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Completed

NCT Number: NCT06520371

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous radiofrequency

Device

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.

Conventional radiofrequency

Device

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.

Primary outcomes

  1. Degree of pain

    Time frame: 12th 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 outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores

    Time frame: 12th 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.

  2. Patient satisfaction

    Time frame: 12th 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.

  3. Incidence of adverse events

    Time frame: 12th week post-procedure

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

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Comparison of Percutaneous and Conventional Radiofrequency Applications for the Treatment of Knee Osteoarthritic Pain: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2024
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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