NCT03886142

Brief Summary

Osteoarthritis (OA) affects aged above 45 years. RF has been used for several painful conditions. There have been a few attempts to use RF current for the treatment of painful conditions of joints of the extremities. It was also used for the treatment of painful conditions of the hip joint.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

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

Study Start

First participant enrolled

September 27, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

March 20, 2019

Last Update Submit

January 15, 2020

Conditions

Osteo Arthritis KneePain, Chronic

Outcome Measures

Primary Outcomes (1)

  • pain visual analog scale

    assessment of visual analog scale (VAS) VAS of zero means no pain, and 10 means sever pain

    12 months

Study Arms (2)

radiofrequency

ACTIVE COMPARATOR

genicular nerves pulsed radiofrequency

Procedure: radiofrequency

intra-articular platelet rich plasma

ACTIVE COMPARATOR

injection of platelet rich plasma in the affected joint

Procedure: platelet rich plasma injection

Interventions

radiofrequencyPROCEDURE

radiofrequency of the genicular nerves

radiofrequency
platelet rich plasma injectionPROCEDURE

intra articular injection of platelet rich plasma

intra-articular platelet rich plasma

Eligibility Criteria

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

You may qualify if:

  • osteoarthritis knee

You may not qualify if:

  • coaguloapthy
  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: patients with chronic knee osteoarthritis non res ponders to conventional medical treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 22, 2019

Study Start

September 27, 2018

Primary Completion

October 30, 2019

Study Completion

November 30, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

EG(1)