Efficacy of Genicular Nerve Radiofrequency

Sponsor
Diskapi Teaching and Research Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04100707
Collaborator
(none)
50
1
2
1.5
33.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Genicular block was applied
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Efficacy of Genicular Nerve Radiofrequency in Patients With Knee Pain After Total Knee Replacement
Anticipated Study Start Date :
Sep 20, 2019
Anticipated Primary Completion Date :
Oct 4, 2019
Anticipated Study Completion Date :
Nov 4, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Post intervention analgesic effect [at first 3 months]

    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.

Secondary Outcome Measures

  1. Ultrasound versus fluoroscopy [at first 3 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Diskapi Teaching and Research Hospital Ankara Turkey

Sponsors and Collaborators

  • Diskapi Teaching and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alp ALPTEKIN, University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT04100707
Other Study ID Numbers:
  • diskapi01
First Posted:
Sep 24, 2019
Last Update Posted:
Sep 24, 2019
Last Verified:
Sep 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alp ALPTEKIN, University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital, Diskapi Teaching and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 24, 2019