Cooled RF Lesion MRI Characteristics
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03631030|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2018
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Arthritis;Lumbosacral Osteo Arthritis Knee Sacroiliitis Hip Osteoarthritis Arthritis, Degenerative||Device: Cooled radiofrequency ablation||Not Applicable|
This study will be a prospective, single-center, pilot study. Adult subjects over the age 21 diagnosed with chronic joint pain (≥ 3 months), scheduled to receive Radiofrequency denervation and meet the selection criteria are eligible to participate in this study. The specific targeted areas of interest in this study will include Cervical facet joints, Thoracic facet joints, Lumbar facet joints, Sacroiliac (SI) region, hip and knee.
The treating physician will follow Standard of Care treatment for all enrolled subjects. As illustrated in Figure 1, the study consists of a screening visit, a treatment visit and a follow up visit. All subjects receiving CRFA will receive an MRI 2 - 7 days after the CRFA procedure. Subjects receiving CRFA of the Sacroiliac Joint will also receive an MRI within 30 days prior to the CRFA procedure. The treating physician may also request an MRI be performed prior to the procedure for subjects receiving CRFA of other targeted areas. The point of enrollment for each subject is the time that they sign the Informed Consent Form.
MRI data will be reviewed by the radiologist on a per patient basis to confirm lesion characteristics. It is anticipated that 3-5 subjects per level will be needed to fully quantify lesion characteristics, however; enrollment will remain flexible for each targeted area based on real time review of MRI data.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, singe group cohort study|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Single-center, Pilot Study of in Vivo Lesion Characteristics Post Coolief Cooled Radiofrequency Denervation as a Treatment for Chronic Pain|
|Actual Study Start Date :||February 25, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Cooled radiofrequency ablation
This is a single arm study. Patients who will be undergoing cooled radiofrequency ablation for the treatment of arthritis in the cervical facet joints, thoracic facet joints, lumbar facet joints, sacroiliac (SI) region, hip and knee.
Device: Cooled radiofrequency ablation
Cooled Radiofrequency ablation (CRFA) is a well-established method for delivering lesions into nervous tissue to accomplish neurotomy procedures
- Cooled radiofrequency ablation lesion size [ Time Frame: MRI obtained between 2-7 days post-procedure. ]Size in millimeters of cooled radiofrequency ablation lesion via MRI
- Pain relief [ Time Frame: 2-4 weeks post-procedure as compared to pre-procedure ]Compare pre-procedure and post-procedure change in pain using the numerical pain rating scale with 0 being no pain and 10 being the worst possible pain.
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): NCT03631030
|United States, District of Columbia|
|International Spine, and Performance Center|
|Washington, District of Columbia, United States, 20037|
|United States, Virginia|
|International Spine, Pain and Performance Center|
|Arlington, Virginia, United States, 22205|
|Principal Investigator:||Mehul Desai, MD, MPH||International Spine Pain & Performance Center|