An interventional study of Cooled radiofrequency ablation in Arthritis;Lumbosacral, Osteo Arthritis Knee and Sacroiliitis, sponsored by International Spine, Pain and Performance Center. Status unknown at 2 sites in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-07.
Sponsored by International Spine, Pain and Performance Center · Not applicable, Interventional, and Treatment
This Prospective, Single-center, Pilot Study will assist in gaining an understanding of the actual CRFA lesions in an in vivo situation in areas where CRFA is utilized as a standard of care treatment option for the relief of chronic pain (cervical facet joints, thoracic facet joints, lumbar facet joints, Sacroiliac (SI) region, hip and knee).
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.
42 studies on the registry are indexed under Sacroiliitis; 11 are open to participants now.
This study's planned enrollment of 15 is below the median of 48 across 28 interventional studies indexed under Sacroiliitis.
Browse Sacroiliitis studies →International Spine, Pain and Performance Center is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Size in millimeters of cooled radiofrequency ablation lesion via MRI
Time frame: MRI obtained between 2-7 days post-procedure.
Pain relief
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.
Time frame: 2-4 weeks post-procedure as compared to pre-procedure
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Feb 2018 (actual). Primary completion is estimated for Jan 2020, 23 months after the start.
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This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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International Spine, Pain and Performance Center