UnknownNot Applicable

Cooled RF Lesion MRI Characteristics

United States15 participantsStarted 2018-02-25

Plain-language 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).

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. Unable to receive an MRI (i.e. due to pacemaker or iron-based metal implant).
✕. Unable to receive an MRI (i.e. iron-based metal implant).
✕. 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.
✕. Active joint infection or systemic or localized infection at the needle entry site (subject may be considered for inclusion once infection is resolved.)
✕. Subject currently implanted with a pacemaker or defibrillator
✕. In the event a pre-treatment MRI is obtained; trauma or injury occurring to the targeted area between the baseline MRI and CRFA treatment
✕. Subject unwillingness or unable to comply with protocol requirements

What they're measuring

Cooled radiofrequency ablation lesion size

Timeframe: MRI obtained between 2-7 days post-procedure.

Trial details

NCT IDNCT03631030

SponsorInternational Spine, Pain and Performance Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01

View on ClinicalTrials.gov More Arthritis;Lumbosacral trials