Percutaneous, Conventional, Radiofrequency, Knee Osteoarthritis, Pain
Conditions
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.
Interventions
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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores | 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. |
| Patient satisfaction | 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. |
| Incidence of adverse events | 12th week post-procedure | Incidence of adverse events such as bleeding, neurological damage, infection, abnormal proprioception, numbness, paresthesia, and motor weakness will be recorded. |
Countries
Egypt
Outcome results
None listed