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Clinical Trials/NCT04112264
NCT04112264
Unknown
Not Applicable

Effect of Monopolar Radiofrequency Ablation for Genicular Nerves Compared to Bipolar Radiofrequency Ablation Using Ultrasound in Treating Chronic Knee Osteoarthritis

Mansoura University1 site in 1 country50 target enrollmentOctober 4, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Knee Osteoarthritis
Sponsor
Mansoura University
Enrollment
50
Locations
1
Primary Endpoint
Osteoarthritis pain
Last Updated
5 years ago

Overview

Brief Summary

Radiofrequency ablation of the genicular nerves using ultrasound is safe and effective for treating intractable knee osteoarthritis pain by using either monopolar or bipolar radiofrequency ablation.

This technique is based on anatomical studies demonstrating that genicular nerves are accompanied by genicular arteries. Ultrasound-guided RF genicular ablation yielded both significant reductions in knee pain and improvements in functional capacity.

Detailed Description

The aim of this study is to compare between ultrasound guided monopolar and bipolar radiofrequency ablation in chronic knee osteoarthritis. Osteoarthritis of knee joint is one of the most common disease conditions with advanced age and leads to considerable morbidity in terms of pain, stiffness, limitation in functions, disturbance in sleep and psychological disturbance A diagnostic genicular nerve block (GNB) with local anesthetic is performed before RF genicular ablation, and a successful response to GNB is considered to indicate the need for RF genicular ablation

Registry
clinicaltrials.gov
Start Date
October 4, 2020
End Date
June 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Radiologic tibiofemoral Osteoarthritis (Kellgren-Lawrence grade 2-4).
  • Patients not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids.
  • Patients refused surgery.

Exclusion Criteria

  • Patient refusal.
  • Prior knee surgery.
  • Acute knee pain.
  • Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
  • Connective tissue diseases that affected the knee.
  • Anticoagulant medication use.
  • Local skin infection and sepsis at the site of intervention

Outcomes

Primary Outcomes

Osteoarthritis pain

Time Frame: basal value, at 1, 4, 12, 24 weeks post procedure

The mean changes from baseline levels of osteoarthritis pain using visual analogue scale used to measure pain intensity. It is 10 cm scale where 0 cm represent no pain and 10 cm represent the worst pain ever

Secondary Outcomes

  • Oxford Knee Score(basal value, at 1, 4, 12, 24 weeks post procedure)
  • The procedure time(from the start of advancement of the cannula to end of procedure.)
  • Patient satisfaction score(up to 24 weeks post procedure)
  • Changes in doses of rescue analgesics(up to 24 weeks post procedure)
  • The incidence of numbness(up to 24 weeks post procedure)
  • The incidence of paresthesia(up to 24 weeks post procedure)
  • The incidence of motor weakness(up to 24 weeks post procedure)
  • the proportion of successful responders(up to 24 weeks post procedure)

Study Sites (1)

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