NCT03891680

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

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

First Submitted

Initial submission to the registry

March 23, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

October 20, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

March 23, 2019

Last Update Submit

December 25, 2022

Conditions

Osteoarthritis Knees Both

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Botox injection

EXPERIMENTAL
Drug: Botox Injectable Product

Genicular Radio frequency

ACTIVE COMPARATOR
Device: Radiofrequancy

Interventions

Botox Injectable ProductDRUG

Intra articular Botox injection

Botox injection
RadiofrequancyDEVICE

Genicular nerves radiofrequancy

Genicular Radio frequency

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • osteoarthritis

You may not qualify if:

  • coagulopathy Organ failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manal Hassanien

Asyut, Egypt

Location

Study Officials

  • Abdallah Allam

    Physical medicine Tanta university

    STUDY CHAIR

  • Rasha Gaber

    Biochemistry Tanta university

    STUDY CHAIR

  • Ke Vin

    Taiwan

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 23, 2019

First Posted

March 27, 2019

Study Start

October 20, 2019

Primary Completion

March 30, 2020

Study Completion

May 1, 2020

Last Updated

December 29, 2022

Record last verified: 2022-12

Locations

EG(1)