A Prospective Case Series: Genicular Embolization Using Doxycycline Sclerotherapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
The goal of this prospective case series is to develop an alternative pain management procedure for patients who are not surgical candidates. The main question it aims to answer is: Is genicular sclerotherapy using doxycycline a safe and effective pain management option for patients with chronic knee pain who are not surgical candidates?
OUTCOME MEASURES:
Primary: Visual Analog Scale (VAS) score at 3 months
Secondary:
- VAS at 12 months
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 months
详细描述
The purpose of this study is to develop an alternative pain management procedure for patients who are not surgical candidates. Using sclerotherapy (a procedure in which a medication is injected into small blood vessels causing them to scar, shrink and collapse) in the small terminal branches of some of the blood vessels in the knee, the aim is to adapt this proven therapy for varicose veins, cysts, and vascular malformations to pain management. Doxycycline will be used as the injectable to perform the procedure. Doxycyline is a FDA approved medication commonly used for bacterial infections and is is frequently used off-label as a sclerosing agent; however, it is not specifically FDA approved for use in sclerotherapy.
This is a pilot study. A pilot study is a small-scale, preliminary study conducted before a larger, more comprehensive research project. Its purpose is to test and refine the research methods, procedures, and instruments, ensuring they are feasible, practical, and reliable.
Visit 1: Consent and treatment procedure: Subjects will be consented and baseline VAS (visual analog scale) and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)will be obtained. Procedure will be performed by one of the study providers as follows: Following sterile cleaning of the skin and administration of lidocaine to anesthetize injection tract, ultrasound guidance will be utilized to isolate target sites of the peripheral vasculature of the genicular artery in one knee. Up to four sites in the index knee may be injected as needed based on pain presentation and physician's discretion. A maximum of 100 milligrams of doxycycline diluted in 10 milliliters of sterile water will be used per subject. Post procedure icing will be performed for 15 minutes to help prevent the occurrence of ischemia and bruising.
Post-operatively, a prescription for either Lortab or Tramadol will be offered and an over the counter pain medication option will be recommended.
If the subject experiences an adverse event, please contact the study provider for an exam, lab-work and/or consultation as needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age or older.
- •KL Score 2-3
- •VA Grade >5
- •Native knee
- •Willing and able to provide consent.
- •Willing and able to complete questionnaires.
- •Willing and able to complete follow up visits.
- •Speak and write fluent English
- •Unilateral knee (if bilateral knee pain, identify knee for procedure)
- •All subjects may be included regardless of sex. Women must be either surgically sterilized postmenopausal defined as having no menstrual periods for 12 consecutive months
排除标准
- •Allergies to doxycycline or any other substances used in procedure
- •Steroid injection in the index knee within the last 90 days
- •Knee surgery on index knee in the last 180 days
研究组 & 干预措施
Doxycycline Genicular Sclerotherapy Arm
Participants in this arm will undergo sclerotherapy using doxycycline to target terminal genicular arteries associated with knee pain. The procedure is performed under ultrasound guidance, and the goal is to evaluate the safety and potential efficacy of doxycycline as a sclerosing agent for managing chronic knee pain symptoms.
干预措施: Doxycycline Injection (Drug)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 3 months post-op
Primary outcome measure will be visual analog scale scores at 3 months post-op. Scores 0-10, 0 being no pain, 10 being the worst pain.
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(1 year post-op)
- Visual Analog Scale (VAS)(1 year post-op)
研究者
Joshua Brandon
Principal Investigator
Campbell Clinic