跳至主要内容
临床试验/NCT04913935
NCT04913935已完成不适用

Investigation of Parameters of Trapeziometacarpal Joint Configuration and Tenar Muscles in Patients With TMC OA

Hacettepe University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年9月5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
24
试验地点
1
主要终点
Ultrasound-based muscle cross-sectional area of thenar muscles in this study will investigate in TMC OA patients and healthy subjects.

研究概览

简要总结

In this study, investigators aimed to investigate the morphometric parameters tenar muscles and joint configuration in patients with trapeziometacarpal osteoarthritis (TMC OA) osteoarthritis stages, thenar muscle parameters, radial subluxation rate, functional level and hand dexterity.

详细描述

Patients diagnosed with trapeziometacarpal osteoarthritis and healthy subjects will be included in the study. Thickness and cross-sectional area measurements of the thenar muscles of the patient and healthy volunteers will be performed by using Shimadzu SDU 1200-Pro ultrasound system with an 8-10 MHz linear probe. To improve the image quality and to avoid muscle compression, water immersion ultrasonography will be preferred and the hands will be positioned in a water-filled plastic container. The thenar muscles will be imaged in hands of each subject.

In this study, poster-anterior radiographic imaging will be performed. The osteoarthritis stage will be determined on the radiographic image. Three different measurements will be performed on radiography: radial subluxation of the first metacarpal base (RS), articular width (AW) of the first metacarpal, and the distance between the ulnar articular facet of the trapezium and the ulnar edge of the metacarpal (U). RS / AW ratio will be calculated.

Because TMC OA caused pain and affect performance, especially during grip activities in the osteoarthritis and control groups will be tested.

Grip strength will also be measured.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
35 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with trapeziometacarpal osteoarthritis who were between 35 and 75 years

排除标准

  • Patient with De'quervain tenosynovitis, trigger finger, entrapment neuropathy and who had undergone hand surgery were excluded.

结局指标

主要结局

Ultrasound-based muscle cross-sectional area of thenar muscles in this study will investigate in TMC OA patients and healthy subjects.

时间窗: through study completion, an average of 1 year

USG procedures will performed on patients with TMC OA and healthy volunteers. Cross-sectional area measurements of thenar muscles of patient and healthy volunteers will performed using a Shimadzu SDU 1200-Pro ultrasound system with 8-10 MHz linear probe. USG device will calibrated prior to the study. Water bath technique for USG evaluation will preferred in order to improve the image quality and to avoid muscle compression. The hands will positioned in a 60x50x40 cm water-filled plastic container. Five thenar muscles will imaged in the hands of each subject: Opponens pollicis, abductor pollicis brevis, flexor pollicis brevis, first dorsal inteosseous and adductor pollicis muscles. Images will acquired in the cross-sectional planes. 2 evaluators blinded to each other will measure 15 minutes apart. With the first evaluator, it will measure for the second and third times at 30-minute intervals from the first measurement.

Ultrasound-based muscle thickness of thenar muscles in this study will investigate in TMC OA patients and healthy subjects.

时间窗: through study completion, an average of 1 year

USG procedures will performed on patients with TMC OA and healthy volunteers.Thickness measurements of thenar muscles of patient and healthy volunteers will performed using a Shimadzu SDU 1200-Pro ultrasound system with 8-10 MHz linear probe. USG device will calibrated prior to the study. Water bath technique for USG evaluation will preferred in order to improve the image quality and to avoid muscle compression. The hands will positioned in a 60x50x40 cm water-filled plastic container. Five thenar muscles will imaged in the hands of each subject: Opponens pollicis, abductor pollicis brevis, flexor pollicis brevis, first dorsal inteosseous and adductor pollicis muscles. Images will acquired in the cross-sectional planes. 2 evaluators blinded to each other will measure 15 minutes apart. With the first evaluator, it will measure for the second and third times at 30-minute intervals from the first measurement.

次要结局

  • Pain Assessment(through study completion, an average of 1 year)
  • Grip strength measurement(through study completion, an average of 1 year)
  • Minnesota hand skill test(through study completion, an average of 1 year)
  • The radial subluxation rate of the first metacarpal.(through study completion, an average of 1 year)
  • Evaluation of functional status of hand(through study completion, an average of 1 year)
  • 9 Hole hand skill test(through study completion, an average of 1 year)
  • Pinch strength measurement(through study completion, an average of 1 year)

研究者

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

Feray Karademir

Research Asssistant

Hacettepe University

研究点 (1)

Loading locations...

相似试验