NCT03224637

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

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

July 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

1.4 years

First QC Date

July 19, 2017

Last Update Submit

July 22, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • pain assessment by VAS scale

    assessing pain by VAS scale

    6 months

Secondary Outcomes (2)

  • patient satisfaction by Likert scale

    6 months

  • patient disability by Western Ontario McMaster Universities OA index

    6 months

Study Arms (2)

radiofrequency group

ACTIVE COMPARATOR

radiofrequency was done in the three genicular nerves upper medial and upper lateral and lower medial

Procedure: radiofrequency

conventional group

ACTIVE COMPARATOR

the patients received conventional paracetamol and non steroidal antiinflammatory

Drug: Paracetamol (conventional)Drug: Ketorolac Tromethamine (conventional)

Interventions

radiofrequency done in the three genicular nerves upper medial and upper lateral and lower medial

radiofrequency group
conventional group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic arthritis according to the American College of Rheumatology criteria
  • diagnosed radiologically patients in stage 3 and 4, according to the Kellgren-Lawrence classification

You may not qualify if:

  • other causes of pain such as radiculopathy, neurological disorders, or intermittent claudication.
  • patients receive intraarticular steroid or hyaluronic acids during previous three months.
  • patients did previous knee surgery.
  • Patients with general contraindication to the application of invasive intervention such as hemorrhage, coagulation disorder, systemic infection or local infection.
  • patients with other connective tissue disease affecting the knee. And 6-psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

Related Publications (1)

  • El-Hakeim EH, Elawamy A, Kamel EZ, Goma SH, Gamal RM, Ghandour AM, Osman AM, Morsy KM. Fluoroscopic Guided Radiofrequency of Genicular Nerves for Pain Alleviation in Chronic Knee Osteoarthritis: A Single-Blind Randomized Controlled Trial. Pain Physician. 2018 Mar;21(2):169-177.

MeSH Terms

Conditions

Chronic Pain

Interventions

AcetaminophenCongresses as TopicKetorolac Tromethamine

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesOrganizationsHealth Care Economics and OrganizationsIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia and ICU

Study Record Dates

First Submitted

July 19, 2017

First Posted

July 21, 2017

Study Start

July 1, 2014

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations