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临床试验/CTRI/2025/12/098682
CTRI/2025/12/098682尚未招募不适用

Incidence of Neuropathic Pain in Operated Traumatic Brachial Plexus Injury in Adults: A Long-Term Follow-up

voggu venkata vinay vivek1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年12月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
48
试验地点
1
主要终点
Pain Intensities

研究概览

简要总结

The study is titled Incidence of Neuropathic Pain in Operated Traumatic Brachial Plexus Injury in Adults A Long-Term Follow-up.

Traumatic brachial plexus injuries cause severe disability and neuropathic pain is a common complication. The prevalence and long-term characteristics of neuropathic pain after nerve reconstruction surgery are not well documented. This prospective observational study aims to evaluate its incidence, severity, and impact.

Earlier studies reported neuropathic pain in 50 to 76 percent of patients with brachial plexus injuries. Factors such as nerve avulsion, alcohol, smoking, and severity of injury are associated with higher risk. Neuropathic pain negatively affects quality of life and mood.

The aim of the present study is to evaluate the incidence and characteristics of neuropathic pain in adult patients who underwent nerve reconstruction for traumatic brachial plexus injury with at least two years of follow-up. The primary objective is to assess demographic and injury characteristics of patients with neuropathic pain. Secondary objectives are to measure pain severity using the DN4 scale, characterize pain using the Brief Pain Inventory Short Form and the Neuropathic Pain Symptom Inventory, and evaluate functional performance using the Australian modified Karnofsky Performance Scale.

The study design is prospective observational. The sample size is 48, calculated based on a prevalence of 69 percent with adjustment for dropout. Inclusion criteria are adults aged 15 to 65 years with surgically treated traumatic brachial plexus injury confirmed by history, examination, electromyography, and surgical exploration. Exclusion criteria include medical management only, comorbid diseases that may cause neuropathic pain, and primary surgery performed more than one year after injury.

Patients will undergo baseline and follow-up evaluations using DN4, BPI-SF, AKPS, NPSI, and visual analog scale for pain. Pain intensity, symptoms, and location will be assessed longitudinally. Surgical interventions include exploration and reconstruction with nerve grafts and transfers.

Statistical analysis will be done using SPSS version 23 with chi square for categorical variables and t test or ANOVA for grouped variables. A p value less than 0.05 will be considered significant.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • All operated Adult Traumatic brachial plexus injury Age range of 15-65 years old Diagnosed as TBPI by history, physical examination, electromyography and the surgical exploration.

排除标准

  • Medical management diagnosed with any other disease that may cause neuropathic pain.
  • primary nerve surgery performed greater than one year since injury.

结局指标

主要结局

Pain Intensities

时间窗: At this cross section past 2years since surgery how are the pain parameters is analysed

Pain Symptoms

时间窗: At this cross section past 2years since surgery how are the pain parameters is analysed

Pain Locations

时间窗: At this cross section past 2years since surgery how are the pain parameters is analysed

次要结局

  • Quality of life(At this cross section past 2years since surgery how is the quality of life of patient is analysed)

研究者

发起方
voggu venkata vinay vivek
申办方类型
Other [Self(Primary Investigator)]
责任方
Principal Investigator
主要研究者

voggu venkata vinay vivek

Department of Hand surgery,Kasturba Medical College,Manipal

研究点 (1)

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