Clinical trial NCT05096520: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chondromalacia Patellae
Keywords: radiofrequency neurotomy
knee pain
ultrasound
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: 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
timeFrame: Change from Baseline , 4th week 12th week
Secondary outcomes:
measure: Patello Femoral Pain Intensity Scale
timeFrame: Change from Baseline, 4th week 12th week
Other outcomes:
measure: Kuala Patellofemoral Scoring System
timeFrame: Change from Baseline, 4th week 12th week
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
affiliation: SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Serdar KESİKBURUN, MD
role: STUDY_DIRECTOR
affiliation: SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Burak BAYIR, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Özlem KÖROĞLU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Esra ÇELİK KARBANCIOĞLU, MD
role: PRINCIPAL_INVESTIGATOR
References: