Clinical trial NCT03631030: Cooled RF Lesion MRI Characteristics
Official title: A Prospective, Single-center, Pilot Study of in Vivo Lesion Characteristics Post Coolief Cooled Radiofrequency Denervation as a Treatment for Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthritis;Lumbosacral
Osteo Arthritis Knee
Sacroiliitis
Hip Osteoarthritis
Arthritis, Degenerative
Keywords: Cooled radiofrequency ablation
MRI
Lead sponsor: International Spine, Pain and Performance Center
Sponsor class: OTHER
Collaborators: name: Halyard Health
First posted: 2018-08-15
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, singe group cohort study
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 21 years
2. Able to understand the informed consent form and provide written informed consent and able to complete outcome measures.
3. Must be clinically appropriate candidate to receive CRFA for treatment of chronic pain.
4. Willing and able to receive an MRI

Exclusion Criteria:

1. Unable to receive an MRI (i.e. due to pacemaker or iron-based metal implant).
2. Unable to receive an MRI (i.e. iron-based metal implant).
3. Extremely thin patients and those with minimal subcutaneous tissue thickness that would not accommodate a radiofrequency lesion of up to 14mm in diameter to limit the risk of skin burns.
4. Active joint infection or systemic or localized infection at the needle entry site (subject may be considered for inclusion once infection is resolved.)
5. Subject currently implanted with a pacemaker or defibrillator
6. In the event a pre-treatment MRI is obtained; trauma or injury occurring to the targeted area between the baseline MRI and CRFA treatment
7. Subject unwillingness or unable to comply with protocol requirements

Primary outcomes:
measure: Cooled radiofrequency ablation lesion size
timeFrame: MRI obtained between 2-7 days post-procedure.
Secondary outcomes:
measure: Pain relief
timeFrame: 2-4 weeks post-procedure as compared to pre-procedure
Other outcomes:
Locations:
city: Washington
country: United States
facility: International Spine, and Performance Center
state: District of Columbia
city: Arlington
country: United States
facility: International Spine, Pain and Performance Center
state: Virginia
Study officials:
affiliation: International Spine Pain & Performance Center
name: Mehul Desai, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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