NCT05073887

Brief Summary

comparison of effectiveness of ultrasound guided genicular nerve blockades and radio frequency stimulation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 10, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

September 29, 2021

Last Update Submit

April 15, 2022

Conditions

Knee Pain Chronic

Keywords

OsteoarthritisRadiofrequencyUltrasoundAnatomical landmarks

Outcome Measures

Primary Outcomes (1)

  • Numerical Rating Scale

    Pain will be evaluated with a Numerical Rating Scale (NRS) score of 0-10 (0= no pain and 10= worst imaginable pain)

    Post injection sixth month

Study Arms (2)

3 nerve

EXPERIMENTAL

3 genicular nerve blockade and radio frequency ablation

Procedure: Current Targets

5 nerve

ACTIVE COMPARATOR

3 genicular nerve blockade and radio frequency ablation 2 genicular nerve blockade and pulse radio frequency

Procedure: Current Targets

Interventions

Current TargetsPROCEDURE

blockade and radio frequency stimulation of genicular nerves

Also known as: Revised Targets
3 nerve5 nerve

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Coagulation disorders
  • Rheumatoid disorders
  • Infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (1)

  • Guven Kose S, Kirac Unal Z, Kose HC, Celikel F, Akkaya OT. Ultrasound-guided genicular nerve radiofrequency treatment: prospective randomized comparative trial of a 3-nerve protocol versus a 5-nerve protocol. Pain Med. 2023 Jul 5;24(7):758-767. doi: 10.1093/pm/pnad025.

    PMID: 36869680DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Selin Guven Kose

    Diskapi Yildirim Beyazit Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 12, 2021

Study Start

March 10, 2021

Primary Completion

December 10, 2021

Study Completion

December 20, 2021

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)