Efficacy of Ultra-sound Guided Peri-neural Platelet Rich Plasma Injection in Treatment of Chemotherapy Induced Peripheral Neuropathy: Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in severity of pain after injection
研究概览
简要总结
This study aims to show the efficacy and safety of ultra-sound guided peri-neural platelet rich injection in treatment of chemotherapy induced peripheral neuropathy.
详细描述
This study is prospective, randomized, assessor blinded controlled trial. It is aims to study the effect of perineural platelet rich plasma injection in cancer patients with prepheral neuropathy despite of stoppage chemotherapy for 6 months and usage of medical treatment.
Ultrasound-guided PRP injection will be performed after preparation of plasma obtained from the patient by using 10-19 MHz high frequency linear transducer to scan the superficial nerves.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cancer patients with peripheral neuropathy confirmed by clinical evaluation and nerve conduction study despite of medical treatment
排除标准
- •patients with:
- •Foot ulcers and / or amputation.
- •Peripheral vascular disease.
- •Uncontrolled diabetes
- •Vertebral pathologies.
- •Connective tissue diseases.
- •Thyriod disorders, significant renal or hepatic dysfunction.
- •Platelet dysfunction syndrome, critical thrombocytopenia.
- •Septicemia and local infection at the site of the procedure.
- •Systemic corticosteriod adminstiration or local injection at the suspected treatment site within the last month.
- •Recent fever or illness.
- •Hemoglobin level less than 10 g/dl, platelet count less than 105-109/L.
研究组 & 干预措施
platelet rich plasma
patients will be injected perineural platelet rich plasmawith 1.5 to 3 ml around each affected nerve
干预措施: platelet rich plasma (Drug)
contact group
only medical treatment in form of opioid and NSAIDs will be used
干预措施: platelet rich plasma (Drug)
结局指标
主要结局
Change in severity of pain after injection
时间窗: baseline, 15 days, 1 month, 2 months, 3 months
Change in severity of pain after prp injection wii be assessed using a 10-cm Visual Analog Scale (0 = no pain and 10 =worst imaginable pain
次要结局
- The functional Asseeement of Cancer Therapy/Gynecological Cancer Group-Neurotoxicity questionnaire (FACT/GOG-Ntx)(baseline, 15 days, 1 month, 2 months, 3 months)
- Nerve conduction study(baseline, 3 months)
- A 7- point Likert like verbal rating scale(baseline, 15 days, 1 month, 2 months, 3 months)
- total neuropathy score(baseline, 15 days, 1 month, 2 months, 3 months)
研究者
Nayira Mahmoud El-Husseini
Assistant lecturer of Anesthesia, ICU and pain releis
South Egypt Cancer Institute