Osteoarthritis, KneeNCT00924677
The Effect of Therapeutic Methods for Chronic Knee Osteoarthritis Pain
A study testing radiofrequency neurotomy for genicular nerve in people with Osteoarthritis, Knee, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- radiofrequency neurotomy for genicular nerve
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- anticoagulant medications
- pacemakers
- prior electroacupuncture treatments
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 138-736
About this study
Official title: Phase 1 Study of Therapeutic Methods for Chronic Knee Osteoarthritis Pain
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- radiofrequency neurotomy for genicular nerve, radiofrequency neurotomy sham therapy
- Keywords
- genicular nerve, osteoarthritis, knee, neurotomy
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency neurotomy for genicular nerveProcedure or surgery
Also called neuroablation or radiofrequency neurolysis
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.
radiofrequency neurotomy sham therapyProcedure or surgery
Also called radiofrequency neurolysis sham therapy
The placebo (sham) group received the same procedure without activation of the RF generator.
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Sham comparator | Local injection with lidocaine through the RF cannula without activation of RF generator. Receives: Procedure: radiofrequency neurotomy sham therapy |
| lidocaine, radiofrequency current | Active comparator | After lidocaine injection through the RF cannula, the temperature of the electrode tip was raised to 70℃ for 90 seconds by RF generator. Receives: Procedure: radiofrequency neurotomy for genicular nerve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale pain scores
Measured: at 12 weeks after the procedure
Secondary outcomes (1)
Oxford knee score
Measured: at 12 weeks after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Pyong-hwan Park, M.D., Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924677
- Sponsor's protocol ID
- GN0901
- Status last verified
- Jun 2009
- First submitted
- 18 Jun 2009
- Last updated
- 19 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 6897495van 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.
PubMed 10515020
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Therapeutic Methods for Chronic Knee Osteoarthritis Pain
- ClinicalTrials.gov ID
- NCT00924677
- Acronym / sponsor ID
- GN0901
- Conditions
- Osteoarthritis, Knee
- Keywords
- genicular nerve, osteoarthritis, knee, neurotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 19 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Sham comparator | Procedure: radiofrequency neurotomy sham therapyLocal injection with lidocaine through the RF cannula without activation of RF generator. |
| lidocaine, radiofrequency current | Active comparator | Procedure: radiofrequency neurotomy for genicular nerveAfter lidocaine injection through the RF cannula, the temperature of the electrode tip was raised to 70℃ for 90 seconds by RF generator. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency neurotomy for genicular nerveAlso: neuroablation or radiofrequency neurolysisRF 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. | Procedure or surgery | lidocaine, radiofrequency current |
| radiofrequency neurotomy sham therapyAlso: radiofrequency neurolysis sham therapyThe placebo (sham) group received the same procedure without activation of the RF generator. | Procedure or surgery | lidocaine |
Primary outcome
Visual analogue scale pain scores
Time frame: at 12 weeks after the procedure
1 secondary outcome
Oxford knee score
Time frame: at 12 weeks after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2009.
- Background: PubMed 6897495Kennedy 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 publication: PubMed 10515020van 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.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pyong-hwan Park, M.D. study chair
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency neurotomy for genicular nerve in people with Osteoarthritis, Knee, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale pain scores (time frame: at 12 weeks after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00924677, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2009.