Radiofrequency Ablation (heat therapy to reduce nerve pain) For Vertebral Compression Fracture Pain

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Age: 18 to 90 years old
Gender:
Any
Healthy Volunteers: No
Keywords: radiofrequency ablation, vertebral compression fracture, pain
Type: Procedure study, Phase 4
Target:
60 Participants
Investigator:
Description
This study hopes to learn if radiofrequency ablation can help relieve pain.

Radiofrequency ablation (or RFA) is a procedure used to reduce pain. An electrical current produced by a radio wave heats up a small area of nerve tissue. This results in decreased pain signals from that specific area.

The treatment will be studied in patients with vertebral compression fractures.
This study requires

You will be randomly selected into one of two groups.

The first group will receive the medial branch block (MBB) followed by radiofrequency ablation (RFA) if the MBB is effective.

The second group will undergo usual care for twelve weeks, and will then have the option to undergo MBB+RFA.

After the MBB+RFA procedure, you will have three follow-up appointments at one week, twelve weeks, and six months, during which you will complete surveys pertaining to the study.

You will receive drugs that are currently used to treat pain associated with vertebral compression fractures, namely, NSAIDs and Acetaminophen. Opioids may be prescribed if indicated.

  • You will have follow-up visits at one week, twelve weeks, and six months after the radiofrequency ablation. If you are in the “crossover” group, you will have follow-up visits at one week and twelve weeks after this appointment

  • The MBB injection takes only a few minutes, although you should set aside about an hour for the whole procedure. The subsequent RFA takes roughly 30-60 minutes although you should set aside about two hours for the while procedure. Each of the four follow-up visit will take roughly 30 minutes.

  • You will interact with your treating physicians and nurses, as well as other research staff of medical students and research coordinators.

  • All research activities will take place at The UC Davis Pain Management Clinic

  • Research will be done during normal business hours

  • There are no experimental treatments or therapies involved in this study. We are trying to understand if the widely-used therapy of MBB+RFA can be used to relieve pain associated with VCFs.

  • There are only two potential procedures that will be performed. First, a medial branch block will be performed. Depending on your response to that procedure, an RFA will be performed less than one week later.

  • MBB+RFA is the procedure being performed as a part of this research study.

  • Pain management with NSAIDs, acetaminophen, physical therapy, and opiates as indicated are performed as usual care even if you do not take part in this research.

  • You may be contacted for future research if you wish

The treatment you get will be chosen by chance, like flipping a coin. Neither you nor the study doctor will choose what treatment you get. You will have an equal chance of being given each treatment. If you are chosen for the usual care group, you will have the option to receive an MBB+RFA after twelve weeks

Who can participate

Inclusion criteria:

  • Age of fracture greater than or equal to 6 weeks
  • Single Level Vertebral Compression Fracture
  • Osteoporotic vertebral compression fracture Thoracic-5 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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
6-9 months
Recruitment period
From June 25, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Jaimish Gwalani
Research Topic
Conditions:
  • Vertebral Compression Fracture
  • Facet Joint Pain

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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