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临床试验/NCT03601533
NCT03601533Unknown不适用

Prospective Study of the Efficacy of Ultrasound-guided Genicular Nerve Block With Phenol for the Treatment of Chronic Pain Due to Knee Osteoarthritis

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年6月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
15
试验地点
1
主要终点
Change from Baseline Pain score

研究概览

简要总结

Osteoarthritis (OA) is one of the most frequent causes of chronic pain, often intense, debilitating and responsible for a large percentage of the elderly. The disease affects about 10% of adults and the knees are the most affected joints. The diagnosis of OA in the knee is predominantly clinical, and can be confirmed by radiological examination. Systemic drugs are indicated before invasive procedures, but pharmacological therapies may offer limited benefits. Thermal radiofrequency lesions of genicular nerves has been used to relieve chronic knee pain, as adjuvant therapy, but with high costs and low availability in the public system. The use of phenol for peripheral analgesic blocks has emerged as a good option and at low cost and can be used in any service of Pain Treatment. The aim of the study is to evaluate the efficacy of 6% phenol for ultrasound-guided genicular nerves neurolysis for the treatment of patients with chronic knee pain due to osteoarthritis.

METHODS: A prospective study will be carried out with 15 patients with chronic pain (more than 4 months) and diagnosis of arthrosis by imaging, with pain intensity greater than 4 (from zero to 10) that will be submitted to ultrasound-guided genicular nerves block. The test block will be performed with 0.25% -1,5 mL bupivacaine on each nerve. Patients who present pain improvement> 50% will undergo neurolysis of genicular nerves with 1,5 mL of 7% phenol in each of the genicular nerves. After the procedure, the patients will be evaluated for 3 months in relation to the intensity of pain at rest and movement and duration of analgesia provided by the intervention, range of movements and functionality of the knee joint.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Signature of the free, informed consent form
  • Age over 18 years old
  • Knee pain for more than six months without improvement with clinical treatment
  • Clinical and imaging diagnosis (radiography) of knee osteoarthritis
  • Moderate pain intensity (pain greater than 4, by the numerical scale).

排除标准

  • Cognitive impairment or psychiatric disease
  • Other causes of knee pain (trauma, complex regional pain syndrome)
  • Puncture site infection
  • Coagulopathy or use of anticoagulant.

研究组 & 干预措施

Phenol

Other

Patients will undergo neurolysis of genicular nerves with 1,5 mL of 7% phenol in each of the genicular nerves (superior, medial and lateral).

干预措施: Phenol (Drug)

结局指标

主要结局

Change from Baseline Pain score

时间窗: 15 days, 1 month, 2 months and 3 months after the procedure.

Patients will be evaluated before the procedure (baseline) and for 3 months in relation to the intensity of pain at rest and movement . The numeric pain scale from 0 (best condition) to 10 (worst condition) will be used to evaluate the patients.

次要结局

  • Change from Baseline WOMAC score(15 days, 1 month, 2 months and 3 months after the procedure)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leonardo Henrique Cunha Ferraro

Professor

Federal University of São Paulo

研究点 (1)

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