Radiofrequency Ablation: Treatment for Posterior Element Pain From Vertebral Compression Fractures
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic, Orthopedic, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 3/3/2019 |
| Start Date: | September 1, 2019 |
| End Date: | March 1, 2020 |
| Contact: | Jaimish Gwalani, MD |
| Email: | jgwalani@ucdavis.edu |
| Phone: | 510-386-7942 |
Radiofrequency Ablation of the Medial Branch Nerve as a Novel Treatment for Posterior Element Pain From Vertebral Compression Fractures
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).
branch nerves (RFA-MBN) in relieving pain and improving physical function in patients with
subacute and chronic osteoporotic vertebral compression fractures (VCF).
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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