Intra Articular Botox Injection in Treatment of Osteoarth... | NCT03891680

Studies
Intra Articular Botox Injection in Treatment of Osteoarthritis

NCT03891680

Sponsor

Assiut University

Status

Completed

Last Update Posted

Dec 29, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Osteoarthritis Knees Both

Interventions

Botox Injectable Product
Radiofrequancy

Countries

Egypt

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

Dec 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

Oct 20, 2019Actual

Primary Completion Date

Mar 30, 2020Actual

Completion Date

May 1, 2020Actual

First Submitted Date

Mar 23, 2019

First Submission Date that Met QC Criteria

Mar 25, 2019

First Posted Date

Mar 27, 2019Actual

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

Dec 25, 2022

Last Update Posted Date

Dec 29, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Compared the short and long term effects sonography guided of intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided

Detailed Description

Compared the short and long term effects of sonography guided intra articular Botox injection to relief pain and improve patients activity of daily living and disability to genicular nerves pulsed radio frequency fluoroscopy guided

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Botox injection	Experimental		Drug: Botox Injectable Product
Genicular Radio frequency	Active Comparator		Device: Radiofrequancy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botox Injectable Product	Drug	Intra articular Botox injection	Botox injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain visual analog scale	0-10 Visual analog scale( less than 3 no pain 3-5 in pain, more than 5 sever pain	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

osteoarthritis

Exclusion Criteria:

coagulopathy Organ failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abdallah Allam	Physical medicine Tanta university	Study Chair
Rasha Gaber	Biochemistry Tanta university	Study Chair
Ke Vin	Taiwan	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Manal Hassanien		Asyut			Egypt