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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vertebral Compression Fracture, Facet Joint Pain

Intervention / Treatment
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* Procedure: Radiofrequency ablation of the medial branch nerves
* Drug: Non-steroidal anti-inflammatory drugs
* Drug: Bisphosphonates
* Drug: Acetaminophen
* Behavioral: Physical therapy
* Drug: Opioids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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<br>* 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.<br>* Other names: NSAID;Drug: Bisphosphonates<br>* A class of drugs that prevent the loss of bone density and are used to treat osteoporosis and similar diseases.<br>Drug: Acetaminophen<br>* A medicine used to treat pain and fever. It is typically used for mild to moderate pain relief. Commonly known as Tylenol.<br>* Other names: Tylenol;Behavioral: Physical therapy<br>* Physical Therapy.<br>Drug: Opioids<br>* Opioids are narcotics that act on opioid receptors to produce morphine-like effects and medically they are primarily used for pain relief.<br>|
| Active Comparator: Treatment Group<br>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<br>* 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.<br>* Other names: RFA-MBB;Drug: Non-steroidal anti-inflammatory drugs<br>* 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.<br>* Other names: NSAID;Drug: Bisphosphonates<br>* A class of drugs that prevent the loss of bone density and are used to treat osteoporosis and similar diseases.<br>Drug: Acetaminophen<br>* A medicine used to treat pain and fever. It is typically used for mild to moderate pain relief. Commonly known as Tylenol.<br>* Other names: Tylenol;Behavioral: Physical therapy<br>* Physical Therapy.<br>Drug: Opioids<br>* Opioids are narcotics that act on opioid receptors to produce morphine-like effects and medically they are primarily used for pain relief.<br>|
| Active Comparator: Crossover Group<br>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<br>* 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.<br>* Other names: RFA-MBB;Drug: Non-steroidal anti-inflammatory drugs<br>* 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.<br>* Other names: NSAID;Drug: Bisphosphonates<br>* A class of drugs that prevent the loss of bone density and are used to treat osteoporosis and similar diseases.<br>Drug: Acetaminophen<br>* A medicine used to treat pain and fever. It is typically used for mild to moderate pain relief. Commonly known as Tylenol.<br>* Other names: Tylenol;Behavioral: Physical therapy<br>* Physical Therapy.<br>Drug: Opioids<br>* Opioids are narcotics that act on opioid receptors to produce morphine-like effects and medically they are primarily used for pain relief.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale (VAS) of subjective pain at dedicated Time Frames listed below. | 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. | 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. | 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. | 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 |