Radiofrequency Ablation: Treatment for Posterior Element Pain From Vertebral Compression Fractures
- Conditions
- Facet Joint PainVertebral Compression Fracture
- Interventions
- Procedure: Radiofrequency ablation of the medial branch nervesDrug: Non-steroidal anti-inflammatory drugsDrug: BisphosphonatesBehavioral: Physical therapyDrug: Opioids
- Registration Number
- NCT03651804
- Lead Sponsor
- 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).
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment Group Non-steroidal anti-inflammatory drugs 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. Control Group Bisphosphonates 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. Control Group Physical therapy 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. Crossover Group Physical therapy 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 Group Physical therapy 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. Control Group Non-steroidal anti-inflammatory drugs 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. Control Group Opioids 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 Group Radiofrequency ablation of the medial branch nerves 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 Group Opioids 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. Crossover Group Radiofrequency ablation of the medial branch nerves 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. Crossover Group Non-steroidal anti-inflammatory drugs 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 Group Bisphosphonates 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. Crossover Group Bisphosphonates 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. Crossover Group Opioids 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. Control Group Acetaminophen 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 Group Acetaminophen 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. Crossover Group Acetaminophen 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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.
Trial Locations
- Locations (1)
UC Davis Medical Center
🇺🇸Davis, California, United States