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临床试验/NCT06761950
NCT06761950已完成不适用

Early Photobiomodulation Therapy on Pain and Range of Motion Following Flexor Tendon Repair

Cairo University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年8月1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
44
试验地点
1
主要终点
Assessment of change of pain intensity

研究概览

简要总结

The purpose of the study was to evaluate the therapeutic effect of low-level laser in improving pain and ROM following flexor tendon repair surgery.

详细描述

Flexor tendon injury is a common issue requiring early postoperative mobilization. Prolonged immobilization can lead to complications such as muscle atrophy, joint stiffness, osteoarthritis, infection, pain, joint cartilage ulceration, joint contracture, and tendon rupture. Low level laser therapy has been shown to accelerate inflammation, promote fibroblast proliferation, regulate procollagen messenger ribonucleic acid synthesis, accelerate bone repair and remodeling, encourage wound revascularization, and accelerate tissue repair. This study aims to evaluate the effectiveness of Low level laser therapy in pain management and improving range of motion after flexor tendon repair.

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 (Participant)

入排标准

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

入选标准

  • Forty-four patients of both genders with age ranged between 20 to 50 years will participate in this study.
  • All patients with zone II and III flexor tendon injuries, will be suffered from pain following flexor tendon repair surgery.
  • All patients with zone II and III flexor tendon injuries, will be suffered from limitation of range of motion deficiency following flexor tendon repair surgery
  • All patients enrolled to the study will have their informed consent.

排除标准

  • A wound in the affected area
  • Rheumatoid arthritis.
  • Epilepsy or any psychological disorders
  • Myelopathy or radiculopathy
  • exposed hand tendons.
  • Concomitant finger fractures, joint injuries, replantation or revascularizations, extensor tendon injury or crush injuries.
  • Impairment of cognitive, perceptual or psychological function that would impede ability to follow verbal instruction.
  • Multiple injuries to one flexor tendon, simultaneous injuries to bone and extensor tendons, skin loss, noncompliant patients or patients under 10 years, and gross contaminations of wounds.
  • patients with tendon repair associated with a skin graft, nerve injury, arterial injury, systemic disease (e.g. diabetes mellitus), wound infection,

结局指标

主要结局

Assessment of change of pain intensity

时间窗: At baseline and after 4 weeks

The Visual Analogue Scale is a 100mm line used for pain measurement, validated for various conditions like sleep, anxiety, breathlessness, and pruritus intensity. It accurately reflects pain changes, is reusable, and sensitive to acute pain changes.

次要结局

  • assessment of change of active range of motion of metacarpophalangeal joint(At baseline and after 4 weeks)
  • assessment of change of active range of motion of proximal interphalangeal joint(At baseline and after 4 weeks)
  • assessment of change of active range of motion of distal interphalangeal joint(At baseline and after 4 weeks)

研究者

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

Rehab Hesham Mohamed El-Sheikh

principal investigator

Cairo University

研究点 (1)

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