Radiofrequency Ablation of the Medial Branch Nerve as a Novel Treatment for Posterior Element Pain From Vertebral Compression Fractures
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Scale (VAS) of subjective pain at dedicated Time Frames listed below.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Non-steroidal anti-inflammatory drugs (Drug)
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.
干预措施: Bisphosphonates (Drug)
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.
干预措施: Acetaminophen (Drug)
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.
干预措施: Physical therapy (Behavioral)
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.
干预措施: Opioids (Drug)
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.
干预措施: Radiofrequency ablation of the medial branch nerves (Procedure)
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.
干预措施: Non-steroidal anti-inflammatory drugs (Drug)
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.
干预措施: Bisphosphonates (Drug)
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.
干预措施: Acetaminophen (Drug)
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.
干预措施: Physical therapy (Behavioral)
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.
干预措施: Opioids (Drug)
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.
干预措施: Radiofrequency ablation of the medial branch nerves (Procedure)
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.
干预措施: Non-steroidal anti-inflammatory drugs (Drug)
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.
干预措施: Bisphosphonates (Drug)
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.
干预措施: Acetaminophen (Drug)
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.
干预措施: Physical therapy (Behavioral)
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.
干预措施: Opioids (Drug)
结局指标
主要结局
Change in Visual Analog Scale (VAS) of subjective pain at dedicated Time Frames listed below.
时间窗: 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.
次要结局
- Roland-Morris Disability Questionnaire at dedicated time frames listed below to assess change.(0 weeks, 1 week, 12 weeks, 6 months)
- QUALEFFO-41 (Quality of Life questionnaire) Scale at dedicated time frames listed below to assess change.(0 weeks, 1 week, 12 weeks, 6 months)
- Patient Health Questionnaire (PHQ-9) at dedicated Time Frames listed below.(0 weeks, 1 week, 12 weeks, 6 months)