Cooled RF Lesion MRI Characteristics

NCT03631030 | Unknown DMC FDA Device

• 1 other identifier: 105-17-0004
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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).

Conditions

Arthritis;Lumbosacral; Osteo Arthritis Knee; Sacroiliitis; Hip Osteoarthritis; Arthritis, Degenerative

Keywords

Cooled radiofrequency ablation; MRI

Outcome Measures

Primary Outcomes (1)

• Cooled radiofrequency ablation lesion size

  Size in millimeters of cooled radiofrequency ablation lesion via MRI

  MRI obtained between 2-7 days post-procedure.

Secondary Outcomes (1)

• Pain relief

  2-4 weeks post-procedure as compared to pre-procedure

Study Arms (1)

Cooled radiofrequency ablation

OTHER

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

Interventions

Cooled radiofrequency ablation DEVICE

Cooled Radiofrequency ablation (CRFA) is a well-established method for delivering lesions into nervous tissue to accomplish neurotomy procedures

Cooled radiofrequency ablation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• International Spine, Pain and Performance Center: lead
• Halyard Health: collaborator

Study Sites (2)

International Spine, and Performance Center

Washington D.C., District of Columbia, 20037, United States

Location

International Spine, Pain and Performance Center

Arlington, Virginia, 22205, United States

Location

Related Publications (7)

• Kapural L, Stojanovic M, Sessler DI, Bensitel T, Zovkic P. Cooled radiofrequency (RF) of L5 dorsal ramus for RF denervation of the sacroiliac joint: technical report. Pain Med. 2010 Jan;11(1):53-7. doi: 10.1111/j.1526-4637.2009.00772.x. Epub 2009 Dec 16.

  PMID: 20030745 BACKGROUND

• Patel N, Gross A, Brown L, Gekht G. A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Med. 2012 Mar;13(3):383-98. doi: 10.1111/j.1526-4637.2012.01328.x. Epub 2012 Feb 2.

  PMID: 22299761 BACKGROUND

• Stelzer W, Aiglesberger M, Stelzer D, Stelzer V. Use of cooled radiofrequency lateral branch neurotomy for the treatment of sacroiliac joint-mediated low back pain: a large case series. Pain Med. 2013 Jan;14(1):29-35. doi: 10.1111/pme.12014. Epub 2012 Dec 28.

  PMID: 23279364 BACKGROUND

• Ho KY, Hadi MA, Pasutharnchat K, Tan KH. Cooled radiofrequency denervation for treatment of sacroiliac joint pain: two-year results from 20 cases. J Pain Res. 2013 Jul 4;6:505-11. doi: 10.2147/JPR.S46827. Print 2013.

  PMID: 23869175 BACKGROUND

• Kapural L, Mekhail N. Novel intradiscal biacuplasty (IDB) for the treatment of lumbar discogenic pain. Pain Pract. 2007 Jun;7(2):130-4. doi: 10.1111/j.1533-2500.2007.00120.x.

  PMID: 17559482 BACKGROUND

• Karaman H, Tufek A, Kavak GO, Kaya S, Yildirim ZB, Uysal E, Celik F. 6-month results of TransDiscal Biacuplasty on patients with discogenic low back pain: preliminary findings. Int J Med Sci. 2010 Dec 14;8(1):1-8. doi: 10.7150/ijms.8.1.

  PMID: 21197258 BACKGROUND

• Kapural L, Vrooman B, Sarwar S, Krizanac-Bengez L, Rauck R, Gilmore C, North J, Girgis G, Mekhail N. A randomized, placebo-controlled trial of transdiscal radiofrequency, biacuplasty for treatment of discogenic lower back pain. Pain Med. 2013 Mar;14(3):362-73. doi: 10.1111/pme.12023. Epub 2012 Dec 28.

  PMID: 23279658 BACKGROUND

MeSH Terms

Conditions

Sacroiliitis; Osteoarthritis, Hip; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mehul Desai, MD, MPH

  International Spine Pain & Performance Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, singe group cohort study

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: August 15, 2018
• Study Start: February 25, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)