Chronic Knee Osteoarthritis
Conditions
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
Interventions
PROCEDUREMonopolar radiofrequency ablation
a radiofrequency cannula is advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia along the area of knee joint supplied by that respected genicular nerve by stimulation at 50 Hz current of \<0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.
PROCEDUREBipolar radiofrequency ablation
Two radiofrequency cannula are advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia by stimulation at 50 Hz current of \<0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Osteoarthritis pain | 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
| Measure | Time frame | Description |
|---|---|---|
| The procedure time | from the start of advancement of the cannula to end of procedure. | The procedure time taken by each mode of radiofrequency from the start of advancement of the cannula under US guidance to the end of the procedure. |
| Patient satisfaction score | up to 24 weeks post procedure | Patient satisfaction score with treatment which is scored from 1 to 10. A score of 1-4 was considered dissatisfied, 5-8 was satisfied, and 9 or 10 was very satisfied |
| Changes in doses of rescue analgesics | up to 24 weeks post procedure | — |
| Oxford Knee Score | basal value, at 1, 4, 12, 24 weeks post procedure | A specific score to assess the functional changes in the knee using Oxford Knee Score (OKS). The scores are 12-item questionnaires ranging from 12-60, with 12 representing the optimal outcome. |
| 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 | the proportion of successful responders with a reduction of at least 50% of median VAS score and no increase from baseline OKS |
| The incidence of numbness | up to 24 weeks post procedure | — |
Countries
Egypt
Contacts
Primary ContactSherif A Mousa, MD
Backup ContactOla T Abd El-Dayem, MD
Outcome results
None listed