Predictive Values for the Outcome of Genicular Nerve Radi... | NCT05222776

Studies
Predictive Values for the Outcome of Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain

NCT05222776

Sponsor

Diskapi Teaching and Research Hospital

Status

Completed

Last Update Posted

Mar 2, 2022Actual

Enrollment

206Actual

Phase

Not provided

Conditions

Osteoarthritis, Knee

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2021Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Feb 1, 2022Actual

First Submitted Date

Jan 24, 2022

First Submission Date that Met QC Criteria

Jan 24, 2022

First Posted Date

Feb 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2022

Last Update Posted Date

Mar 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Selin Guven Kose, Principal Investigator, Diskapi Teaching and Research HospitalPrincipal Investigator

Lead Sponsor

Diskapi Teaching and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Researchers are trying to assess a predictive value or correlation between patient and procedural characteristics and outcome measures results after genicular nerve radiofrequency ablation.

Detailed Description

Genicular nerve radiofrequency stimulation procedure is an effective treatment for patients with chronic pain due to knee osteoarthritis; however, little is known about factors that predict procedure success. This study evaluated correlation between patient characteristics and procedural characteristics and pain improvement after ultrasound guided genicular nerve radiofrequency stimulation procedure.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

206Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain assessed by NRS	A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain.	Change from baseline pain score at 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient's 18 years or older
Patients who recently underwent ultrasound guided genicular nerve radiofrequency (RF) procedure

Exclusion Criteria:

lack of documentation of predictive factors to assess outcome
Patients in whom adequate follow-up data was not available
Patients who were prescribed a new analgesic drug or received concurrent treatments for different pain sources during the follow-up period, that could affect interpretation of genicular RF treatment results.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent US guided radiofrequency procedures of the genicular nerves for chronic knee pain

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
selin guven kose, MD	Diskapi Yildirim Beyazit Education and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Diskapi Yildirim Beyazit Training and Research Hospital		Ankara		06110	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided