Clinical trial NCT02260869: Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Millennium Pain Center
Sponsor class: OTHER
First posted: 2014-10-09
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Evidence of Change in Knee Pain
timeFrame: 24 weeks
Secondary outcomes:
measure: Evidence of Functional Changes
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Millennium Pain Center
state: Illinois
city: Decatur
country: United States
facility: Millennium Pain Center at Decatur Memorial Hospital
state: Illinois
city: Peoria
country: United States
facility: Methodist Comprehensive Spine and Pain Center - Millennium Pain Center
state: Illinois
Study officials:
affiliation: Millennium Pain Center
name: Ricardo Vallejo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Jordan 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.
citation: Peat 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.
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citation: Choi 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.
citation: Ikeuchi 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.
citation: Vallejo 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.