跳至主要内容
临床试验/NCT07234370
NCT07234370Enrolling By Invitation不适用

Distal Radial Fractures in Adult Patients: 4 Weeks Versus 6 Weeks of Cast Immobilization-A Randomized Controlled Trial

Liaquat National Hospital & Medical College1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年9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
80
试验地点
1
主要终点
Quick Disability of Arm, Shoulder, and Hand (Quick DASH)

研究概览

简要总结

Post-intervention outcomes comparing casting in distal radius fractures of four weeks versus six weeks.

详细描述

Cast immobilization for 6 weeks remains the mainstay of therapy for distal radius fractures. To challenge the therapeutic time frame, participants will be randomized into two arms, and the treatment arm will undergo immobilization for 4 weeks. Outcomes will be assessed at cast removal and then at 3 and 6 months prospectively using the Quick-DASH score and the DASH score (only at 6 months).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with DRF undergoing conservative management with cast immobilization
  • •Age between 18 to 50 years.

排除标准

  • •Any syndromic patients
  • •Any patients with musculoskeletal disease
  • •Patients having osteoporosis
  • •Post-menopausal females
  • •Ages less than 18 or greater than 50
  • •Patients presenting with intra-articular fractures

研究组 & 干预措施

Cast immobilization for six weeks

Active Comparator

Scotch cast immobilization for a period of six weeks applied to distal radius fractures

干预措施: Short Arm Cast for Distal Radius Fracture for six weeks (Procedure)

Cast immobilization for four weeks

Experimental

Scotch cast immobilization for a period of four weeks applied to distal radius fractures.

干预措施: Short Arm Cast for Distal Radius Fracture for four weeks (Procedure)

结局指标

主要结局

Quick Disability of Arm, Shoulder, and Hand (Quick DASH)

时间窗: Six weeks (Cast Removal)

Quick Disability of Arm, Shoulder, and Hand (Quick DASH) score is calculated using a formula based on responses to an 11-item questionnaire. Scores range from 0 to 100, where 0 indicates no disability and 100 indicates the most severe disability.

Quick Disability of Arm, Shoulder, and Hand (Quick DASH)

时间窗: 3 months after cast removal

Quick Disability of Arm, Shoulder, and Hand (Quick DASH) score is calculated using a formula based on responses to an 11-item questionnaire. Scores range from 0 to 100, where 0 indicates no disability and 100 indicates the most severe disability.

Disability of Arm, Shoulder, and Hand Score

时间窗: 6 months post-removal of cast immobilizations

The Disability of Arm, Shoulder, and Hand Score (DASH) is a 30-item questionnaire with scores ranging from 1 to 5 for each item. The final scores are formulated from 0 to 100, where a higher score indicates greater disability and a lower score indicates little to no disability.

Quick Disability of Arm, Shoulder, and Hand Score (Quick DASH)

时间窗: Four weeks (Cast Removal)

Quick Disability of Arm, Shoulder, and Hand (Quick DASH) score is calculated using a formula based on responses to an 11-item questionnaire. Scores range from 0 to 100, where 0 indicates no disability and 100 indicates the most severe disability.

Quick Disability of Arm, Shoulder, and Hand (Quick DASH)

时间窗: 6 months after cast removal

Quick Disability of Arm, Shoulder, and Hand (Quick DASH) score is calculated using a formula based on responses to an 11-item questionnaire. Scores range from 0 to 100, where 0 indicates no disability and 100 indicates the most severe disability.

次要结局

  • Palmar Flexion(6 months post-cast immobilization removal.)
  • Dorsiflexion(6 months post-cast immobilization removal.)
  • Radial Deviation(6 months post-cast immobilization removal)
  • Ulnar Deviation(6 months post-cast immobilization removal.)

研究者

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

Mohammad Zeeshan Haider

Resident Doctor

Liaquat National Hospital & Medical College

研究点 (1)

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