Efficacy of Genicular Nerve Radiofrequency

Efficacy of Genicular Nerve Radiofrequency in Patients With Knee Pain After Total Knee Replacement

In patients with knee pain, local anesthetics and radiofrequency applications to superolateral, superomedial and inferomedial genicular nerves that innervate the knee joint are also preferred methods besides analgesic and physical therapy. When necessary, total knee replacement is the preferred method for primary knee arthrosis.

However, continuing knee pain is reported in approximately 20% of patients after total knee replacement. In similar cases; In the painful knees, the blockages of the genicular nerves are successfully applied.

In this study; the efficacy of imaging-guided radiofrequency application will be investigated in patients presenting with knee pain after total knee replacement.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain
• Intervention / Treatment: Procedure: Genicular block was applied

Detailed Description

Although simple analgesic and physical therapy methods are applied, some patients suffer from pain. Genicular nerve blocks and radiofrequency methods are performed usually for this reason. This procedure is performed with ultrasound and / or fluoroscopy, sterile staining and covering of painful knee to the middle of thigh and leg, localization of superomedial, superolateral, inferomedial genicular nerves are tested and then conventional radiofrequency is applied to all 3 nerve regions.Fifty patients who had total knee prosthesis for gonarthrosis in the Orthopedics and Traumatology Clinic at least 3 months postoperatively had knee pain (infection, mechanical causes and radicular pain) were included in the study.The VAS and WOMAC values recorded at the time of application and the VAS and WOMAC values recorded at the 1st week, 1st month and 3rd month after the procedure will be used to evaluate the effectiveness of the method.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alp ALPTEKIN; Phone Number: +905322659406; Email: alptekinmd@yahoo.com

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Diskapi Teaching and Research Hospital
    • Contact: Alp Alptekin, MD; Phone Number: +90 312 5962370; Email: alptekinmd@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• knee pain

Exclusion Criteria:

• with communication problems (VAS and WOMAC scores could not be evaluated)
• infectious-mechanical pain-related conditions,
• with radicular pain

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Operated; Genicular block will aply to the patients with knee pain who was operated before	Procedure: Genicular block was applied; This procedure is performed with ultrasound and / or fluoroscopy, sterile staining and covering of painful knee to the middle of thigh and leg, localization of superomedial, superolateral, inferomedial genicular nerves are tested and then conventional radiofrequency is applied to all 3 nerve regions
Sham Comparator: Nonoperated; Genicular block will aply to the patients with knee pain who wasn't operated before	Procedure: Genicular block was applied; This procedure is performed with ultrasound and / or fluoroscopy, sterile staining and covering of painful knee to the middle of thigh and leg, localization of superomedial, superolateral, inferomedial genicular nerves are tested and then conventional radiofrequency is applied to all 3 nerve regions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post intervention analgesic effect	Post intervention analgesic effects of genicular block on patients will be recorded. Postoperative pain, digital evaluation scale (Visual analogue scale -VAS; 0= absence of pain, 100= unbearable pain) of all patients will be performed and recorded.	at first 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound versus fluoroscopy	Western Ontario and Mc Masters Osteoarthritis index (VOMAC) will be used to evaluate functional status on the efficacy of Ultrasound and fluoroscopy use.VOMAC is a disease-specific score in which pain, stiffness and physical functions are evaluated. It consists of 24 questions, 5 of which are pain, 2 are stiffness and 17 are evaluating physical function. It has both total score and subgroups can be evaluated separately. Maximum scores were 20 for pain subgroup, 8 for stiffness and 68 for physical function. High scores indicate that the patient has poor values in that group.	at first 3 months

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2019
• Primary Completion (Anticipated): October 4, 2019
• Study Completion (Anticipated): November 4, 2019

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Ultrasound; Knee pain; Genicular nerve
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: diskapi01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No