Intermedius Genicular Nerve in the Treatment of Patients With Chondromalacia Patella

NCT05096520 | Unknown

• 1 other identifier: 19
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Radiofrequency application is a treatment method that temporarily prevents the transmission of pain in the nerve where the application is made through the heat emitted by radio waves.Partial inhibition of the functions of the nerves carrying the joint pain sensation with this method is the basis of the treatment.The intermedius genicular nerve carries the sensation of subpatellar pain due to chondromalacia.In this study,investigators aim is to investigate the effect of radiofrequency neurotomy applied to the intermedius genicular nerve, which receives the sensation of the patella, on pain and knee function in patients with a diagnosis of chondromalacia patella who have anterior knee pain that does not resolve despite conservative treatment, under the guidance of ultrasonography.

Conditions

Chondromalacia Patellae

Keywords

radiofrequency neurotomy; knee pain; ultrasound

Outcome Measures

Primary Outcomes (1)

• Knee Pain Severity of pain was assessed using the standard 10 cm VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end initial, 4th week 7th week 24th week pain change

  Severity of pain was assessed using the standard 10 cm VAS with 0 meant "no pain" at one end, and 10 meant "unbearable pain" at the other end

  Change from Baseline , 4th week 12th week

Secondary Outcomes (1)

• Patello Femoral Pain Intensity Scale

  Change from Baseline, 4th week 12th week

Other Outcomes (1)

• Kuala Patellofemoral Scoring System

  Change from Baseline, 4th week 12th week

Study Arms (2)

radiofrequency group

ACTIVE COMPARATOR

the radiofrequency needle will be advanced percutaneously towards the intermedius genicular nerve on the periosteum of the distal femoral shaft region until bone contact is achieved. In addition to imaging the nerve with ultrasound, sensory stimulation at 50 Hz frequency will be applied with a threshold value less than 0.6 V in order to determine its position more accurately. In order to prevent the inactivation of the motor nerves, the relevant nerve will be tested for the absence of fasciculation in the region of the lower extremity compatible with the application with the stimulation with a frequency of 2.0 V and 2 Hz. Before the activation of the radiofrequency generator, an injection of 1 ml of 2% lidocaine will be made, then the radiofrequency electrode will be added to the needle and the temperature level at the tip of the electrode will be increased to 80 degrees for 2 minutes, the procedure will be performed for each genicular nerve.

Procedure: radiofrequency; Drug: 2% lidocaine

control group

ACTIVE COMPARATOR

The intermedius genicular nerve will be found under US guidance and the genicular nerve will be blocked by injecting 1 ml of 2% lidocaine.

Procedure: control; Drug: 2% lidocaine

Interventions

radiofrequency PROCEDURE

the radiofrequency needle will be advanced percutaneously towards the intermedius genicular nerve on the periosteum of the distal femoral shaft region until bone contact is achieved. In addition to imaging the nerve with ultrasound, sensory stimulation at 50 Hz frequency will be applied with a threshold value less than 0.6 V in order to determine its position more accurately. In order to prevent the inactivation of the motor nerves, the relevant nerve will be tested for the absence of fasciculation in the region of the lower extremity compatible with the application with the stimulation with a frequency of 2.0 V and 2 Hz. Before the activation of the Baylis brand radiofrequency generator, an injection of 1 ml of 2% lidocaine will be made, then the radiofrequency electrode will be added to the needle and the temperature level at the tip of the electrode will be increased to 80 degrees for 2 minutes, the procedure will be performed for each genicular nerve.

radiofrequency group

control PROCEDURE

The intermedius genicular nerve will be found under US guidance and the genicular nerve will be blocked by injecting 1 ml of 2% lidocaine.

control group

2% lidocaine DRUG

2% lidocaine

control group; radiofrequency group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female aged \>18 years
• Diagnosis of chondromalacia patella after physical examination and MR imaging
• Those whose symptoms persist for \>3 months
• Participating in the study voluntarily

You may not qualify if:

• Pregnant patients
• History of previous knee surgery
• To have received physical therapy from the knee area in the last 6 months
• Previous RF treatment or any therapeutic injection of the knee such as steroid, hyaluronic acid within 3 months
• Those with pain radiating from the waist or hip
• Patients with neuropathic pain
• History of tumor, infectious, psychiatric disease, bleeding diathesis
• History of knee trauma in the last 6 months
• Those with systemic diseases such as hepatitis, coagulopathy
• Patients with BMI \>40
• Finding a leg length difference

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Chondromalacia Patellae

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Serdar KESİKBURUN, MD

  SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  STUDY DIRECTOR

• Burak BAYIR, MD

  SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  PRINCIPAL INVESTIGATOR

• Özlem KÖROĞLU, MD

  SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  PRINCIPAL INVESTIGATOR

• Esra ÇELİK KARBANCIOĞLU, MD

  SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Burak MD BAYIR, MD

CONTACT

+903122911511; yunusburakbayir@gmail.com

Serdar KESİKBURUN, MD

CONTACT

903122911402; serdarkb@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Medicine and Rehabilitation Specialist

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 27, 2021
• Study Start: May 15, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)