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临床试验/NCT04484584
NCT04484584已完成不适用

The Effect of Complex Decongestive Treatment on Edema and Hand Functions in Patients With Distal Radius Fracture

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Volumetric test measurement

研究概览

简要总结

Trauma results in inflammatory reactions accompanied by high protein edema. Trauma can also reduce the carrying capacity of the lymphatic system below normal lymphatic load, leading to exposure of lymphedema. Cellular wastes accumulated in interstitial fields and prolonged exudation period create a physiological problem. It causes the recovery time of tissues to be completed late and the functional gains to be delayed.

The aim of the study is to investigate the effect of Complex decongestive therapy on traumatic edema, pain and functionality.

详细描述

Patients are composed of patients who are referred to the physical medicine and rehabilitation clinic. All patients eligible for the study were informed about treatment and possible risks, and a consent form was signed. Determined evaluations were made to the patients. After 3 weeks of treatment, patients will be invited to the controls and the long-term effects of the treatments will be investigated.

Patients with a diameter difference of more than 50 ml between two extremities and patients without Sudeck Atrophy will be included in the treatment.

The study was planned as a single blind with randomized control. The physiotherapist who performed the treatment received manual lymph drainage therapy training.

The patients were distributed to groups with a computer-based data distribution system. While the patients are sent for treatment, they are directed according to the first assessment. The person who performed the assessment and those who received treatment were planned differently.

The primary purpose of the study was to investigate the long-term effectiveness of complex decongestive therapy on traumatic edema, as well as to evaluate long-term hand functions. Other objectives are to investigate the long-term effects on range of motion, muscle strength, grip strength, pain, and daily living activities.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 45 years
  • Unilateral distal radius fracture treated with plaster cast
  • Begin treatment after (7-10) days after removing the plaster
  • At least 50 mL of the volume difference between the upper extremities
  • Having signed the consent form

排除标准

  • Associated ulna fracture
  • Pathological fracture
  • polytrauma
  • Bilateral fractures
  • With chronic kidney disease
  • The presence of infection

结局指标

主要结局

Volumetric test measurement

时间窗: 4. week

Volumetric test measurement is more than 50 mL, edema is considered to be present.

Michigan Hand Outcomes Questionnarie

时间窗: 4. week

The raw scale score for each of the six scales is the sum of the responses of each scale item. The raw score is converted to a score ranging from 0-100. The MHQ is scored using a general algorithm. The response categories for one of the questions is reversed and re-coded. For the Pain scale, a higher score indicates more pain. For the other five scales, higher scores indicate better hand performance.

Quick DASH

时间窗: 4. week

Quick DASH measures upper extremity functionality. Quick DASH score calculation is made as disability / symptom score: (\[n total score / n\] -1) x25. The options are 'no difficulty' 'mild difficulty' 'moderate difficulty' severe difficulty 'and' unable '. 'no difficulty' is zero points and 'unable' is four.

Patient Rated Wrist Evaluation

时间窗: 4. week

The PRWE allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales: Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.

次要结局

  • Dynamometer test(4.week)
  • Myometer test(4.week)

研究者

发起方
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tuba Altun

MSc,Physotherapist

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

研究点 (1)

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