The Effect of Therapeutic Methods for Chronic Knee Osteoarthritis Pain
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|ClinicalTrials.gov Identifier: NCT00924677|
Recruitment Status : Completed
First Posted : June 19, 2009
Last Update Posted : June 19, 2009
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Procedure: radiofrequency neurotomy for genicular nerve Procedure: radiofrequency neurotomy sham therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Phase 1 Study of Therapeutic Methods for Chronic Knee Osteoarthritis Pain|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||June 2009|
Sham Comparator: lidocaine
Local injection with lidocaine through the RF cannula without activation of RF generator.
Procedure: radiofrequency neurotomy sham therapy
The placebo (sham) group received the same procedure without activation of the RF generator.
Other Name: radiofrequency neurolysis sham therapy
Active Comparator: lidocaine, radiofrequency current
After lidocaine injection through the RF cannula, the temperature of the electrode tip was raised to 70℃ for 90 seconds by RF generator.
Procedure: radiofrequency neurotomy for genicular nerve
RF cannula was advanced percutaneously towards areas connecting the shaft to epicondyle of femur or tibia. Lidocaine (1 mL of 2%) was injected before activation of the RF generator (NeuroThermTM, Morgan automation LTD, Liss, UK). RF electrode was inserted through RF cannula. The temperature of the electrode tip was raised to 70℃ for 90 seconds by radiofrequency generator.
Other Name: neuroablation or radiofrequency neurolysis
- Visual analogue scale pain scores [ Time Frame: at 12 weeks after the procedure ]
- Oxford knee score [ Time Frame: at 12 weeks after the procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924677
|Korea, Republic of|
|Asan Medical Center, University of Ulsan College of Medicine|
|Seoul, Korea, Republic of, 138-736|
|Study Chair:||Pyong-hwan Park, M.D.||Asan Medical Center|