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Percutaneous vs Conventional Radiofrequency Applications for the Treatment of Knee Osteoarthritic Pain

Not Applicable
Completed
Conditions
Knee Osteoarthritis
Percutaneous
Radiofrequency
Pain
Conventional
Interventions
Device: Conventional radiofrequency
Device: Percutaneous radiofrequency
Registration Number
NCT06520371
Lead Sponsor
Tanta University
Brief Summary

This study aims to compare percutaneous and conventional radiofrequency applications for the treatment of knee osteoarthritic pain.

Detailed Description

Osteoarthritis (OA) is a progressive degenerative joint disease that affects the joint cartilage and surrounding tissues. It mostly affects the weight-bearing joints, and in this respect, the knee joint is one of the joints that is most affected.

Radiofrequency (RF) treatment has been used for several painful conditions such as trigeminal neuralgia, cancer pain, and spinal pain. To destroy nerves or disrupt the transmission of pain signals, originally using producing heat lesions, RF current is applied to the trigeminal ganglion, the spinothalamic tracts of the spinal cord, the medial branches of posterior rami, and the dorsal root ganglion. In addition to these, there have been a few attempts to apply RF current for the treatment of painful conditions of joints of the extremities.

Percutaneous radiofrequency ablation (RFA) of articular sensory nerves has recently emerged as an attractive and minimally invasive approach to treat chronic pain due to large-joint osteoarthritis in select patients.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
50
Inclusion Criteria
  • Age > 18 years old.
  • Both sexes.
  • Patients with knee osteoarthritis.
  • Previous conservative treatments longer than 3 months.
  • Visual analog scale (VAS)≥ 4.
  • Radiological osteoarthritis grades 3 and 4 according to the Kellgren-Lawrence grading system (0 = none, 1 = doubtful, 2 = minimal, 3 = moderate, and 4 = severe).
Exclusion Criteria
  • Prior knee surgery.
  • Allergies to local anesthetics.
  • Connective tissue diseases affect the knee.
  • Serious neurologic or psychiatric disorders.
  • Injection with steroids or hyaluronic acids during the previous 3 months.
  • History of septic arthritis.
  • Sciatic pain.
  • Cardiac pacemaker users.
  • Anticoagulant medications.
  • Prior electroacupuncture treatment.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Conventional radiofrequency groupConventional radiofrequencyPatients will receive conventional radiofrequency.
Percutaneous radiofrequency groupPercutaneous radiofrequencyPatients will receive percutaneous radiofrequency.
Primary Outcome Measures
NameTimeMethod
Degree of pain12th week post-procedure

Degree of pain will be assessed using visual analog scale (VAS). Each patient will obtain a score between 0 and 10 (Zero means no pain, and ten means the worst pain). VAS will be assessed pre-procedure and post-procedure 2nd, 6th, and 12th week.

Secondary Outcome Measures
NameTimeMethod
Incidence of adverse events12th week post-procedure

Incidence of adverse events such as bleeding, neurological damage, infection, abnormal proprioception, numbness, paresthesia, and motor weakness will be recorded.

Patient satisfaction12th week post-procedure

Degree of patient satisfaction will be assessed on a 5-point Likert scale Patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied ; 5, extremely satisfied). It will be assessed pre-procedure and post-procedure 1, 4, and 12th week.

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores12th week post-procedure

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores: range from 0 to 96 (0 represents the best health status and 96 the worst possible status). The higher the score, the poorer the function. It will be assessed pre-procedure and post-procedure 1, 4, and 12th week.

Trial Locations

Locations (1)

Tanta University

🇪🇬

Tanta, El-Gharbia, Egypt

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