跳至主要内容
临床试验/CTRI/2024/05/068225
CTRI/2024/05/068225尚未招募Phase 3 4

Comparative evaluation of ultrasound guided pulsed radio frequency treatment of saphenous nerve and genicular nerve block vs genicular nerve block alone for patients with knee joint osteoarthritis pain: a prospective randomized study

Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
VAS (Visual Analogue Scale) score: VAS score for pain is calculated using a 0 to 10 cm horizontal line, where 0 corresponds to no pain and 10 to severe pain. The patient is asked to mark his or her current pain on this line. The point where the patient has marked on this line is measured and reported as the score. The validated Hindi version of VAS scores will be used for the patients who do not understand English language.

研究概览

简要总结

Osteoarthritis of the knee joint is a troublesome disease particularly in the elderly population. It is characterized by pain and stiffness of the knee joint. its management include lifestyle modifications, use of paracetamol, non-steroidal anti-inflammatory disease, and total knee replacement in resistant cases. Interventional treatment employs the use of nerve blocks and intraarticular supplementation to provide pain relief to these patients. The knee joint is supplied by genicular branches of femoral, tibial, common peroneal, saphenous and obturator nerves. Genicular nerve blocks have been used in these patients with satisfactory short-term outcomes. Pulsed radiofrequency of peripheral nerves is being utilized to enhance the analgesic efficacy of nerve blocks. The present study hypothesizes that combination of pulsed radiofrequency of saphenous nerve and genicular nerve block is better than genicular nerve block alone to relieve the pain of knee joint osteoarthritis. This study will be conducted in 60 patients divided randomly into 2 equal groups of 30 each. One group will be given combined pulsed radiofrequency of saphenous nerve and genicular nerve block and another group genicular nerve block alone. The pulsed radiofrequency of the saphenous nerve will be done at 42⁰C and 45 V for 8 minutes under ultrasound guidance. The ultrasound guided genicular nerve block of 3 nerves i.e.  superomedial, superolateral and inferomedial genicular nerves will be done with 1 ml of 0.5% bupivacaine.  These patients will be evaluated with visual analogue score (VAS) and Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) score at baseline, 1 week, 1 month, 3-month and 6-month post procedure to assess the efficacy of the procedures. Any adverse effects experienced by the patients will also be recorded during the study period.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with complaints of knee pain of osteoarthritis origin (Kallgren Lawrence grade 2-4) Patients who failed conservative treatment for at least 3 months.

排除标准

  • The patients with a history of knee surgery, trauma, or any inflammatory systemic diseases.
  • Patients with history of corticosteroid therapy in last 3 months.
  • Patients not willing for follow-up.

结局指标

主要结局

VAS (Visual Analogue Scale) score: VAS score for pain is calculated using a 0 to 10 cm horizontal line, where 0 corresponds to no pain and 10 to severe pain. The patient is asked to mark his or her current pain on this line. The point where the patient has marked on this line is measured and reported as the score. The validated Hindi version of VAS scores will be used for the patients who do not understand English language.

时间窗: Pre-procedure and 1 week, 1 month, 3-month, 6-month and 12-month post-procedure

WOMAC (Western Ontario McMaster Universities Osteoarthritis Index) score: The WOMAC score is calculated by patient reporting it’s score in three categories: pain (five questions, possible subscale scores 0–20), stiffness (two questions, 0–8), and physical functioning (17 questions, 0–68), with a minimum score of 0, and a maximum score of 96. The validated Hindi version of WOMAC scores will be used for the patients who do not understand English language.

时间窗: Pre-procedure and 1 week, 1 month, 3-month, 6-month and 12-month post-procedure

次要结局

  • NA(NA)

研究者

发起方
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sandeep Khuba

Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow

研究点 (1)

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