|Age:||18 to 90 years old|
|Keywords:||radiofrequency ablation, vertebral compression fracture, pain|
|Type:||Procedure study, Phase 4|
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
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.