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

Sponsor
University of California, Davis (Other)
Overall Status
Suspended
CT.gov ID
NCT03651804
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
37.7
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 10, 2019
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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.

    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

    • 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: 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 Names:
  • 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 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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Visual Analog Scale (VAS) of subjective pain at dedicated Time Frames listed below. [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. [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. [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. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC Davis Medical Center Davis California United States 95817

    Sponsors and Collaborators

    • University of California, Davis

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University of California, Davis
    ClinicalTrials.gov Identifier:
    NCT03651804
    Other Study ID Numbers:
    • 1198963
    First Posted:
    Aug 29, 2018
    Last Update Posted:
    Feb 7, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Arthralgia
    Fractures, Bone
    Fractures, Compression
    Acetaminophen
    Diphosphonates
    Anti-Inflammatory Agents
    Anti-Inflammatory Agents, Non-Steroidal

    Study Results

    No Results Posted as of Feb 7, 2022