Pulsed Radiofrequency Therapy vs Canal Adductor Blockade in Knee Osteoarthritis

NCT ID: NCT05962463

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-09
• Study Completion Date: 2025-06-30

Brief Summary

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.

Detailed 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.

Conditions

Knee Osteoarthritis

Keywords

Adductor canal blockade; Radiofrequency therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Canal adductor blockade

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.

Canal adductor blockade

Intervention Type: PROCEDURE

The same experienced anesthesiologist has performed all blocks. Always after surgical cleaning of the anteromedial thigh, all participants in this group received single shot ultrasound guided canal adductor blockade. After the blockade, all participants were monitored in our ambulance for the next hour.

Pulsed radiofrequency therapy

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.

Canal adductor pulsed radio-frequency therapy

Intervention Type: PROCEDURE

The same experienced anesthesiologist has performed all PRF therapy After surgical cleaning of the anteromedial thigh, all participants in this group received ultrasound-guided pulsed radiofrequency therapy. We've 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 42ºC. After the treatment, all participants were monitored in our ambulance for the next hour.

Interventions

Canal adductor blockade

The same experienced anesthesiologist has performed all blocks. Always after surgical cleaning of the anteromedial thigh, all participants in this group received single shot ultrasound guided canal adductor blockade. After the blockade, all participants were monitored in our ambulance for the next hour.

Intervention Type: PROCEDURE

Canal adductor pulsed radio-frequency therapy

The same experienced anesthesiologist has performed all PRF therapy After surgical cleaning of the anteromedial thigh, all participants in this group received ultrasound-guided pulsed radiofrequency therapy. We've 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 42ºC. After the treatment, all participants were monitored in our ambulance for the next hour.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Mensur Salihovic

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mensur Salihovic

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

University Medical Centre

Ljubljana, , Slovenia

Site Status: RECRUITING

Countries

Slovenia

Central Contacts

Mensur Salihovic, MD

Role: CONTACT

Phone: +38640208892

Email: mensur.salihovic@kclj.si

Mensur Salihovic

Role: CONTACT

Phone: +38640208892

Email: mensur.salihovic@kclj.si

Facility Contacts

Mensur Salihovic

Role: primary

References

Arendt-Nielsen L, Nie H, Laursen MB, Laursen BS, Madeleine P, Simonsen OH, Graven-Nielsen T. Sensitization in patients with painful knee osteoarthritis. Pain. 2010 Jun;149(3):573-581. doi: 10.1016/j.pain.2010.04.003. Epub 2010 Apr 24.

Reference Type: BACKGROUND

PMID: 20418016 (View on PubMed)

Ikeuchi M, Ushida T, Izumi M, Tani T. Percutaneous radiofrequency treatment for refractory anteromedial pain of osteoarthritic knees. Pain Med. 2011 Apr;12(4):546-51. doi: 10.1111/j.1526-4637.2011.01086.x. Epub 2011 Apr 4.

Reference Type: BACKGROUND

PMID: 21463469 (View on PubMed)

Salihovic M, Rijavec B, Muratagic A, Blagus R, Puh U. Effectiveness of Ultrasound-Guided Canal Adductor Blockade for Chronic Pain and Functioning in Knee Osteoarthritis: A Prospective Longitudinal Observational Study. Biomed Res Int. 2022 Jan 22;2022:5270662. doi: 10.1155/2022/5270662. eCollection 2022.

Reference Type: BACKGROUND

PMID: 35103237 (View on PubMed)

Burckett-St Laurant D, Peng P, Giron Arango L, Niazi AU, Chan VW, Agur A, Perlas A. The Nerves of the Adductor Canal and the Innervation of the Knee: An Anatomic Study. Reg Anesth Pain Med. 2016 May-Jun;41(3):321-7. doi: 10.1097/AAP.0000000000000389.

Reference Type: BACKGROUND

PMID: 27015545 (View on PubMed)

Akbas M, Luleci N, Dere K, Luleci E, Ozdemir U, Toman H. Efficacy of pulsed radiofrequency treatment on the saphenous nerve in patients with chronic knee pain. J Back Musculoskelet Rehabil. 2011;24(2):77-82. doi: 10.3233/BMR-2011-0277.

Reference Type: BACKGROUND

PMID: 21558611 (View on PubMed)

Carpenedo R, Al-Wardat M, Vizzolo L, Germani G, Chine E, Ridolfo S, Dauri M, Natoli S. Ultrasound-guided pulsed radiofrequency of the saphenous nerve for knee osteoarthritis pain: a pilot randomized trial. Pain Manag. 2022 Mar;12(2):181-193. doi: 10.2217/pmt-2021-0035. Epub 2021 Aug 25.

Reference Type: BACKGROUND

PMID: 34431329 (View on PubMed)

Zhang H, Wang B, He J, Du Z. Efficacy and safety of radiofrequency ablation for treatment of knee osteoarthritis: a meta-analysis of randomized controlled trials. J Int Med Res. 2021 Apr;49(4):3000605211006647. doi: 10.1177/03000605211006647.

Reference Type: BACKGROUND

PMID: 33887985 (View on PubMed)

Uematsu H, Osako S, Hakata S, Kabata D, Shintani A, Kawazoe D, Mizuno K, Fujino Y, Matsuda Y. A Double-Blind, Placebo-Controlled Study of Ultrasound-Guided Pulsed Radiofrequency Treatment of the Saphenous Nerve for Refractory Osteoarthritis-Associated Knee Pain. Pain Physician. 2021 Sep;24(6):E761-E769.

Reference Type: BACKGROUND

PMID: 34554694 (View on PubMed)

Gupta A, Huettner DP, Dukewich M. Comparative Effectiveness Review of Cooled Versus Pulsed Radiofrequency Ablation for the Treatment of Knee Osteoarthritis: A Systematic Review. Pain Physician. 2017 Mar;20(3):155-171.

Reference Type: BACKGROUND

PMID: 28339430 (View on PubMed)

Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.

Reference Type: RESULT

PMID: 21055873 (View on PubMed)

Other Identifiers

0120-464/2022/6

Identifier Type: -

Identifier Source: org_study_id