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Clinical Trial Summary

The purpose of this study is to test the efficacy of radiofrequency ablation of the medial branch nerves (RFA-MBN) in relieving pain and improving physical function in patients with subacute and chronic vertebral compression fractures (VCF).


Clinical Trial Description

The study examines a novel approach to treat pain associated with VCFs. The usual care therapy currently involves utilizing physical therapy, non-steroidal anti-inflammatory medications, opioids, and bone re-building medications known as bisphosphonates. A usual treatment plan may include some, if not all the above. There is growing evidence that the posterior spinal elements contribute to pain that patients with VCFs experience. RFA-MBN, which targets these posterior spinal elements, may provide more sustained pain relief and improved physical function compared to usual care for these fractures. The procedure essentially "ablates with heat" the medial branch nerves which send pain signals from the posterior elements to the brain. Patients will be randomly selected into one of two groups. The treatment group will receive the RFA-MBN procedure along with usual care therapy. The control group will undergo usual care. The control group will have the option to cross over to receive RFA-MBN at a defined interval during the study. There will be follow up visits at various intervals to compare pain relief and function based on various surveys of the treatment, control, and cross-over groups. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03651804
Study type Interventional
Source University of California, Davis
Contact
Status Suspended
Phase Phase 4
Start date April 10, 2019
Completion date June 1, 2023

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