Osteoarthritis, KneeNCT02260869
Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain
A study testing Genicular nerve radiofrequency ablation and Pain Management Radiofrequency Kit in people with Osteoarthritis, Knee, run by Millennium Pain Center at 3 sites in United States.
Trial summary
This is a single center randomized controlled trial. Approximately 102 patients will be randomized to one of two treatment groups: cooled radiofrequency or conventional monopolar radiofrequency ablation. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Genicular nerve radiofrequency ablation and Pain Management Radiofrequency Kit
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2015to 26 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have given their written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the patient's participation is provided to them.
- Female patients who are not pregnant and do not plan to become pregnant during the study. Females of child bearing potential must provide a negative pregnancy test provided by the study physician and must be using reliable contraception and must continue to use reliable contraception until study completion at 52 weeks. Non-childbearing potential is defined as postmenopausal for at least 2 years or surgical sterilization or hysterectomy at least 3 months before study start.
- Must be older than 18 years old..
- Must have chronic knee pain for at least 6 months.
- Must have radiologic evidence of OA of the knee, grade 2-4 based on the Kellgreen-Lawrence scale.
- Persistent pain despite the use of conservative treatment (physical therapy, oral analgesic, steroid injections).
Show all 9Show fewer
- Must have a VAS score of at least 5 with ambulation.
- Subjects must be on a stable dose of pain medication regimen for at least 2 months.
- Greater than or equal to 50% improvement from blocks in target knee for duration of the anesthetic.
Who cannot join
- Knee pain must not be acute.
- Previous total knee replacement.
- Evidence of connective tissue disease.
- Patients who have a BMI greater than 40.
- Evidence of serious neurological or psychiatric disorders.
- Current opioid use must not be greater than or equal to 90 mg morphine equivalent per 24 hour period.
Show all 19Show fewer
- Must not have radicular pain in the affected limb.
- Patients with uncorrected coagulation disorders or who are on anticoagulation therapy and cannot interrupt the therapy.
- Patients who have pacemakers or generators.
- Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests.
- Sexually active female patients of childbearing potential who are not willing to use adequate contraceptive measures to avoid pregnancy until week 52 of the study. Sexually active male patients who are not willing to use adequate contraceptive measures until week 52 of the study. Adequate methods of birth control include the following: Hormonal contraception (female patients) or use of at least one acceptable double-barrier method (for example: diaphragm plus spermicidal agent or condoms (male or female) plus spermicidal agent.), vasectomy, intrauterine device, and/or exclusive sexual partner for whom one of the above acceptable methods applies.
- Patients who have cancer or a past history of any cancer within 5 years prior to the time of informed consent, with the exception of basal cell or squamous cell carcinoma of the skin.
- Human immunodeficiency virus (HIV) infection or a clinically significant infection.
- A clinically significant disorder such as cerebrovascular disease, pulmonary infarction, ischemic heart disease, cardiac dysrhythmia, myocardial infarction, or congestive heart failure.
- Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension.
- Patients who have evidence of major psychiatric disease, mental disorder, drug dependency, alcohol dependency, or substance abuse disorders.
- Any patient with a medical condition and/or disease that the Investigator believes could affect the study results or the safe conduct of the study.
- Patients who are receiving compensation according to Workers' Compensation Act or are involved in personal injury litigation.
- Patients who participated in another clinical study within 3 months prior to the time of informed consent, or who are expected to participate in another study during the period of this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Millennium Pain Center
Bloomington, Illinois, 61704
Millennium Pain Center at Decatur Memorial Hospital
Decatur, Illinois, 62526
Methodist Comprehensive Spine and Pain Center - Millennium Pain Center
Peoria, Illinois, 61602
About this study
Official title: A Prospective Double Blind, Randomized Control Trial to Compare the Efficacy of Cool Radiofrequency Ablation vs. Conventional Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain
This is a single center randomized controlled trial. Approximately 102 patients will be randomized to one of two treatment groups: cooled radiofrequency or conventional monopolar radiofrequency ablation. Patients with chronic knee pain, with moderate to severe osteoarthritis according to the Kellgren-Lawrence scale for at least 6 months who have failed conservative therapy will be screened for the study.
Then, patients will be enrolled based on reporting ≥50% pain relief after a fluoroscopic guided single diagnostic block of the geniculate nerves (superior medial, superior lateral, and inferior medial) with 0.5 ml of local anesthetic (2% Lidocaine).
Read more
Baseline data will be collected for all enrolled patients. Outcomes will be measured at 1, 4, 12, 24 and 52 weeks.
Outcome measures will be: Visual analogue scale (VAS) both while at rest and during ambulation, Oxford knee scores, WOMAC, and global perceived effect.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Genicular nerve radiofrequency ablation, Pain Management Radiofrequency Kit
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular nerve radiofrequency ablationProcedure or surgery
Also called genicular neurotomy using radiofrequency
Radiofrequency ablation uses the electrical field generated by a radiofrequency probe inserted near a nerve responsible for pain. Chronic pain sensation in the knee is generated at the genicular nerves. The physician locates the affected genicular nerve by injecting an anesthetic (lidocaine) that produces a sensory nerve block (i.e. anesthetic pain relief). A radiofrequency probe is inserted percutaneously near the affected nerve using a cannula/introducer and is then connected to a radiofrequency generator. This is set to stimulate sensory and motor response, which allows the physician to adjust the probe position for effective and safe treatment. Then radiofrequency is applied to the tissue for a short time (up to 150 seconds) in order to generate a target temperature (no more than 80 degrees Celsius). The increase in the temperature of the tissue ablates the affected nerve producing pain relief.
Pain Management Radiofrequency KitDevice
The pain management radiofrequency consists of a radiofrequency generator, a radiofrequency probe and an introducer/cannula. The introducer cannula is used to percutaneously position the probe in the appropriate location for treatment. The radiofrequency probe is an electrode that delivers the electric field that heats up the tissue. In cooled radiofrequency the electrode is surrounded by a water jacket that cools it while heat is generated. The generator is the instrument that provides the radiofrequency according to a particular temperature and time program. Temperature, tissue impedance and radiofrequency power are lalso monitored by the generator.
| Study group | Role | What they receive |
|---|---|---|
| Cooled radiofrequency ablation | Active comparator | Patient is placed in supine position on a fluoroscopic table with a pillow under the popliteal fossa. An anterio-posterior fluoroscopic view of the tibio-femoral joint is obtained. Skin and subcutaneous tissues are anesthetized and a 17 g introducer needle is advanced percutaneously towards the junction of shaft with epicondyle until bone contact is made. The needle is then laterally displaced away from the bone. This process is performed at the superior medial and superior lateral aspects of the femur, and the inferior medial aspect of the tibia. The fluoroscope is placed in lateral view to guide the needle depth to be at the medial third of the femur or tibia. A cooled radiofrequency probe from a Pain Management Radiofrequency kit is advanced through the introducer. Following sensory and motor stimulation, cooled genicular nerve radiofrequency ablation is carried out at 60 Celsius for 150 seconds. Receives: Procedure: Genicular nerve radiofrequency ablation; Device: Pain Management Radiofrequency Kit |
| Monopolar radiofrequency ablation | Active comparator | Patient is placed in supine position on a fluoroscopic table with a pillow under the popliteal fossa. An anterio-posterior fluoroscopic view of the tibio-femoral joint is obtained. Skin and subcutaneous tissues are anesthetized and a 16 g introducer needle is advanced percutaneously towards the junction of shaft with epicondyle until bone contact is made. The needle is then laterally displaced away from the bone. This process is performed at the superior medial and superior lateral aspects of the femur, and the inferior medial aspect of the tibia. The fluoroscope is placed in lateral view to guide the needle depth to be at the medial third of the femur or tibia. A conventional radiofrequency probe from a Pain Management Radiofrequency kit is advanced through the introducer. Following sensory and motor stimulation, genicular nerve radiofrequency ablation will be carried out at 80 Celsius for 90 seconds. Receives: Procedure: Genicular nerve radiofrequency ablation; Device: Pain Management Radiofrequency Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Change in Knee Pain
A 100mm visual analog scale (VAS) score at 24 weeks post-treatment will be compared to baseline score to measure change in pain level.
Change in Pain = (VAS at 24 weeks) - (VAS at baseline) The VAS consists of a 100 mm long line without marks between the 0 and 100 mm edges. Range of scale is 0 to 100 mm, where 0 means no pain and 100 mm means the worst pain imaginable.
A negative change in VAS means a reduction in pain level after 24-weeks of treatment.
Measured: 24 weeks
Secondary outcomes (1)
Evidence of Functional Changes
Standard score system (Oxford Knee Score) was used to assess functional changes at 24 weeks of treatment relative to baseline. The Oxford Knee Score (OKS) measures the level of function, activities of daily living and how they have been affected by knee pain. The OKS is a obtained from a 12-item patient reported questionnaire. Each item has 5 categories, scored from 0 to 4, with 0 being the worst outcome and 4 the best outcome of each item. The OKS is the sum of all item scores. Therefore, it ranges from 0 to 48, with 0 being the worst functional outcome possible and 48 is the best functional outcome possible.
Change in OKS = (OKS at 24 weeks) - (OKS at baseline) A positive Change in OKS indicates an improvement in extent of function.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startJan 2015
- Primary completion15 Oct 2018
- Study completion26 Jun 2019
Why it stopped: Due to financial constraints, sponsor could not complete the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pain Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Vallejo, MD, PhD, Principal investigator, Millennium Pain Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260869
- Sponsor's protocol ID
- MPC-2014-GNK
- Status last verified
- Apr 2022
- First submitted
- 6 Oct 2014
- Last updated
- 26 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Murphy L, Helmick CG. The impact of osteoarthritis in the United States: a population-health perspective: A population-based review of the fourth most common cause of hospitalization in U.S. adults. Orthop Nurs. 2012 Mar-Apr;31(2):85-91. doi: 10.1097/NOR.0b013e31824fcd42.
PubMed 22446800Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.
PubMed 17216685Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. doi: 10.1136/ard.60.2.91.
PubMed 11156538Karaman H, Tufek A, Kavak GO, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. Epub 2011 Jul 23.
PubMed 21872812Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
PubMed 21055873Ikeuchi M, Ushida T, Izumi M, Tani T. Percutaneous radiofrequency treatment for refractory anteromedial pain of osteoarthritic knees. Pain Med. 2011 Apr;12(4):546-51. doi: 10.1111/j.1526-4637.2011.01086.x. Epub 2011 Apr 4.
PubMed 21463469Vallejo R, Benyamin R, Tilley DM, Kelley CA, Cedeno DL. An ex vivo comparison of cooled-radiofrequency and bipolar-radiofrequency lesion size and the effect of injected fluids. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):312-21. doi: 10.1097/AAP.0000000000000090.
PubMed 24781285
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double Blind, Randomized Control Trial to Compare the Efficacy of Cool Radiofrequency Ablation vs. Conventional Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain
- ClinicalTrials.gov ID
- NCT02260869
- Acronym / sponsor ID
- MPC-2014-GNK
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to financial constraints, sponsor could not complete the study.
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Millennium Pain CenterUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Posted 26 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center randomized controlled trial. Approximately 102 patients will be randomized to one of two treatment groups: cooled radiofrequency or conventional monopolar radiofrequency ablation. Patients with chronic knee pain, with moderate to severe osteoarthritis according to the Kellgren-Lawrence scale for at least 6 months who have failed conservative therapy will be screened for the study.
Then, patients will be enrolled based on reporting ≥50% pain relief after a fluoroscopic guided single diagnostic block of the geniculate nerves (superior medial, superior lateral, and inferior medial) with 0.5 ml of local anesthetic (2% Lidocaine).
Baseline data will be collected for all enrolled patients. Outcomes will be measured at 1, 4, 12, 24 and 52 weeks.
Outcome measures will be: Visual analogue scale (VAS) both while at rest and during ambulation, Oxford knee scores, WOMAC, and global perceived effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooled radiofrequency ablation | Active comparator | Procedure: Genicular nerve radiofrequency ablation, Device: Pain Management Radiofrequency KitPatient is placed in supine position on a fluoroscopic table with a pillow under the popliteal fossa. An anterio-posterior fluoroscopic view of the tibio-femoral joint is obtained. Skin and subcutaneous tissues are anesthetized and a 17 g introducer needle is advanced percutaneously towards the junction of shaft with epicondyle until bone contact is made. The needle is then laterally displaced away from the bone. This process is performed at the superior medial and superior lateral aspects of the femur, and the inferior medial aspect of the tibia. The fluoroscope is placed in lateral view to guide the needle depth to be at the medial third of the femur or tibia. A cooled radiofrequency probe from a Pain Management Radiofrequency kit is advanced through the introducer. Following sensory and motor stimulation, cooled genicular nerve radiofrequency ablation is carried out at 60 Celsius for 150 seconds. |
| Monopolar radiofrequency ablation | Active comparator | Procedure: Genicular nerve radiofrequency ablation, Device: Pain Management Radiofrequency KitPatient is placed in supine position on a fluoroscopic table with a pillow under the popliteal fossa. An anterio-posterior fluoroscopic view of the tibio-femoral joint is obtained. Skin and subcutaneous tissues are anesthetized and a 16 g introducer needle is advanced percutaneously towards the junction of shaft with epicondyle until bone contact is made. The needle is then laterally displaced away from the bone. This process is performed at the superior medial and superior lateral aspects of the femur, and the inferior medial aspect of the tibia. The fluoroscope is placed in lateral view to guide the needle depth to be at the medial third of the femur or tibia. A conventional radiofrequency probe from a Pain Management Radiofrequency kit is advanced through the introducer. Following sensory and motor stimulation, genicular nerve radiofrequency ablation will be carried out at 80 Celsius for 90 seconds. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who have given their written informed consent to participate in this clinical study based on voluntary agreement after a thorough explanation of the patient's participation is provided to them.
- Female patients who are not pregnant and do not plan to become pregnant during the study. Females of child bearing potential must provide a negative pregnancy test provided by the study physician and must be using reliable contraception and must continue to use reliable contraception until study completion at 52 weeks. Non-childbearing potential is defined as postmenopausal for at least 2 years or surgical sterilization or hysterectomy at least 3 months before study start.
- Must be older than 18 years old..
- Must have chronic knee pain for at least 6 months.
- Must have radiologic evidence of OA of the knee, grade 2-4 based on the Kellgreen-Lawrence scale.
Key exclusion criteria (19 listed)
- Knee pain must not be acute.
- Previous total knee replacement.
- Evidence of connective tissue disease.
- Patients who have a BMI greater than 40.
- Evidence of serious neurological or psychiatric disorders.
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 |
|---|---|---|
| Genicular nerve radiofrequency ablationAlso: genicular neurotomy using radiofrequencyRadiofrequency ablation uses the electrical field generated by a radiofrequency probe inserted near a nerve responsible for pain. Chronic pain sensation in the knee is generated at the genicular nerves. The physician locates the affected genicular nerve by injecting an anesthetic (lidocaine) that produces a sensory nerve block (i.e. anesthetic pain relief). A radiofrequency probe is inserted percutaneously near the affected nerve using a cannula/introducer and is then connected to a radiofrequency generator. This is set to stimulate sensory and motor response, which allows the physician to adjust the probe position for effective and safe treatment. Then radiofrequency is applied to the tissue for a short time (up to 150 seconds) in order to generate a target temperature (no more than 80 degrees Celsius). The increase in the temperature of the tissue ablates the affected nerve producing pain relief. | Procedure or surgery | Cooled radiofrequency ablation, Monopolar radiofrequency ablation |
| Pain Management Radiofrequency KitThe pain management radiofrequency consists of a radiofrequency generator, a radiofrequency probe and an introducer/cannula. The introducer cannula is used to percutaneously position the probe in the appropriate location for treatment. The radiofrequency probe is an electrode that delivers the electric field that heats up the tissue. In cooled radiofrequency the electrode is surrounded by a water jacket that cools it while heat is generated. The generator is the instrument that provides the radiofrequency according to a particular temperature and time program. Temperature, tissue impedance and radiofrequency power are lalso monitored by the generator. | Device | Cooled radiofrequency ablation, Monopolar radiofrequency ablation |
Primary outcome
Evidence of Change in Knee Pain
Time frame: 24 weeks
A 100mm visual analog scale (VAS) score at 24 weeks post-treatment will be compared to baseline score to measure change in pain level. Change in Pain = (VAS at 24 weeks) - (VAS at baseline) The VAS consists of a 100 mm long line without marks between the 0 and 100 mm edges. Range of scale is 0 to 100 mm, where 0 means no pain and 100 mm means the worst pain imaginable. A negative change in VAS means a reduction in pain level after 24-weeks of treatment.
1 secondary outcome
Evidence of Functional Changes
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22446800Murphy L, Helmick CG. The impact of osteoarthritis in the United States: a population-health perspective: A population-based review of the fourth most common cause of hospitalization in U.S. adults. Orthop Nurs. 2012 Mar-Apr;31(2):85-91. doi: 10.1097/NOR.0b013e31824fcd42.
- Background: PubMed 17216685Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.
- Background: PubMed 11156538Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. doi: 10.1136/ard.60.2.91.
- Background: PubMed 21872812Karaman H, Tufek A, Kavak GO, Yildirim ZB, Uysal E, Celik F, Kaya S. Intra-articularly applied pulsed radiofrequency can reduce chronic knee pain in patients with osteoarthritis. J Chin Med Assoc. 2011 Aug;74(8):336-40. doi: 10.1016/j.jcma.2011.06.004. Epub 2011 Jul 23.
- Background: PubMed 21055873Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
- Background: PubMed 21463469Ikeuchi M, Ushida T, Izumi M, Tani T. Percutaneous radiofrequency treatment for refractory anteromedial pain of osteoarthritic knees. Pain Med. 2011 Apr;12(4):546-51. doi: 10.1111/j.1526-4637.2011.01086.x. Epub 2011 Apr 4.
- Background: PubMed 24781285Vallejo R, Benyamin R, Tilley DM, Kelley CA, Cedeno DL. An ex vivo comparison of cooled-radiofrequency and bipolar-radiofrequency lesion size and the effect of injected fluids. Reg Anesth Pain Med. 2014 Jul-Aug;39(4):312-21. doi: 10.1097/AAP.0000000000000090.
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.
Ricardo Vallejo, MD, PhD principal investigator
Millennium Pain Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genicular nerve radiofrequency ablation and Pain Management Radiofrequency Kit in people with Osteoarthritis, Knee, run by Millennium Pain Center at 3 sites in United States.
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 9 inclusion and 19 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: stopped early, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. 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?
Yes. Results are posted in the registry (first posted 26 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evidence of Change in Knee Pain (time frame: 24 weeks). 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 NCT02260869, which also lists 7 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 26 Apr 2022.