Clinical trial NCT03651804: Radiofrequency Ablation: Treatment for Posterior Element Pain From Vertebral Compression Fractures
Official title: Radiofrequency Ablation of the Medial Branch Nerve as a Novel Treatment for Posterior Element Pain From Vertebral Compression Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Vertebral Compression Fracture
Facet Joint Pain
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: I• Inclusion

* 18-90 years old
* Male or female
* Age of fracture greater than or equal to 6 weeks
* Single Level Vertebral Compression Fracture
* Vertebral compression fracture Thoraic-9 to Lumbar-5
* NRS \>6/10

  • Exclusion
* \<18 or \>90 yo
* Uncorrectable Coagulopathy
* Multiple Level Vertebral Compression Fractures
* Surgery within 60 days of presentation
* Active infection
* Rhuematologic disease
* Significant neurologic deficit
* Radicular pain
* Chronic low back pain in last year
* Inability to give consent
* Cognitive impairment
* Patients with Ongoing Litigation or Worker's Compensation Cases

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) of subjective pain at dedicated Time Frames listed below.
timeFrame: 0 weeks, 1 week, 12 weeks, 6 months
Secondary outcomes:
measure: Roland-Morris Disability Questionnaire at dedicated time frames listed below to assess change.
timeFrame: 0 weeks, 1 week, 12 weeks, 6 months
measure: QUALEFFO-41 (Quality of Life questionnaire) Scale at dedicated time frames listed below to assess change.
timeFrame: 0 weeks, 1 week, 12 weeks, 6 months
measure: Patient Health Questionnaire (PHQ-9) at dedicated Time Frames listed below.
timeFrame: 0 weeks, 1 week, 12 weeks, 6 months
Other outcomes:
Locations:
city: Davis
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
affiliation: UC Davis Medical Center, Department of Anesthesiology and Pain Medicine
name: David Copenhaver, MD
role: PRINCIPAL_INVESTIGATOR
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