The Effect of Therapeutic Methods for Chronic Knee Osteoarthritis Pain
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
radiofrequency neurotomy for genicular nerve
radiofrequency neurotomy sham therapy
Sponsored by

About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring genicular nerve, osteoarthritis, knee, neurotomy
Eligibility Criteria
Inclusion Criteria:
- patients with chronic knee pain (i.e., knee pain of moderate intensity or greater on most or all days for ≥ 3 months)
- patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4, evaluated by a radiologist)
Exclusion Criteria:
- acute knee pain
- prior knee surgery
- other connective tissue diseases affecting the knee
- serious neurologic or psychiatric disorders
- injection with steroids or hyaluronic acids during the previous 3 months
- sciatic pain
- anticoagulant medications
- pacemakers
- prior electroacupuncture treatments
Sites / Locations
- Asan Medical Center, University of Ulsan College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
lidocaine
lidocaine, radiofrequency current
Arm Description
Local injection with lidocaine through the RF cannula without activation of RF generator.
After lidocaine injection through the RF cannula, the temperature of the electrode tip was raised to 70℃ for 90 seconds by RF generator.
Outcomes
Primary Outcome Measures
Visual analogue scale pain scores
Secondary Outcome Measures
Oxford knee score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00924677
Brief Title
The Effect of Therapeutic Methods for Chronic Knee Osteoarthritis Pain
Official Title
Phase 1 Study of Therapeutic Methods for Chronic Knee Osteoarthritis Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic osteoarthritis (OA) pain of the knee is not effectively abrogated by the available non-pharmacologic or pharmacologic treatments. Radiofrequency (RF) neurotomy is a therapeutic alternative for chronic pain. Here, the researchers investigate the efficacy of RF neurotomy applied to articular branches (genicular nerves) in treating knee joint pain.
Detailed Description
The knee joint is innervated by articular branches of various nerves (femoral, common peroneal, saphenous, tibial and obturator) (Kennedy et al. 1982; Hirasawa et al. 2000). These articular branches around the knee joint are known as genicular nerves. Several genicular nerves can be easily approached percutaneously under fluoroscopic guidance. In our study, genicular nerves were effectively blocked with local anesthetics under fluoroscopic guidance, leading to a significant reduction in knee pain. Rf neurotomy is based on the theory that cutting the nerve supply to a painful structure may alleviate pain and restore function. we evaluate the efficacy of RF neurotomy in reducing pain and improving function in the elderly with chronic knee OA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
genicular nerve, osteoarthritis, knee, neurotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lidocaine
Arm Type
Sham Comparator
Arm Description
Local injection with lidocaine through the RF cannula without activation of RF generator.
Arm Title
lidocaine, radiofrequency current
Arm Type
Active Comparator
Arm Description
After lidocaine injection through the RF cannula, the temperature of the electrode tip was raised to 70℃ for 90 seconds by RF generator.
Intervention Type
Procedure
Intervention Name(s)
radiofrequency neurotomy for genicular nerve
Other Intervention Name(s)
neuroablation or radiofrequency neurolysis
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
radiofrequency neurotomy sham therapy
Other Intervention Name(s)
radiofrequency neurolysis sham therapy
Intervention Description
The placebo (sham) group received the same procedure without activation of the RF generator.
Primary Outcome Measure Information:
Title
Visual analogue scale pain scores
Time Frame
at 12 weeks after the procedure
Secondary Outcome Measure Information:
Title
Oxford knee score
Time Frame
at 12 weeks after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with chronic knee pain (i.e., knee pain of moderate intensity or greater on most or all days for ≥ 3 months)
patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4, evaluated by a radiologist)
Exclusion Criteria:
acute knee pain
prior knee surgery
other connective tissue diseases affecting the knee
serious neurologic or psychiatric disorders
injection with steroids or hyaluronic acids during the previous 3 months
sciatic pain
anticoagulant medications
pacemakers
prior electroacupuncture treatments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pyong-hwan Park, M.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
6897495
Citation
Kennedy JC, Alexander IJ, Hayes KC. Nerve supply of the human knee and its functional importance. Am J Sports Med. 1982 Nov-Dec;10(6):329-35. doi: 10.1177/036354658201000601.
Results Reference
background
PubMed Identifier
10515020
Citation
van Kleef M, Barendse GA, Kessels A, Voets HM, Weber WE, de Lange S. Randomized trial of radiofrequency lumbar facet denervation for chronic low back pain. Spine (Phila Pa 1976). 1999 Sep 15;24(18):1937-42. doi: 10.1097/00007632-199909150-00013.
Results Reference
result
Learn more about this trial
The Effect of Therapeutic Methods for Chronic Knee Osteoarthritis Pain
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