NCT05908942

Brief Summary

The aim of this study was to compare the efficacy of phenol and radiofrequency ablation for genicular nerve neurolysis in severe knee pain. The invesigators compare the efficacy of radiofrequency and phenol applications on numerical pain score and Western Ontario and McMaster Universi- ties Osteoarthritis Index (WOMAC) before, 1 and 3 months after the procedure. The procedures will be performed by applying radiofrequency waves and phenol to the genicular nerves under ultrasound guidance.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

June 5, 2023

Last Update Submit

June 16, 2023

Conditions

Knee Pain Chronic

Keywords

Genicular radiofrequencyPhenolPain treatmentOsteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Numeric rating scale (NRS)

    Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity.

    Change from Baseline NRS at 3 months

  • Western Ontario and McMaster Universi- ties Osteoarthritis Index (WOMAC)

    The WOMAC Pain score ranges from 0 to 20 with higher scores equating to greater pain with activities of daily living. The generic pain scale ranges from 0 to 10 for the OAI and 0 to 100 for MOST, with higher scores equating to greater pain

    Change from Baseline WOMAC at 3 months

Study Arms (2)

RF group

32 patients with knee osteoarthritis to undergo radiofrequency treatment of genicular nerves

Device: Nerve ablation

Phenol group

32 patients with knee osteoarthritis to undergo phenol treatment of genicular nerves

Device: Nerve ablation

Interventions

Nerve ablationDEVICE

radiofrequency and phenol ablation of the genicular nerves will be performed

Phenol groupRF group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Genicular nerve radiofrequency and phenol for knee osteoarthritis male and female patients undergoing ablation

You may qualify if:

  • Moderate to severe knee pain due to knee osteoarthritis (0-10 pain of intensity 6 and above on an inter-numeric pain scale)
  • Permanent pain for more than 6 months
  • Grade 3 or 4 in the radiological Kellgren-Lawrence classification having osteoarthritis
  • Pain with conservative methods such as analgesics and physiotherapy treatment failure

You may not qualify if:

  • History of intra-articular knee intervention in the last 6 months
  • Cognitive impairment
  • Hepatic or renal insufficiency
  • Severe psychiatric illness
  • Local or systemic infection
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Diskapi Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AgnosiaOsteoarthritis

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Gevher R Genç Perdecioğlu

    Diskapi TRH

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

June 5, 2023

First Posted

June 18, 2023

Study Start

October 1, 2022

Primary Completion

April 1, 2023

Study Completion

June 30, 2023

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations

TU(2)