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Intermedius Genicular Nerve in the Treatment of Patients With Chondromalacia Patella

Primary Purpose

Chondromalacia Patellae

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
radiofrequency
control
2% lidocaine
Sponsored by
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chondromalacia Patellae focused on measuring radiofrequency neurotomy, knee pain, ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Gaziler Physical Medicine and Rehabilitation Education and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

radiofrequency group

control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patello Femoral Pain Intensity Scale
Patello Femoral Pain Intensity Scale to evaluate patients' pain in climbing / descending stairs, squatting, walking, jogging, sprinting, sports, sitting for 20 minutes with knees flexed at 90 °, standing on the knee, resting and resting after an activityStair climbing / descending, crouching, walking, jogging, sprinting, sports, sitting for 20 minutes with knees flexed at 90 °, standing on the knee, resting and resting after an activity, travel 10 cm as standard 0 "no pain" at one end, 10 At the other end it was rated as "excruciating pain" with a total score of 100.

Full Information

First Posted
September 20, 2021
Last Updated
October 26, 2021
Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05096520
Brief Title
Intermedius Genicular Nerve in the Treatment of Patients With Chondromalacia Patella
Official Title
The Efficiency of Radiofrequency Ablation Therapy Applied to the Intermedius Genicular Nerve in the Treatment of Patients With Chondromalacia Patella
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Anticipated)
Study Completion Date
July 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
The study was designed as prospective, randomized, controlled trial. 46 people who met the inclusion criteria were randomized into two groups of 23 people. The first group will be designated as Nerve blockage group and nerve blocking program will be applied to these patients. Patients in the second group will be designated as the Radiofrequency group and radiofrequency ablation after the blockade program will be applied in accordance with the radiofrequency ablation protocol.Participants were evaluated with Visual Analogue Scale (VAS), Patello Femoral Pain Severity Scale (PFPSS), Kuala's Patellofemoral Scoring System (KPSS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chondromalacia Patellae
Keywords
radiofrequency neurotomy, knee pain, ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
radiofrequency group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The intermedius genicular nerve will be found under US guidance and the genicular nerve will be blocked by injecting 1 ml of 2% lidocaine.
Intervention Type
Procedure
Intervention Name(s)
radiofrequency
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
control
Intervention Description
The intermedius genicular nerve will be found under US guidance and the genicular nerve will be blocked by injecting 1 ml of 2% lidocaine.
Intervention Type
Drug
Intervention Name(s)
2% lidocaine
Intervention Description
2% lidocaine
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
Change from Baseline , 4th week 12th week
Secondary Outcome Measure Information:
Title
Patello Femoral Pain Intensity Scale
Description
Patello Femoral Pain Intensity Scale to evaluate patients' pain in climbing / descending stairs, squatting, walking, jogging, sprinting, sports, sitting for 20 minutes with knees flexed at 90 °, standing on the knee, resting and resting after an activityStair climbing / descending, crouching, walking, jogging, sprinting, sports, sitting for 20 minutes with knees flexed at 90 °, standing on the knee, resting and resting after an activity, travel 10 cm as standard 0 "no pain" at one end, 10 At the other end it was rated as "excruciating pain" with a total score of 100.
Time Frame
Change from Baseline, 4th week 12th week
Other Pre-specified Outcome Measures:
Title
Kuala Patellofemoral Scoring System
Description
Kuala Patellofemoral Scoring System was used to determine the functional levels of the patients. Participants were evaluated over a minimum of 0 and a maximum of 100 points
Time Frame
Change from Baseline, 4th week 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burak MD BAYIR, MD
Phone
+903122911511
Email
yunusburakbayir@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Serdar KESİKBURUN, MD
Phone
903122911402
Email
serdarkb@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serdar KESİKBURUN, MD
Organizational Affiliation
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Burak BAYIR, MD
Organizational Affiliation
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Özlem KÖROĞLU, MD
Organizational Affiliation
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Esra ÇELİK KARBANCIOĞLU, MD
Organizational Affiliation
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burak BAYIR, MD
Phone
+903122911511
Email
yunusburakbayir@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intermedius Genicular Nerve in the Treatment of Patients With Chondromalacia Patella

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