Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatme… (NCT02260869) | Clinical Trial Compass
TerminatedNot Applicable
Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain
Stopped: Due to financial constraints, sponsor could not complete the study.
United States79 participantsStarted 2015-01
Plain-language 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.
Who can participate
Age range18 Years – 100 Years
SexALL
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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 opi…