Back to resultsRadiofrequency Neurotomy In Relieving Chronic Knee Pain
Primary Purpose
Osteo Arthritis Knee, Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
radiofrequency
Paracetamol (conventional)
Ketorolac Tromethamine (conventional)
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee
Eligibility Criteria
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.
Sites / Locations
- Emad Zarief Kamel Said
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
radiofrequency group
conventional group
Arm Description
radiofrequency was done in the three genicular nerves upper medial and upper lateral and lower medial
the patients received conventional paracetamol and non steroidal antiinflammatory
Outcomes
Primary Outcome Measures
pain assessment by VAS scale
assessing pain by VAS scale
Secondary Outcome Measures
patient satisfaction by Likert scale
Likert scale to assess patients satisfaction
patient disability by Western Ontario McMaster Universities OA index
Western Ontario McMaster Universities OA index to assess disability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03224637
Brief Title
Radiofrequency Neurotomy In Relieving Chronic Knee Pain
Official Title
Fluoroscopic Guided Radiofrequency of Genicular Nerves for Pain Alleviation in Chronic Knee Osteoarthritis : A Single-blind Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Pain, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
radiofrequency group
Arm Type
Active Comparator
Arm Description
radiofrequency was done in the three genicular nerves upper medial and upper lateral and lower medial
Arm Title
conventional group
Arm Type
Active Comparator
Arm Description
the patients received conventional paracetamol and non steroidal antiinflammatory
Intervention Type
Procedure
Intervention Name(s)
radiofrequency
Intervention Description
radiofrequency done in the three genicular nerves upper medial and upper lateral and lower medial
Intervention Type
Drug
Intervention Name(s)
Paracetamol (conventional)
Intervention Type
Drug
Intervention Name(s)
Ketorolac Tromethamine (conventional)
Primary Outcome Measure Information:
Title
pain assessment by VAS scale
Description
assessing pain by VAS scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
patient satisfaction by Likert scale
Description
Likert scale to assess patients satisfaction
Time Frame
6 months
Title
patient disability by Western Ontario McMaster Universities OA index
Description
Western Ontario McMaster Universities OA index to assess disability
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29565947
Citation
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.
Results Reference
derived
Learn more about this trial
Radiofrequency Neurotomy In Relieving Chronic Knee Pain
We'll reach out to this number within 24 hrs