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临床试验/CTRI/2024/08/072701
CTRI/2024/08/072701尚未招募4 期

Comparison of the efficacy of fluoroscopic guided continuous neuroablative versus pulsed neuromodulative radiofrequency of genicular nerves in patients of osteoarthritis knee

Government Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月23日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To compare the analgesic efficacy of CNARF versus PNMRF using visual analogue scale (VAS) in patients of osteoarthritis knee.

研究概览

简要总结

A total of 40 patients will be randomly allocated to either Group-C or Group-P, with 20  patients in each group.Group C (n=20): fluoroscopic guided continuous neuroablative radiofrequency of genicular nerves Group P (n=20): fluoroscopic guided pulsed neuromodulative radiofrequency of genicular nerves.

All patients will be explained about the procedure and positioned in supine position on the fluoroscopy table with the affected leg flexed by 30-40 degrees, using a bolster placed underneath the knee. The procedure will be performed under local anaesthesia at the site of needle insertion and will be given conscious sedation with midazolam 1-2 mg IV and or titrated dose of fentanyl (0.5-1 mcg/kg IV), as and when required. Sterile tray will be prepared constituting sterile gloves, disposable 10 ml syringes, 26 G 3 inch hypodermic needles, connection tubing, and 22 G RF needle. A mixture of ropivacaine and triamcinolone acetonide (7 ml of 0.2% ropivacaine and 80 mg of triamcinolone acetonide) under aseptic precautions will be prepared and will kept on sterile tray. Skin preparation will be done with povidone iodine solution (10%).

C-arm fluoroscope will be subsequently positioned to obtain imaging of knee joint in anteroposterior (AP) and lateral view. The procedure is guided using  fluoroscope and neurostimulation integrated in RF machine (COOLIEF RF GENERATORâ„¢). In the AP fluoroscopic view, the superior lateral and superior medial genicular nerve will be located at the confluence of the lateral and medial femoral shaft and the lateral and medial femoral condyle, respectively. The depth of the needle tip at the midpoint of the femur is further confirmed by  lateral fluoroscopic view.  The inferior medial genicular nerve was located at the confluence of the medial tibial shaft and the tibial flare by AP fluoroscopic view and further the needle tip depth at the midpoint of the tibia will be done by lateral fluoroscopic view.  Local infiltration of 1-2 ml of 2% lignocaine hydrochloride will be injected subcutaneously at each mentioned point of insertion of RF needle. For each genicular nerve, a 10 cm long, 22-G RF needle with a 10-mm active tip will be advanced under fluoroscopy with the assistance of anteroposterior and lateral knee imaging. Final position of the needles will be further confirmed by RF electrode by sensory (50 Hz, up to 1.0 V) and motor (2 Hz, 2.0 V) stimulation.   The settings of CNARF ablation of the target nerve will be carried out at 80°C and 20 V for 90 seconds and PNMRF will be carried out at 42°C and 45V with 3 cycles of 120 seconds at each genicular nerve

Following the RF procedure, 3 ml of sterile solution (7 ml of 0.2% ropivacaine and 80 mg of triamcinolone acetonide) prepared before, was administered at each of three RF lesion site before withdrawing the needle. A sterile dressing will be applied. Patients will be instructed to lie in a supine position after the procedure for next 30 minutes in the recovery room and vitals will be monitored.

Pain assessment of patient by VAS score, Functional improvement of the patient assessed by WOMAC score, Patient satisfaction level by Likert five point scale will be recorded at pre-intervention, 1, 2 and 3 month post-intervention. .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • Chronic knee pain of moderate to greater intensity with VAS score more than 3 for more than 3 months 2.Patients with radiological based Kellgren and Lawrence Grade 2, 3 and 4 osteoarthritis knee.

排除标准

  • Patients with acute knee pain
  • Patients with history of prior knee surgery
  • Patient with severe heart, lung, hepatic, renal, psychiatric, neurological, connective tissue disorder, uncontrolled diabetes mellites or hypertension
  • Patients who received intra articular knee injections with steroid or hyaluronic acid within last three months
  • Severe bleeding diathesis or on anticoagulation therapy
  • Patient with temporary or permanent cardiac pacemaker
  • Presence of systemic infection or local infection at the injection site
  • Significant allergic reaction or hypersensitivity to contrast, anaesthetic, or corticosteroids
  • Patient diagnosed with other malignancy
  • Patient on uncontrollable or unstable opioid use.

结局指标

主要结局

To compare the analgesic efficacy of CNARF versus PNMRF using visual analogue scale (VAS) in patients of osteoarthritis knee.

时间窗: Pain assessment of patient by VAS score at pre-intervention, 1, 2 and 3 month postintervention.

次要结局

  • 1. Comparison of functional improvement achieved by CNARF versus PNMRF using Western Ontario McMaster Universities‘ (WOMAC) index of osteoarthritis.(2. Comparison of participants satisfaction achieved by CNARF versus PNMRF using five point Likert scale.)

研究者

发起方
Government Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Satish Mahur

Government Medical College and Hospital Sector32 Chandigarh

研究点 (1)

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