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

University of California (UC) Davis

Status and phase: Terminated; Phase 4

Conditions: Facet Joint Pain; Vertebral Compression Fracture

Treatments: Drug: Opioids; Behavioral: Physical therapy; Procedure: Radiofrequency ablation of the medial branch nerves; Drug: Bisphosphonates; Drug: Non-steroidal anti-inflammatory drugs; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT03651804

1198963

Details and patient eligibility

About

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).

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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5 participants in 3 patient groups

Control Group

Active Comparator group

Description:

The control group will receive usual care for treatment of vertebral compression fractures, which will consist of but not limited to: physical therapy, opioids, NSAIDs, acetaminophen and bisphosphonates as indicated. They will have the option of crossing over (see "Crossover Group") at twelve weeks.

Treatment:

Drug: Acetaminophen

Drug: Bisphosphonates

Drug: Non-steroidal anti-inflammatory drugs

Behavioral: Physical therapy

Drug: Opioids

Treatment Group

Active Comparator group

Description:

The treatment group will receive usual care for treatment and the treatment procedure comprised of the Medial Branch Block and Radiofrequency Ablation. In cases where a medial branch nerve block has confirmed there is pain relief, a radiofrequency ablation is considered. These patients will continue their usual care therapy as well.

Treatment:

Drug: Acetaminophen

Drug: Bisphosphonates

Drug: Non-steroidal anti-inflammatory drugs

Procedure: Radiofrequency ablation of the medial branch nerves

Behavioral: Physical therapy

Drug: Opioids

Crossover Group

Active Comparator group

Description:

This group will comprise of patients within the control group who after 12 weeks of usual therapy will have the option of crossing over to the treatment group. Once crossed over, their treatment and course and measurements will be identical to that of the treatment group.

Treatment:

Drug: Acetaminophen

Drug: Bisphosphonates

Drug: Non-steroidal anti-inflammatory drugs

Procedure: Radiofrequency ablation of the medial branch nerves

Behavioral: Physical therapy

Drug: Opioids