Summary

for people ages 18-90 (full criteria)
healthy people welcome
at UC Davis
study started
estimated completion
David Copenhaver (ucdavis)

Description

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 osteoporotic vertebral compression fractures (VCF).

Official Title

Radiofrequency Ablation of the Medial Branch Nerve as a Novel Treatment for Posterior Element Pain From Vertebral Compression Fractures

Details

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.

Keywords

Vertebral Compression FractureFacet Joint PainFractures, BoneArthralgiaFractures, CompressionAnalgesics, OpioidAcetaminophenAnti-Inflammatory AgentsDiphosphonatesAnti-Inflammatory Agents, Non-SteroidalRadiofrequency ablation of the medial branch nervesNon-steroidal anti-inflammatory drugsBisphosphonatesPhysical therapyOpioids

Eligibility

You can join if…

Open to people ages 18-90

  • Age of fracture greater than or equal to 6 weeks
  • Single Level Vertebral Compression Fracture
  • Osteoporotic vertebral compression fracture Thoracic-9 to Lumbar-5
  • NRS >6/10
  • Cancer-related pathologic 'compression' not 'end-plate' fracture

You CAN'T join if...

  • Uncorrectable Coagulopathy
  • Multiple Level Vertebral Compression Fractures
  • Surgery within 60 days of presentation
  • Active infection
  • Rheumatologic disease
  • Significant neurologic deficit
  • Chronic low back pain in last year
  • Radicular Pain
  • Cognitive impairment
  • Patients with Ongoing Litigation or Worker's Compensation Cases

Location

  • UC Davis Medical Center accepting new patients
    DavisCalifornia95817United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT03651804
Phase
Phase 4
Study Type
Interventional
Last Updated