跳至主要内容
临床试验/NCT06296472
NCT06296472招募中不适用

De Quervain's Disease in the Acute Phase: Randomized Interventional Study Aimed at Evaluating the Effectiveness of Standard Physiotherapy Treatment (HANDGUIDE), Compared to Experimental Treatment After Performing Ultrasound-guided Infiltrative Therapy.

Istituto Ortopedico Rizzoli2 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2024年2月27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
134
试验地点
2
主要终点
Numeric Pain Rating Scale

研究概览

简要总结

The objective of the study is to compare pain reduction and disability reduction in two groups of patients diagnosed with de Quervain syndrome who will undergo ultrasound-guided infiltrative treatment with corticosteroid as per normal clinical practice:

  • the control group will subsequently be subjected to a standard treatment based on the European guidelines of the HANDGUIDE group,
  • the experimental group will subsequently carry out a program of eccentric exercises.

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)

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

  • Patients of both sexes with a minimum age of 18 years;
  • Medical diagnosis of de Quervain syndrome assessed through orthopedic clinical examination e confirmation by ultrasound;
  • Signing of the informed consent and participation in the study.

排除标准

  • Patients who are not self-sufficient or not able to understand and want;
  • Presence of other pathologies in the hand affected by de Quervain pathology, such as intersection syndrome, neuropathies, fractures, rhizoarthrosis, arthrosis of the radio-carpal or intercarpal joint, intercarpal instability, cervical radiculopathy, rheumatic or metabolic pathologies;
  • Pregnant or breastfeeding women.

研究组 & 干预措施

Standard

Active Comparator

干预措施: Standard (Other)

Experimental

Experimental

干预措施: Rehabilitation (Other)

结局指标

主要结局

Numeric Pain Rating Scale

时间窗: After 6 months

An 11-point Numeric Pain Rating Scale (NPRS) ranging from 0 to 10 was anchored on the left with the phrase "No Pain" and on the right with the phrase "Worst Imaginable Pain." Patients rated their current, best, and worst level of pain during the last 24 hours.

Numeric Pain Rating Scale

时间窗: At baseline (day 0)

An 11-point Numeric Pain Rating Scale (NPRS) ranging from 0 to 10 was anchored on the left with the phrase "No Pain" and on the right with the phrase "Worst Imaginable Pain." Patients rated their current, best, and worst level of pain during the last 24 hours.

Numeric Pain Rating Scale

时间窗: After 1 month

An 11-point Numeric Pain Rating Scale (NPRS) ranging from 0 to 10 was anchored on the left with the phrase "No Pain" and on the right with the phrase "Worst Imaginable Pain." Patients rated their current, best, and worst level of pain during the last 24 hours.

Numeric Pain Rating Scale

时间窗: After 3 months

An 11-point Numeric Pain Rating Scale (NPRS) ranging from 0 to 10 was anchored on the left with the phrase "No Pain" and on the right with the phrase "Worst Imaginable Pain." Patients rated their current, best, and worst level of pain during the last 24 hours.

次要结局

  • Disabilities of Arm, Shoulder and Hand(After 6 months)
  • Patient-Rated Wrist Evaluation(After 6 months)
  • Disabilities of Arm, Shoulder and Hand(At baseline (day 0))
  • Disabilities of Arm, Shoulder and Hand(After 1 month)
  • Disabilities of Arm, Shoulder and Hand(After 3 months)
  • Patient-Rated Wrist Evaluation(At baseline (day 0))
  • Patient-Rated Wrist Evaluation(After 1 month)
  • Patient-Rated Wrist Evaluation(After 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验