- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03224637
Radiofrequency Neurotomy In Relieving Chronic Knee Pain
July 22, 2017 updated by: Emad Zarief , MD, Assiut University
Fluoroscopic Guided Radiofrequency of Genicular Nerves for Pain Alleviation in Chronic Knee Osteoarthritis : A Single-blind Randomized Controlled Trial.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt, 71111
- Emad Zarief Kamel Said
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: radiofrequency group
radiofrequency was done in the three genicular nerves upper medial and upper lateral and lower medial
|
radiofrequency done in the three genicular nerves upper medial and upper lateral and lower medial
|
|
Active Comparator: conventional group
the patients received conventional paracetamol and non steroidal antiinflammatory
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain assessment by VAS scale
Time Frame: 6 months
|
assessing pain by VAS scale
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient satisfaction by Likert scale
Time Frame: 6 months
|
Likert scale to assess patients satisfaction
|
6 months
|
|
patient disability by Western Ontario McMaster Universities OA index
Time Frame: 6 months
|
Western Ontario McMaster Universities OA index to assess disability
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
July 19, 2017
First Submitted That Met QC Criteria
July 19, 2017
First Posted (Actual)
July 21, 2017
Study Record Updates
Last Update Posted (Actual)
July 25, 2017
Last Update Submitted That Met QC Criteria
July 22, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Chronic Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Ketorolac
- Acetaminophen
- Ketorolac Tromethamine
Other Study ID Numbers
- IRB00009913
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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