Pulsed Radiofrequency Therapy vs Canal Adductor Blockade in Knee Osteoarthritis

NCT05962463 | Recruiting DMC

• 1 other identifier: 0120-464/2022/6
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Adductor canal blockade; Radiofrequency therapy

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Change From Baseline in Maximal and minimal Pain on the 11-point Numeric rating score Pain Scale (NRS 0-11) ;Numeric 11-point rating score is widely accepted self-reported score for measurement of chronic and acute pain in researches.Possible scores range are between 0-free of pain and 10-the worst imaginable pain.

  Baseline ,1 hour,1 month, 3 month and 6 months

• KOOS

  The Knee injury and osteoarthritis outcome(KOOS) score change in percentage from baseline and 1 month following adductor canal block \[ Time Frame: Baseline and 1 month following adductor canal block \] KOOS is valid,reliable outcome measure in patients with knee osteoarthritis. usually used following knee surgery.This method is recognised as useful also in other and nonsurgical knee treatment.Shortened version widely used in North America is western Ontario and McMaster Universities Index(WOMAC)

  Baseline ,1 hour,1 month, 3 month and 6 months

Secondary Outcomes (5)

• Maximum voluntary isometric contraction of quadriceps muscle (MVIC)

  Baseline ,1 hour,1 month, 3 month and 6 months

• Timed up to go test (TUG)

  Baseline ,1 hour,1 month, 3 month and 6 months

• Satisfaction of patient

  Baseline ,1 hour,1 month, 3 month and 6 months

• Range of knee motion (ROM)

  Baseline ,1 hour,1 month, 3 month and 6 months

• 30 seconds stand up chair test (30 s SCT)

  Baseline ,1 hour,1 month, 3 month and 6 months

Study Arms (2)

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.

Procedure: Canal adductor blockade

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.

Procedure: Canal adductor pulsed radio-frequency therapy

Interventions

Canal adductor blockade 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.

Canal adductor blockade

Canal adductor pulsed radio-frequency therapy 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.

Pulsed radiofrequency therapy

Eligibility Criteria

• Age: 45 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All participants included in this study were sent by family physicians to our Pain ambulance and all have already been diagnosed with knee osteoarthritis chronic pain. The diagnosis was confirmed by Orthopedist engaged in our study. Anesthesiologist decides if the patient is appropriate for the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (10)

• 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.

  PMID: 20418016 BACKGROUND

• 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.

  PMID: 21463469 BACKGROUND

• 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.

  PMID: 35103237 BACKGROUND

• 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.

  PMID: 27015545 BACKGROUND

• 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.

  PMID: 21558611 BACKGROUND

• 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.

  PMID: 34431329 BACKGROUND

• 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.

  PMID: 33887985 BACKGROUND

• 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.

  PMID: 34554694 BACKGROUND

• 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.

  PMID: 28339430 BACKGROUND

• 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.

  PMID: 21055873 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mensur Salihovic

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mensur Salihovic, MD

CONTACT

+38640208892; mensur.salihovic@kclj.si

Mensur Salihovic

CONTACT

+38640208892; mensur.salihovic@kclj.si

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 27, 2023
• Study Start: October 9, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the end of the study and the publishing results.
• Access Criteria: The request needs to be addressed to the principal investigator. It should come from an official address or from a student or researcher personally.

Locations

SL (1)