NCT03651804

Radiofrequency Ablation: Treatment for Posterior Element Pain From Vertebral Compression Fractures

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vertebral Compression Fracture
• Facet Joint Pain

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency ablation of the medial branch nerves	A radiofrequency ablation (RFA) is a procedure in which a heat lesion via a needle is created on the nerve that transmits the pain signal in order to interrupt the brain to interrupt the painful signal to the brain. We will target the medial branch nerves.
DRUG	Non-steroidal anti-inflammatory drugs	Some of the most commonly used pain medicines in adults. NSAIDs block proteins, called enzymes, in the body that play a role in pain and inflammation. They include aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and many other generic and brand name drugs.
DRUG	Bisphosphonates	A class of drugs that prevent the loss of bone density and are used to treat osteoporosis and similar diseases.
DRUG	Acetaminophen	A medicine used to treat pain and fever. It is typically used for mild to moderate pain relief. Commonly known as Tylenol.
BEHAVIORAL	Physical therapy	Physical Therapy.
DRUG	Opioids	Opioids are narcotics that act on opioid receptors to produce morphine-like effects and medically they are primarily used for pain relief.

Timeline

• Start date: 2019-04-10
• Primary completion: 2023-12-19
• Completion: 2023-12-19
• First posted: 2018-08-29
• Last updated: 2025-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study