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

December 16, 2022 updated by: University of California, Davis

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

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).

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95817
        • UC Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
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.
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.
Other Names:
  • NSAID
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.
Other Names:
  • 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.
Active Comparator: Treatment Group
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.
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.
Other Names:
  • NSAID
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.
Other Names:
  • 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.
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.
Other Names:
  • RFA-MBB
Active Comparator: Crossover Group
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.
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.
Other Names:
  • NSAID
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.
Other Names:
  • 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.
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.
Other Names:
  • RFA-MBB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analog Scale (VAS) of subjective pain at dedicated Time Frames listed below.
Time Frame: 0 weeks, 1 week, 12 weeks, 6 months

VAS pain scale (0-10 scale): Overall, at rest, and in bed at night

The VAS Pain scale is a measure of pain intensity. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).

Subjects will report their pain prior to the procedure and at dedicated intervals after to assess change in pain intensity they experience.
0 weeks, 1 week, 12 weeks, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Roland-Morris Disability Questionnaire at dedicated time frames listed below to assess change.
Time Frame: 0 weeks, 1 week, 12 weeks, 6 months
The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain. It is a series of 24 questions in which a "Yes" response appoints one point. A total score of is 24 possible. Clinical improvement over time can be graded based on the analysis of serial questionnaire scores. If, for example, at the beginningof treatment, a patient's score was 12 and, at the conclusion of treatment, her score was 2 (10 points of improvement), we would calculate an 83% (10/12 x 100) improvement.
0 weeks, 1 week, 12 weeks, 6 months
QUALEFFO-41 (Quality of Life questionnaire) Scale at dedicated time frames listed below to assess change.
Time Frame: 0 weeks, 1 week, 12 weeks, 6 months
The Qualeffo-41 is a specific quality of life instrument, which is developed for patients with vertebral compression fractures. This questionnaire comprised of 41 questions, covers main aspects of quality of life: pain, physical functions, social functions, general health and mental health. All answers are standardized so that 1 represents the best and 5 (or 3, or 4) represents the worst quality of life (reverse scores on questions 33, 34, 35, 37, 39, 40). The total score is calculated by summing all answers of questions 1-41. The raw total score ranges from 41 to 205 (or less when some answers are missing) and this is transformed to scores from 0 to 100. The higher the score the poorer the quality of life.
0 weeks, 1 week, 12 weeks, 6 months
Patient Health Questionnaire (PHQ-9) at dedicated Time Frames listed below.
Time Frame: 0 weeks, 1 week, 12 weeks, 6 months
The PHQ-9 is a multipurpose instrument for monitoring and measuring the severity of depression. The PHQ-9 incorporates leading major depressive symptoms into a brief self-report tool. It is comprised of a series of 9 questions that assess a series of feelings/symptoms related to clinical depression over the past two weeks and are graded on a scale of 0-3 (gradation of not at all 0 to every day 3). The scores are tallied up for a total score of 0 to 27. The higher the score the greater the severity of the depression.
0 weeks, 1 week, 12 weeks, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: David Copenhaver, MD, UC Davis Medical Center, Department of Anesthesiology and Pain Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2019

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

August 27, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 16, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1198963

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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