Pulsed Radiofrequency Therapy vs Canal Adductor Blockade in Knee Osteoarthritis

University Medical Centre Ljubljana

Status: Enrolling

Conditions: Knee Osteoarthritis

Treatments: Procedure: Canal adductor blockade; Procedure: Canal adductor pulsed radio-frequency therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05962463

0120-464/2022/6

Details and patient eligibility

About

This study is intended to prove the efficacy and safety of ultrasound-guided pulsed radiofrequency therapy on adductor canal nerves by patients with Knee osteoarthritis.

Full description

Knee osteoarthritis is a serious epidemiologic problem. Non-surgical methods are shown limited efficacy in relieving chronic knee pain in patients in advanced stages of knee osteoarthritis. The knee prosthesis is a successful treatment for many patients with advanced knee osteoarthritis. Still, there are important numbers of patients, which are not appropriate candidates for such surgery treatment or refused surgery for any reason. For them, any treatment which could relieve pain in their knee would have a good impact on their quality of life. Interventions like adductor canal block(ACB) and pulsed radiofrequency therapy (PRF) have demonstrated good results. In this study, investigators compare the effectiveness of these two methods. Official approval from the ethics committee of the Republic of Slovenia was obtained for this study. After being informed about the research and potential risks, all patients giving written informed consent will undergo an orthopedic examination and those with a confirmed diagnosis of knee osteoarthritis that lasted more than 6 months will be included in the study. All participants were randomly divided into two groups. Participants in the first group receive single shot ACB and participants in the second group receive PRF therapy at the same point. Before starting all patients filled the Knee injury and osteoarthritis outcome(KOOS) form and estimated the maximal and minimal intensity of pain in the knee. They repeat self-assessment of pain, in the same manner, using 11 points numeric rating score(NRS) 1 month, 3, and six months after the blockade or PRF therapy. Measurement of maximum voluntary isometric contraction of the quadriceps muscle (MVIC), time up and go test(TUG), and 30s stand-up chair test are performed by a physiotherapist before a block of adductor canal on both legs,1 hour, 1 month, 3 months and 6 months after a block or PRF therapy.The adductor canal blockl is performed by the same trained anesthesiologist at the proximal part of the leg using 14 ml of Levobupivacaine and 100 mcg of Clonidine mixed in the same syringeAfterof the study participants filled the Knee injury and osteoarthritis outcome(KOOS) form once again.

Enrollment: 128 estimated patients

Sex: All

Ages: 45 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnose of the Knee osteoarthritis confirmed by orthopedic examination
• K-L grades 3 and 4
• A sufficient level of education to understand study procedures
• Be able to communicate with site personnel
• Age >45 years

Exclusion Criteria :

• Any cardiovascular, hepatic, or renal conditions that would compromise participation, in the opinion of the investigator
• Severe neurologic conditions interfere with a knee condition
• Narcotic dependent (opioid intake of more than 3 months and more than 30 mg of daily oral morphine equivalents)
• Coexisting severe hematological disorder or deranged coagulation parameters
• Psychiatric illnesses
• Allergy to any of the drugs used in the study
• Infection or malignancy at the site of the block
• Any active systemic infection
• Implanted electronic devices like spinal cord stimulators, cardiac pacemakers or similar

Trial design

128 participants in 2 patient groups

Canal adductor blockade

Description:

After surgical cleaning of the anteromedial thigh, all participants in this group received single shot ultrasound guided canal adductor blockade with 14 ml 0,25% levobupivacaine and 100 mcg clonidine mixed in the same syringe. Investigators previously scanned the adductor canal and chose the middle of the canal as the entry point of the 10 cm echogenic ultrasound needle. After the blockade, all participants were monitored in our ambulance for the next hour.

Treatment:

Procedure: Canal adductor blockade

Pulsed radiofrequency therapy

Description:

After surgical cleaning of the anteromedial thigh, all participants in this group received ultrasound-guided pulsed radiofrequency therapy. Investigators previously scanned the adductor canal and chose the middle of the canal as the entry point of the RF 10 cm needle with a 1 cm free tip. After sensory and motor checking all patients have gotten 6 minutes of therapy divided into 3 sequences of 2 minutes of 50 V current and 42. Before starting the PRF therapy all participants have gotten 2 ml 0,25% levobupivacaine through the needle for preventing discomfort during the procedure. After the treatment, all participants were monitored in our ambulance for the next hour.

Treatment:

Procedure: Canal adductor pulsed radio-frequency therapy