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Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain

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ClinicalTrials.gov Identifier: NCT02260869
Recruitment Status : Active, not recruiting
First Posted : October 9, 2014
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Millennium Pain Center

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Procedure: Genicular nerve radiofrequency ablation Device: Pain Management Radiofrequency Kit Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Cooled radiofrequency ablation
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.
Procedure: Genicular nerve radiofrequency ablation
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.
Other Name: genicular neurotomy using radiofrequency

Device: Pain Management Radiofrequency Kit
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.

Active Comparator: Monopolar radiofrequency ablation
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.
Procedure: Genicular nerve radiofrequency ablation
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.
Other Name: genicular neurotomy using radiofrequency

Device: Pain Management Radiofrequency Kit
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.




Primary Outcome Measures :
  1. Evidence of reduction in knee pain [ Time Frame: 24 weeks ]
    A pain visual analog score at 24 weeks post-treatment will be compare to baseline score


Secondary Outcome Measures :
  1. Evidence of functional changes [ Time Frame: 24 months ]
    Standard score systems (Oxford and WOMAC) will be used to assess functional changes



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

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): NCT02260869


Locations
United States, Illinois
Millennium Pain Center
Bloomington, Illinois, United States, 61701
Millennium Pain Center at Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Methodist Comprehensive Spine and Pain Center - Millennium Pain Center
Peoria, Illinois, United States, 61602
Sponsors and Collaborators
Millennium Pain Center
Investigators
Principal Investigator: Ricardo Vallejo, MD, PhD Millennium Pain Center

Publications:

Responsible Party: Millennium Pain Center
ClinicalTrials.gov Identifier: NCT02260869     History of Changes
Other Study ID Numbers: MPC-2014-GNK
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases