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临床试验/NCT06112145
NCT06112145已完成不适用

Are Rehabilitation Results in Flexor Tendon Zone II Injuries as Bad as Feared?

Kirsehir Ahi Evran Universitesi2 个研究点 分布在 2 个国家目标入组 78 人开始时间: 2023年11月1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
78
试验地点
2
主要终点
Range of motion

研究概览

简要总结

The hand is the basic functional organ of the human body and is responsible for complex tasks such as grasping and catching. It also plays an important role in a person's daily life, self-care activities and business life. When the flexor tendon system, which is necessary for the effective use of the hand, is damaged, it can cause physical, socioeconomic deterioration, mood disorders and permanent disabilities in the individual. Treatment of flexor tendon injuries after appropriate surgical repair ıt includes an intensive rehabilitation program. In this study, it was aimed to investigate the early rehabilitation results of patients who underwent a rehabilitation program after Zone II flexor tendon injury by comparing the improvements in joint range of motion, pain, functionality and quality of life with other zone injuries.

详细描述

Tendon cuts constitute a significant portion of hand injuries. Today, most flexor tendon ruptures are repaired the same day as the injury or a few days later. Rehabilitation after flexor tendon repair is at least as important as surgical repair. Hand rehabilitation protocol after tendon repair; It consists of four periods: 1-4 weeks early period, 4-6 weeks early intermediate period, 6-8 weeks intermediate period, 8-12 weeks late period. Modified Duran Protocol is one of the earliest passive mobilization methods. According to this protocol, it has been reported that 3-5 mm of passive movement of the tendon anastomosis is effective in preventing tendon adhesions. In the literature, the number of studies examining rehabilitation results in patients with flexor tendon zone II injuries is quite limited. Post-operative rehabilitation results are worse in patients with zone II tendon injuries compared to other flexor zone injuries. This study aimed to investigate the early rehabilitation results of patients who underwent a rehabilitation program after Zone II flexor tendon injury by comparing the improvements in joint range of motion, pain, functionality and quality of life with other zone injuries. 70 patients who applied to Ankara City Hospital Physical Therapy and Rehabilitation Hospital Traumatic Hand Clinic due to flexor tendon injury and met the inclusion criteria for the study will be included. Demographic characteristics of the patients (age, gender), occupation, cause of injury, injured hand, dominant hand, smoking, and injury zones will be recorded. Patients with zone II injuries Group I, Patients with other zone injuries will be divided into Group II. In this study, Modified Duran early passive mobilization protocol was used to protect the repaired tendon and reduce the risk of adhesion will be followed. The physiotherapist will advised each patient on the things to consider after the operation, orthosis use and care, and the rehabilitation process. Early passive mobilization exercises in the form of passive flexion and extension and edema massage will be taught to all fingers of the injured hand in a dorsal blocking orthosis and will be recommended to be applied every two hours during the day. Patient follow-up will last four weeks and afterwards, measurements will be repeated.

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 (Outcomes Assessor)

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

入选标准

  • Had a traumatic flexor tendon injury
  • In the acute period after repair (1-4 weeks)

排除标准

  • Accompanying fracture, dislocation, burn
  • infection, malignancy
  • Patients using steroid-nonsteroidal drugs and having cognitive dysfunction

结局指标

主要结局

Range of motion

时间窗: baseline and 4th week

Range of motion is one of the most commonly used outcome variables after hand tendon injuries and will be preferred because it provides objective information about the effectiveness of the treatment. Since this study covers the acute period after repair, the normal joint movement of the patients will be evaluated passively. The measurement will be made with a goniometer.

Visual Analog Scale

时间窗: baseline and 4th week

Pain intensity of patients at rest and during activity will be evaluated with a visual analog scale (VAS). For VAS evaluation, the meanings of the numbers from 0 to 10 placed on a 10 cm line were explained to the patients. It will be announced that no pain is 0 points, moderate pain is 5 points, and the most severe pain is 10 points. According to these explanations, the patient will be asked to mark the pain on a 10 cm line. Pain intensity will be determined by measuring the distance between the marked place and the starting point with a ruler.

次要结局

  • Duruoz Hand Index(baseline and 4th week)
  • Short Form-36(baseline and 4th week)

研究者

发起方
Kirsehir Ahi Evran Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nazife Kapan

Principal investigatör

Kirsehir Ahi Evran Universitesi

研究点 (2)

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