NCT05528965

Brief Summary

Although there are different ways of performing genicular nerve radiofrequency on knee pain, to our knowledge, there is no stuies comparing the clinical outcomes of a parallel technique vs. a perpendicular technique. We aimed to compare the effectiveness of these both techniques.

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
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

12 months

First QC Date

September 1, 2022

Last Update Submit

April 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS)

    The proportion of patients with a pain reduction of at least 50% compared to baseline expressed by the numerical rating scale (NRS) (0-10).The lower the score, the least pain the patient experiences.

    6 months after intervention.

Secondary Outcomes (1)

  • The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    6 months after intervention.

Study Arms (2)

Perpendicular Group

EXPERIMENTAL

Perpendicular genicular radiofrequency application

Procedure: Perpendicular Group

Parallel Group

ACTIVE COMPARATOR

Parallel genicular radiofrequency application

Procedure: Parallel Group

Interventions

Radiofrequency ablation was applied to the perpendicular group by placing the tip of electrode perpendicularly to contact the genicular nerves.

Perpendicular Group

Radiofrequency ablation was applied to the parallel group by placing the electrode lay parallel to contact the genicular nerves.

Parallel Group

Eligibility Criteria

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

You may not qualify if:

  • Intra-articular injections in the knee during the 3 months prior to procedure
  • Chronic pain syndrome
  • Lumbar radicular pain
  • Patients who are unwilling or mentally incapable to complete the study questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

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

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 6, 2022

Study Start

September 5, 2022

Primary Completion

August 30, 2023

Study Completion

September 15, 2023

Last Updated

April 4, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations