An interventional study of Percutaneous radiofrequency and Conventional radiofrequency in Percutaneous, Conventional and Radiofrequency, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
This study aims to compare percutaneous and conventional radiofrequency applications for the treatment of knee osteoarthritic pain.
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.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's enrollment of 50 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Tanta University is the lead sponsor of 987 studies on the registry; 313 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients will receive percutaneous radiofrequency.
Device: Percutaneous radiofrequency
Patients will receive conventional radiofrequency.
Device: Conventional radiofrequency
For the percutaneous radiofrequency treatment, a medium electrode size will be placed on either side of the knee: one skin electrode on the inside and one on the outside of the knee for 15 minutes.
For the conventional radiofrequency treatment, a 50 Hz sensory stimulation will be performed with a 10 cm, 22 gauge, 10 mm active tip radiofrequency cannula. After receiving the appropriate sensory and motor stimuli, a radiofrequency of 90°C will be applied for 90 s.
Degree of pain
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.
Time frame: 12th week post-procedure
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores
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.
Time frame: 12th week post-procedure
Patient satisfaction
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.
Time frame: 12th week post-procedure
Incidence of adverse events
Incidence of adverse events such as bleeding, neurological damage, infection, abnormal proprioception, numbness, paresthesia, and motor weakness will be recorded.
Time frame: 12th week post-procedure
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
Time frame: After the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author.
Ran from Jul 2024 to primary completion in Dec 2024, 5 months.
Of 1,143 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 5 months is below that.
Counting every sponsor, half of 1,285 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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