Pulsed Radiofrequency Therapy vs Canal Adductor Blockade in Knee Osteoarthritis

November 27, 2023 updated by: Mensur Salihovic, University Medical Centre Ljubljana

Comparison of the Effectiveness of Pulsed Radiofrequency Therapy and Canal Adductor Blockade for Chronic Pain and Functioning in Knee Osteoarthritis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre
        • Contact:
        • Sub-Investigator:
          • Boris Rijavec
        • Sub-Investigator:
          • Urska Puh
        • Sub-Investigator:
          • Janez Benedik
        • Sub-Investigator:
          • Peter Poredoš

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Baseline ,1 hour,1 month, 3 month and 6 months
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
Time Frame: Baseline ,1 hour,1 month, 3 month and 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum voluntary isometric contraction of quadriceps muscle (MVIC)
Time Frame: Baseline ,1 hour,1 month, 3 month and 6 months
Maximum voluntary isometric contraction of quadriceps muscle (MVIC) measured by handheld dynamometer ] This method is used to check impact of block on contraction of quadriceps muscle.
Baseline ,1 hour,1 month, 3 month and 6 months
Timed up to go test (TUG)
Time Frame: Baseline ,1 hour,1 month, 3 month and 6 months
Time that patient need to stand up from a standard height armchair,walk 3 meters,go back to the chair and takes a seat.Used to assess a patients balance,risk of falling and global mobility
Baseline ,1 hour,1 month, 3 month and 6 months
Satisfaction of patient
Time Frame: Baseline ,1 hour,1 month, 3 month and 6 months
We determine whether the patient is satisfied with the result of treatment by asking the following question: "what is the least amount of success that the treatment would have to achieve by the end of the study and/or treatment for the patient to conclude that the treatment was worth it and the patient is satisfied?" The patient is asked to describe the minimum goal to be satisfied with the treatment in her own words, such as: "50% reduction in pain, to go to the store without assistance, to use only one cane, to not wake up with pain, to perform regular housekeeping duties at home with minimal breaks, to walk a certain distance, or to play tennis". At the end of the study the patient indicates whether that goal was achieved with a "yes" or "no" answer.
Baseline ,1 hour,1 month, 3 month and 6 months
Range of knee motion (ROM)
Time Frame: Baseline ,1 hour,1 month, 3 month and 6 months
Passive knee joint ROM of extension and flexion was measured in the control and blocked leg in the supine position using a goniometer.
Baseline ,1 hour,1 month, 3 month and 6 months
30 seconds stand up chair test (30 s SCT)
Time Frame: Baseline ,1 hour,1 month, 3 month and 6 months
In the 30 s CST, number of times the participant rises from a chair in 30 s is counted.
Baseline ,1 hour,1 month, 3 month and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Principal Investigator: Mensur Salihovic, University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120-464/2022/6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication will be shared with all other researchers.

IPD Sharing Time Frame

After the end of the study and the publishing results.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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