Lateral Epicondylitis Continuous Radiofrequency Microteno... | NCT06116175

Studies
Lateral Epicondylitis Continuous Radiofrequency Microtenotomy

NCT06116175

Sponsor

Iraqi Board of medical specialties

Status

Completed

Last Update Posted

Oct 15, 2024Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Tennis Elbow

Interventions

60 degree thermal radiofequency of tennis elbow

Countries

Iraq

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

Nov 2023

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, 2023Actual

Primary Completion Date

Jun 1, 2024Actual

Completion Date

Aug 1, 2024Actual

First Submitted Date

Oct 30, 2023

First Submission Date that Met QC Criteria

Oct 30, 2023

First Posted Date

Nov 3, 2023Actual

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

Oct 11, 2024

Last Update Posted Date

Oct 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

prospective study measuring the outcome of continuous radio frequency 60 degree on lateral epicondylitis not responding to traditional ultrasound guided injection

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lateral epicondylitis	Experimental	chronic patients of tennis elbow	Procedure: 60 degree thermal radiofequency of tennis elbow

Interventions

Name	Type	Description	Arm Group Labels	Other Names
60 degree thermal radiofequency of tennis elbow	Procedure	under strict aseptic technique ultrasound guided TRF of lateral epicondylitis advanced for 5 mm active tip canula	lateral epicondylitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
decrease in pain score after CRF	decrease in numerical analogue score	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

chronic tennis elbow no response to traditional injection ultrasound exam reveal swelling of common extensor tendon

Exclusion Criteria:

complete tear of common extensor tendon implanted pace maker

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baghdad Medical City		Baghdad		10001	Iraq

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

prospective study measuring the outcome of CRF in tennis elbow

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013716	Tennis Elbow

Ancestor Terms

ID	Term
D000070639	Elbow Tendinopathy
D052256	Tendinopathy
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided