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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03224637
Other study ID # IRB00009913
Secondary ID
Status Completed
Phase N/A
First received July 19, 2017
Last updated July 22, 2017
Start date July 2014
Est. completion date February 2016

Study information

Verified date July 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Osteoarthritis (OA) is commonest chronic arthritis affecting patients usually aged above 45 years. OA decreased health-related quality of life and increased economic costs. Radiofrequency (RF), was used for the treatment of chronic pain unresponsive to conservative therapies. 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

- chronic arthritis according to the American College of Rheumatology criteria

- diagnosed radiologically patients in stage 3 and 4, according to the Kellgren-Lawrence classification

Exclusion Criteria:

- 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.

Study Design


Intervention

Procedure:
radiofrequency
radiofrequency done in the three genicular nerves upper medial and upper lateral and lower medial
Drug:
Paracetamol (conventional)

Ketorolac Tromethamine (conventional)


Locations

Country Name City State
Egypt Emad Zarief Kamel Said Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain assessment by VAS scale assessing pain by VAS scale 6 months
Secondary patient satisfaction by Likert scale Likert scale to assess patients satisfaction 6 months
Secondary patient disability by Western Ontario McMaster Universities OA index Western Ontario McMaster Universities OA index to assess disability 6 months
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