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

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ClinicalTrials.gov Identifier: NCT03651804
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief 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).

Condition or disease Intervention/treatment Phase
Vertebral Compression Fracture Facet Joint Pain Procedure: Radiofrequency ablation of the medial branch nerves Drug: Non-steroidal anti-inflammatory drugs Drug: Bisphosphonates Drug: Acetaminophen Behavioral: Physical therapy Drug: Opioids Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiofrequency Ablation of the Medial Branch Nerve as a Novel Treatment for Posterior Element Pain From Vertebral Compression Fractures
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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 Name: 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 Name: 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.
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 Name: RFA-MBB

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 Name: 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 Name: 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: 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.
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 Name: RFA-MBB

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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651804


Contacts
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Contact: Jaimish Gwalani, MD 415-672-8991 jgwalani@ucdavis.edu
Contact: Christopher Migdal, BS 415-672-8991 cwmigdal@ucdavis.edu

Locations
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United States, California
UC Davis Medical Center Recruiting
Davis, California, United States, 95817
Contact: Jaimish Gwalani, MD    510-386-7942    jgwalani@ucdavis.edu   
Contact: Christopher Migdal, BS    4156728991    cwmigdal@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: David Copenhaver, MD UC Davis Medical Center, Department of Anesthesiology and Pain Medicine

Publications:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03651804     History of Changes
Other Study ID Numbers: 1198963
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Fractures, Bone
Arthralgia
Fractures, Compression
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Acetaminophen
Anti-Inflammatory Agents
Diphosphonates
Anti-Inflammatory Agents, Non-Steroidal
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Bone Density Conservation Agents
Antirheumatic Agents