wave Therapy (ESWT for short) application will be performed on A1 pulley at 15 Hz, 1000 shock wave impulses, and 2.0 bar level, for a total of 5 sessions, one week apart.

干预措施: Experimental: Extracorporeal Shock Wave Therapy (Other)

Trigger Finger Splint

Experimental

A trigger finger splint that immobilizes the MCF joint will be recommended for the splint treatment group. The patient will be asked to use this splint throughout the day for 8 weeks.

干预措施: Trigger Finger Splint (Other)

Extracorporeal Shock Wave Therapy+Trigger Finger Splint

Experimental

Splint treatment will be applied together with ESWT. ESWT application will be performed on A1 pulley at 15 Hz, 1000 shock wave impulses, and 2.0 bar level, in a total of 5 sessions, one week apart. A trigger finger splint that immobilizes the MCF joint will be recommended for the splint treatment group. The patient will be asked to use this splint throughout the day for 8 weeks.

干预措施: Extracorporeal Shock Wave Therapy+ Trigger Finger Splint (Other)

结局指标

主要结局

Visual analog scale

时间窗: pre-treatment and post-treatment at 8 week

The severity of pain felt by individuals at rest and during challenging activities will be evaluated using the Visual Analog Scale (VAS). The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

次要结局

  • Functional assessment(pre-treatment and post-treatment at 8 weeks)
  • Treatment satisfaction(pre-treatment and post-treatment at 8 weeks)
  • Number of trigger(pre-treatment and post-treatment at 8 weeks)
  • Grip and pinch strength(pre-treatment and post-treatment at 8 weeks)

研究者

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

Feray Karademir

Principal Investigator

Hacettepe University

研究点 (1)

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