Cooled RF Lesion MRI Characteristics
Unknown statusNot applicableNCT03631030
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- A Prospective, Single-center, Pilot Study of in Vivo Lesion Characteristics Post Coolief Cooled Radiofrequency Denervation as a Treatment for Chronic Pain
- Conditions
- Arthritis
- Lumbosacral
- Osteo Arthritis Knee
- Sacroiliitis
- Hip Osteoarthritis
- Arthritis, Degenerative
- Interventions
- Device: Cooled radiofrequency ablation
- Sponsor
- International Spine, Pain and Performance Center
- Collaborators
- Halyard Health
- Start date
- 2018-02-25
- Primary completion
- 2020-01
- Sex
- All
- Age range
- from 21 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03631030